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ASTM F2554-10

(Practice)

Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

SIGNIFICANCE AND USE
The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.
The use of surgical navigation and robotic positioning 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.
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 measure, terminology, and operational conditions must be standardized.
SCOPE
1.1 This practice addresses the techniques of measurement and reporting of basic static performance (accuracy, repeatability, and so forth) of surgical navigation and/or robotic positioning devices under defined conditions. The scope covers the tracking subsystem, testing only in this practice the accuracy and repeatability of the system to locate individual points in space. A point in space has no orientation; only multi-dimensional 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 localization tool can produce errors. These errors and the orientation of the localization tool 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 (for example, different fixed reference frames or stylus tools) and between (for example, different manufacturers) different systems. Parameters to be evaluated include (based upon the features of the system being evaluated):
(1) Location of a point relative to a coordinate system.
(2) Relative point to point accuracy (linear).
(3) Repeatability of coordinates of a single point.
(4) For an optically based system, the range of visible orientations of the reference frames or tools.
(5) This method covers all configurations of tool arrays in the system.
1.2 The system as defined in this practice includes only the tracking subsystem (optical, magnetic, mechanical, and so forth) stylus, computer, and necessary hardware and software. As such, this practice incorporates tests that can be applied to a prescribed phantom model in a laboratory or controlled setting.
1.3 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, standard deviation, maximum error).
1.4 This practice will serve as the basis for subsequent standards for specific tasks (cutting, drilling, milling, reaming, biopsy needle placement, and so forth) and surgical applications.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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-2010
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

Relations

Referred By
ASTM F3107-14(2023) - Standard Test Method for Measuring Accuracy After Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
Effective Date
01-Dec-2010

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ASTM F2554-10 - Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical SystemsASTM F2554-10 - Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
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ASTM F2554-10 - Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical 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: F2554 − 10
Standard Practice for
Measurement of Positional Accuracy of Computer Assisted
1
Surgical Systems
This standard is issued under the fixed designation F2554; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.4 This practice will serve as the basis for subsequent
standards for specific tasks (cutting, drilling, milling, reaming,
1.1 This practice addresses the techniques of measurement
biopsy needle placement, and so forth) and surgical applica-
and reporting of basic static performance (accuracy,
tions.
repeatability,andsoforth)ofsurgicalnavigationand/orrobotic
positioningdevicesunderdefinedconditions.Thescopecovers 1.5 The values stated in SI units are to be regarded as
the tracking subsystem, testing only in this practice the standard. No other units of measurement are included in this
accuracy and repeatability of the system to locate individual standard.
points in space. A point in space has no orientation; only
1.6 This standard does not purport to address all of the
multi-dimensional objects have orientation. Therefore, orien-
safety concerns, if any, associated with its use. It is the
tation of objects is not within the scope of this practice.
responsibility of the user of this standard to establish appro-
However, in localizing a point the different orientations of the
priate safety and health practices and determine the applica-
localization tool can produce errors. These errors and the
bility of regulatory limitations prior to use.
orientation of the localization tool are within the scope of this
practice. The aim is to provide a standardized measurement of
2. Referenced Documents
performance variables by which end-users can compare within
2
2.1 ASTM Standards:
(for example, different fixed reference frames or stylus tools)
E456Terminology Relating to Quality and Statistics
and between (for example, different manufacturers) different
E2281Practice for Process and Measurement Capability
systems. Parameters to be evaluated include (based upon the
Indices
features of the system being evaluated):
2.2 Other References:
(1)Location of a point relative to a coordinate system.
ISO 10360Geometrical Product Specifications (GPS)—
(2)Relative point to point accuracy (linear).
Acceptance and Reverification Tests for Coordinate Mea-
(3)Repeatability of coordinates of a single point.
suring Machines (CMM)
(4)For an optically based system, the range of visible
orientations of the reference frames or tools.
3. Terminology
(5)This method covers all configurations of tool arrays in
the system. 3.1 Definition of Terms Specific to Accuracy Reporting:
3.1.1 accuracy, n—the closeness of agreement between a
1.2 The system as defined in this practice includes only the
measurement result and an accepted reference value. E456
tracking subsystem (optical, magnetic, mechanical, and so
3.1.1.1 Discussion—The term accuracy, when applied to a
forth) stylus, computer, and necessary hardware and software.
set of measurement results, involves a combination of a
As such, this practice incorporates tests that can be applied to
random component and of a common systematic error or bias
a prescribed phantom model in a laboratory or controlled
component.
setting.
3.1.2 bias, n—the difference between the expectation of the
1.3 This practice defines a standardized reporting format,
measurement results and an accepted reference value. E456
which includes definition of the coordinate systems to be used
3.1.2.1 Discussion—Bias is the total systematic error as
for reporting the measurements, and statistical measures (for
contrasted to random error. There may be one or more
example, mean, standard deviation, maximum error).
systematic error components contributing to the bias. A larger
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
2
Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.38 on Computer Assisted Orthopaedic Surgical Systems. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Dec. 1, 2010. Published January 2011. DOI 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F2554–10. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2554 − 10
systematic difference from the accepted reference value is shows the location of the distribution, the variance indicates
refl
...

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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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5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.  
5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
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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):
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(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.  
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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.  
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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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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.  
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SCOPE
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ASTM
ASTM F2554-22(Practice)
Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.  
5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the 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 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.

  • Standard
    9 pages
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  • Standard
    9 pages
    English language
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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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    16 pages
    English language
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  • Standard
    16 pages
    English language
    sale 15% off