ASTM F2554-18

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 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 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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 T...

General Information

• Status: Historical
• Publication Date: 31-Oct-2018
• 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

Standards Content (Sample)

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 − 18
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, health, and environmental practices and deter-
localization tool can produce errors. These errors and the
mine the applicability of regulatory limitations prior to use.
orientation of the localization tool are within the scope of this
1.7 This international standard was developed in accor-
practice. The aim is to provide a standardized measurement of
dance with internationally recognized principles on standard-
performance variables by which end-users can compare within
ization established in the Decision on Principles for the
(for example, different fixed reference frames or stylus tools)
Development of International Standards, Guides and Recom-
and between (for example, different manufacturers) different
mendations issued by the World Trade Organization Technical
systems. Parameters to be evaluated include (based upon the
Barriers to Trade (TBT) Committee.
features of the system being evaluated):
(1)Location of a point relative to a coordinate system.
2. Referenced Documents
(2)Relative point to point accuracy (linear). 2
2.1 ASTM Standards:
(3)Repeatability of coordinates of a single point.
E456Terminology Relating to Quality and Statistics
(4)For an optically based system, the range of visible
E2281Practice for Process Capability and Performance
orientations of the reference frames or tools.
Measurement
(5)This method covers all configurations of tool arrays in
2.2 Other References:
the system.
ISO 10360Geometrical Product Specifications (GPS)—
1.2 The system as defined in this practice includes only the
Acceptance and Reverification Tests for Coordinate Mea-
tracking subsystem (optical, magnetic, mechanical, and so
suring Machines (CMM)
forth) stylus, computer, and necessary hardware and software.
3. Terminology
As such, this practice incorporates tests that can be applied to
a prescribed phantom model in a laboratory or controlled
3.1 Definition of Terms Specific to Accuracy Reporting:
setting.
3.1.1 accuracy, n—the closeness of agreement between a
measurement result and an accepted reference value. E456
1.3 This practice defines a standardized reporting format,
which includes definition of the coordinate systems to be used 3.1.1.1 Discussion—The term accuracy, when applied to a
set of measurement results, involves a combination of a
for reporting the measurements, and statistical measures (for
example, mean, standard deviation, maximum error). random component and of a common systematic error or bias
component.
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.38 on Computer Assisted Orthopaedic Surgical Systems. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Nov. 1, 2018. Published December 2018. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 2010. Last previous edition approved in 2010 as F2554–10. DOI Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2554–18. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2554 − 10 F2554 − 18
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. 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
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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E456 Terminology Relating to Quality and Statistics
E2281 Practice for Process Capability and Performance Measurement
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.38
on Computer Assisted Orthopaedic Surgical Systems.
Current edition approved Dec. 1, 2010Nov. 1, 2018. Published January 2011December 2018. Originally approved in 2010. Last previous edition approved in 2010 as
F2554–10. DOI 10.1520/F2554–10.10.1520/F2554–18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2554 − 18
2.2 Other References:
ISO 10360 Geometrical Product Specifications (GPS)—Acceptance and Reverification Tests for Coordinate Measurin
...