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ASTM F3107-14

(Test Method)

Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.  
5.2 The use of CAS systems and robotic tracking systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting point accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.
SCOPE
1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: Cutting saw (sagittal or reciprocating), Burrs, drills and impact loading. The change in accuracy from detaching and re-attaching, or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.  
1.2 It should be noted that one system may need to undergo multiple iterations (one for each clinical application) of this standard to document its accuracy during different clinical applications since each procedure may have different exposure to outside forces given the surgical procedure variability from one procedure to the next.  
1.3 All units of measure will be reported as millimeters for this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
30-Nov-2014
ICS
35.240.80 - IT applications in health care technology
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.38 - Computer Assisted Orthopaedic Surgical Systems
Current Stage
Ref Project

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ASTM F3107-14 - Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery SystemsASTM F3107-14 - Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
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ASTM F3107-14 - Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3107 − 14
Standard Test Method for
Measuring Accuracy after Mechanical Disturbances on
1
Reference Frames of Computer Assisted Surgery Systems
This standard is issued under the fixed designation F3107; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Computer Assisted Surgical Systems
3
2.2 ISO Standard:
1.1 This standard will measure the effects on the accuracy of
computer assisted surgery (CAS) systems of the environmental ISO 10360 Geometrical Product Specifications (GPS) —
Acceptance and re-verification tests for coordinate mea-
influences caused by equipment utilized for bone preparation
during the intended clinical application for the system. The suring machines (CMM)
environmental vibration effect covered in this standard will
3. Terminology
include mechanical vibration from: Cutting saw (sagittal or
reciprocating), Burrs, drills and impact loading. The change in
3.1 Definition of Terms Specific to Accuracy Reporting:
accuracy from detaching and re-attaching, or disturbing a
3.1.1 accuracy, n—the closeness of agreement between a
restrained connection that does not by design require repeating
measurement result and an accepted reference value. E456
the registration process of a reference base will also be
3.1.1.1 Discussion—The term accuracy, when applied to a
measured.
set of measurement results, involves a combination of a
random component and of a common systematic error or bias
1.2 It should be noted that one system may need to undergo
component.
multiple iterations (one for each clinical application) of this
standard to document its accuracy during different clinical
3.1.2 bias, n—the difference between the expectation of the
applications since each procedure may have different exposure
measurement results and an accepted reference value. E456
to outside forces given the surgical procedure variability from
3.1.2.1 Discussion—Bias is the total systematic error as
one procedure to the next.
contrasted to random error. There may be one or more
systematic error components contributing to the bias. A larger
1.3 All units of measure will be reported as millimeters for
systematic difference from the accepted reference value is
this standard.
reflected by a larger bias value.
1.4 This standard does not purport to address all of the
3.1.3 maximum error, n—the largest distance between any
safety concerns, if any, associated with its use. It is the
measured point and its corresponding reference position for
responsibility of the user of this standard to establish appro-
any trial during a testing procedure.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
3.1.4 mean, n—the arithmetic mean (or simply the mean) of
a list of numbers is the sum of all the members of the list
2. Referenced Documents
divided by the number of items in the list. If one particular
2
number occurs more times than others in the list, it is called a
2.1 ASTM Standards:
mode. The arithmetic mean is what students are taught very
E456 Terminology Relating to Quality and Statistics
early to call the “average”. If the list is a statistical population,
E691 Practice for Conducting an Interlaboratory Study to
then the mean of that population is called a population mean.
Determine the Precision of a Test Method
If the list is a statistical sample, we call the resulting statistic a
F2554 Practice for Measurement of Positional Accuracy of
sample mean.
3.1.5 measurement range, n—see measurement volume.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical
3.1.6 precision, n—the closeness of agreement between
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
independent measurement results obtained under stipulated
F04.38 on Computer Assisted Orthopaedic Surgical Systems.
conditions. E456
Current edition approved Dec. 1, 2014. Published January 2015. DOI: 10.1520/
F3107-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3107 − 14
3.1.6.1 Discussion—Precision depends on random errors 3.2.6 marker, n—a si
...

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Standard Test Method for Measuring Accuracy After Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.  
5.2 The use of CAS systems and robotic tracking systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
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1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.  
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1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.  
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1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):
(1) Accuracy of a single point relative to a coordinate system.
(2) Sensitivity of tracking accuracy due to changes in pointer orientation.
(3) Relative point-to-point accuracy.  
1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume.  
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4.1 Tissue-engineered cartilage is prepared by seeding stem cells or chondrocytes in a three-dimensional biodegradable scaffold under controlled growth conditions. It is expected that the cells will differentiate towards chondrogenic lineage and produce an ample amount of cartilage extracellular matrix proteins, proteoglycans, and collagen type-II. Longitudinal assessment is needed weekly for the first few weeks in vitro and monthly at a later stage in vivo to determine the growth rate of tissue-engineered cartilage. Traditional testing methods such as histological staining, mechanical testing, and qPCR are invasive, destructive, and cannot be performed in vivo after the transplantation of engineered tissue as a regenerative treatment. In the regenerative medicine of cartilage, it is important to evaluate whether the implanted tissue regenerates as an articular cartilage over time. MRI is the only available non-invasive imaging modality that is utilized for post-operative monitoring and assessment of cartilage regeneration in clinics. Therefore, it is important to evaluate tissue-engineered cartilage using MRI at the preclinical stage as well.  
4.7.1 The change in calculated relaxation rate, R2(ECM), using Eq 1 have been found to be positively correlated with tissue growth (3, 6).
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4.1 Purpose—Practices to be employed for the radiographic examination of materials and components with neutrons using digital neutron detectors are outlined herein. They are intended as a guide for the assessment of a digital neutron radiograph’s characteristics. For information on neutron beam lines for imaging and film neutron radiography, refer to Guide E748.  
4.2 Limitations—Acceptance standards have not been established for any material or production process. Neutron radiography, whether performed by means of a reactor, an accelerator, subcritical assembly, or radioactive source, will be consistent in sensitivity and spatial resolution only if the consistency of all details of the technique, such as neutron source, collimation, geometry, imaging system, etc., are maintained. This guide is limited to the use of digital neutron detectors in combination with neutron conversion materials for image recording. This guide is intended for use with thermal and cold neutron spectrums. The production of thermal neutron radiographs by employing the use of film and appropriate conversion screens is covered in Guide E748.  
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4.4 Other Aspects of the Neutron Radiographic Process—For many important aspects of neutron radiography such as technique, files, viewing of radiographs, storage of radiographs, film processing, and record keeping, refer to Guide E94, which covers these aspects for X-ray radiography. (See Section 2.)
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5.1 Personnel that are responsible for the creation, transfer, and storage of computed radiography NDE data will use this practice. This practice will define a set of information modules that along with the Practice E2339 and the DICOM standard will provide a standard means to organize CR inspection data. The CR inspection data may be displayed and analyzed on any device that conforms to the standard. Personnel wishing to view any CR inspection data stored in accordance with Practice E2339 may use this practice to help them decode and display the data contained in the DICONDE compliant inspection record.
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Standard Guide for Data Fields for Computerized Transfer of Digital Radiological Examination Data

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3.1 The primary use of this guide is to provide a standardized approach for the data file to be used for the transfer of digital radiological data from one user to another where the two users are working with dissimilar systems. This guide describes the contents, both required and optional for an intermediate data file that can be created from the native format of the radiological system on which the data was collected and that can be converted into the native format of the receiving radiological data analysis system. This guide will also be useful in the archival storage and retrieval of radiological data as either a data format specifier or as a guide to the data elements which should be included in the archival file.  
3.2 Although the recommended field listing includes more than 100 field numbers, only about half of those are regarded as essential and are marked Footnote C in Table 1. Fields so marked must be included in the data base. The other fields recommended provide additional information that a user will find helpful in understanding the radiological image and examination result. These header field items will, in most cases, make up only a very small part of a radiological examination file. The actual stream of radiological data that make up the image will take up the largest part of the data base. Since a radiological image file will normally be large, the concept of data compression will be considered in many cases. Compressed data should be noted, along with a description of the compression method, as indicated in Field No. 92 (see Table 1). (A) Field numbers are for reference only. They do not imply a necessity to include all these fields in any specific data base nor imply a requirement that fields used be in this particular order.(B) Units listed first are SI; those in parentheses are inch-pound (English).(C) Denotes essential field for computerization of examination results, regardless of examination method.(D) Denotes essential field for radiogra...
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1.1 This guide provides a listing and description of the fields that are recommended for inclusion in a digital radiological examination data base to facilitate the transfer of such data. This guide sets guidelines for the format of data fields for computerized transfer of digital image files obtained from radiographic, radioscopic, computed radiographic, or other radiological examination systems. The field listing includes those fields regarded as necessary for inclusion in the data base: (1) regardless of the radiological examination method (as indicated by Footnote C in Table 1), (2) for radioscopic examination (as indicated by Footnote F in Table 1), and (3) for radiographic examination (as indicated by Footnote D in Table 1). In addition, other optional fields are listed as a reminder of the types of information that may be useful for additional understanding of the data or applicable to a limited number of applications.  
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Standard Test Method for Measuring Accuracy After Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.  
5.2 The use of CAS systems and robotic tracking systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting point accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.
SCOPE
1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.  
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1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measurement, terminology, and operational conditions must be standardized.
SCOPE
1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):
(1) Accuracy of a single point relative to a coordinate system.
(2) Sensitivity of tracking accuracy due to changes in pointer orientation.
(3) Relative point-to-point accuracy.  
1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume.  
1.2 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, RMS, and maximum error).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, except for angular measurements, which may be reported in terms of radians or degrees.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM E2767-21(Practice)
Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for X-ray Computed Tomography (CT) Test Methods

SIGNIFICANCE AND USE
5.1 Personnel that are responsible for the creation, transfer, and storage of X-ray tomographic NDE data will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize X-ray tomography test parameters and results. The X-ray CT test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any tomographic inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
SCOPE
1.1 This practice facilitates the interoperability of X-ray computed tomography (CT) imaging equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE test results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to X-ray CT test methods.  
1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from tomographic test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the X-ray CT technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology.  
1.3 This practice does not specify:  
1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard.  
1.3.2 The implementation details of any features of the standard on a device claiming conformance.  
1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance.  
1.4 Units—Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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