ASTM F2554-2018 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.pdf

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1、Designation: F2554 10F2554 18Standard Practice forMeasurement of Positional Accuracy of Computer AssistedSurgical Systems1This standard is issued under the fixed designation F2554; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, th

2、e year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice addresses the techniques of measurement and reporting of basic static performance (accuracy, r

3、epeatability,and so forth) of surgical navigation and/or robotic positioning devices under defined conditions. The scope covers the trackingsubsystem, testing only in this practice the accuracy and repeatability of the system to locate individual points in space. A pointin space has no orientation;

4、only multi-dimensional objects have orientation. Therefore, orientation of objects is not within thescope of this practice. However, in localizing a point the different orientations of the localization tool can produce errors. Theseerrors and the orientation of the localization tool are within the s

5、cope of this practice. The aim is to provide a standardizedmeasurement of performance variables by which end-users can compare within (for example, different fixed reference frames orstylus tools) and between (for example, different manufacturers) different systems. Parameters to be evaluated includ

6、e (based uponthe 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 fram

7、es 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 te

8、sts that can be applied to a prescribedphantom 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 forreporting the measurements, and statistical measures (for example, mean, standard de

9、viation, maximum error).1.4 This practice will serve as the basis for subsequent standards for specific tasks (cutting, drilling, milling, reaming, biopsyneedle 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 meas

10、urement 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 responsibilityof the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine theapp

11、licability of regulatory limitations prior to use.1.7 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the

12、 World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E456 Terminology Relating to Quality and StatisticsE2281 Practice for Process Capability and Performance Measurement1 This practice is under the jurisdiction of ASTM Committee F04 on Medi

13、cal and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.38on 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

14、asF255410. DOI 10.1520/F255410.10.1520/F255418.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This document

15、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. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appro

16、priate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.2 Other References:ISO 10360 Geometrical Product Specificati

17、ons (GPS)Acceptance and Reverification Tests for Coordinate MeasuringMachines (CMM)3. Terminology3.1 Definition of Terms Specific to Accuracy Reporting:3.1.1 accuracy, nthe closeness of agreement between a measurement result and an accepted reference value. E4563.1.1.1 DiscussionThe term accuracy, w

18、hen applied to a set of measurement results, involves a combination of a random component and of a commonsystematic error or bias component.3.1.2 bias, nthe difference between the expectation of the measurement results and an accepted reference value. E4563.1.2.1 DiscussionBias is the total systemat

19、ic error as contrasted to random error.There may be one or more systematic error components contributingto the bias. A larger systematic difference from the accepted reference value is reflected by a larger bias value.3.1.3 maximum error, nthe largest distance between any measured point and its corr

20、esponding reference position (forexample, as measured by CMM) for any trial during a testing procedure.3.1.4 mean, nthe arithmetic mean (or simply the mean) of a list of numbers is the sum of all the members of the list dividedby the number of items in the list. If one particular number occurs more

21、times than others in the list, it is called a mode. Thearithmetic mean is what students are taught very early to call the “average”. If the list is a statistical population, then the meanof that population is called a population mean. If the list is a statistical sample, we call the resulting statis

22、tic a sample mean.3.1.5 measurement range, nsee measurement volume.3.1.6 precision, nthe closeness of agreement between independent measurement results obtained under stipulated conditions.E4563.1.6.1 DiscussionPrecision depends on random errors and does not relate to the true value or the specified

23、 value. The measure of precision usuallyis expressed in terms of imprecision and computed as a standard deviation of the test results. The standard deviation is expressedas:S 5!(i51N Xi 2X!2N 21S 5!(i51N Xi 2X!2N 21Less precision is reflected by a larger standard deviation. “Independent test results

24、” means results obtained in a manner notinfluenced by any previous result on the same or similar test object. Quantitative measure of precision depends critically onthe stipulated conditions. Repeatability and reproducibility conditions are particular sets of extreme stipulated conditions.3.1.7 rang

25、e, R, nthe largest observation minus the smallest observation in a set of values or observations. E456, E22813.1.8 repeatability, nprecision under repeatability conditions. E4563.1.8.1 DiscussionRepeatability is one of the concepts or categories of the precision of a test method. Measures of repeata

26、bility defined in thiscompilation are repeatability, standard deviation, and repeatability limit.3.1.9 reproducibility, nprecision under reproducibility conditions. E4563.1.9.1 DiscussionAbility of a test or experiment to be accurately reproduced, or replicated.F2554 1823.1.10 resolution, nof a devi

27、ce/sensor, the smallest change the device or sensor can detect in the quantity that it is measuring.The resolution is related to the precision with which the measurement is made.3.1.11 standard deviation, nthe most usual measure of the dispersion of observed values or results expressed as the positi

28、vesquare root of the variance. E4563.1.12 variance, nof a random variable, measure of its statistical dispersion, indicating how its possible values are spreadaround the expected value. Where the expected value shows the location of the distribution, the variance indicates the scale of thevalues. A

29、more understandable measure is the square root of the variance, called the standard deviation.3.2 Definition of Terms Specific to Surgical Navigation and Robotic Positioning Systems:3.2.1 data integrity, ncondition in which data is identically maintained during any operation, such as transfer, stora

30、ge, andretrieval.3.2.2 degree of freedom (DOF), nset of independent displacements that specify completely the displaced or deformed positionof the body or system.3.2.3 dynamic reference base, na reference element that is intraoperatively attached to a therapeutic object and allows trackingthat objec

31、t. It defines the local coordinate system of the therapeutic object.3.2.4 fiducial, nan artificial object (for example, screw or sphere) that is implanted into, or a feature created on, a therapeuticobject prior to virtual object acquisition to facilitate registration.3.2.5 marker, na single 3-degre

32、e-of-freedom indicator on a reference element or dynamic reference base.3.2.6 measurement volume, nmeasuring range of a tracker, stated as simultaneous limits on all spatial coordinates measuredby the tracker. ISO 10360-13.2.7 navigation system, na device consisting of a computer with associated sof

33、tware and a localizer that tracks referenceelements attached to surgical instruments or implants as well as one or more dynamic reference bases attached to the therapeuticobject. It provides real-time feedback of the performed action by visualizing it within the virtual environment.3.2.8 reference e

34、lement, na device attached to surgical instruments and implants and other devices that enables determinationof position and orientation in 3d space (up to 6 degrees of freedom) of these by means of a tracker. It defines the local coordinatesystem of this instrument or implant.3.2.9 referencing, ntra

35、cking of a therapeutic object by means of a dynamic reference base.3.2.10 registration, nthe determination of the transformation between the coordinate spaces of the therapeutic and virtualobjects or between the coordinate spaces of two virtual objects. A registration is rigid if it consists only of

36、 rotations, translations,and scaling; it is non-rigid if it also comprises local or global distortions.3.2.11 robotic positioning system, nuse of an active mechanical (mechatronic) device to position an instrument guide at aspecified location in 3d space (up to 6 degrees of freedom).3.2.12 stylus, n

37、a mechanical device consisting of a stylus tip and a shaft. The stylus tip is the physical element that establishesthe contact with the workpiece. ISO 10360-13.2.13 tool calibration, nthe pre- or intraoperative determination of the location of points-of-interest on a navigatedinstrument (for example

38、, its tip position, axis) in relation to a reference frame (for example, the attached reference element for atracked instrument).3.2.14 tracker, na device that measures the spatial location and orientation of surgical instruments implants, or the therapeuticobject that are instrumented with referenc

39、e elements or a dynamic reference base respectively. A tracker may measure based oninfrared light (see tracking, active and tracking, passive), ultrasound, electromagnetic fields, mechanical linkage, video streams,and so forth.3.2.15 tracking, active, na tracking technology that uses markers that em

40、it energy (for example, an infrared light basedtracking technology that uses pulsed LEDs as markers, ultrasound, electromagnetic fields, and so forth).3.2.16 tracking, passive, na tracking technology that uses markers that absorb or reflect externally produced energy. (forexample, an light based tra

41、cking technology that uses reflective spheres or similar objects as markers).3.3 Others:3.3.1 computer assisted surgery (CAS), nthe use of computers to facilitate or enhance Surgical Procedures via the use ofthree-dimensional space tracking of objects.3.3.2 coordinate measuring machine (CMM), nmeasu

42、ring system with the means to move a stylus and capability to determinespatial coordinates on a work piece surface. ISO 10360-13.3.3 phantom, nstandardized measurement object. See Appendix X1 for recommendations regarding phantom design.Specific points referenced in this practice are with regards to

43、 the recommended phantom design in Appendix X1.F2554 1834. Summary of Practice4.1 This practice provides recommendations for the collection, analysis, and presentation of data regarding the positionalaccuracy of surgical navigation and robotic positioning systems.4.2 Data to be provided include meas

44、ured statistical distribution, maximum error, mean, and standard deviations, 5th and 95thpercentiles of location and orientation accuracy.4.3 This practice provides protocols (Section 8) for measuring accuracy of the tracking system (optical, magnetic, mechanical,and so forth) made under repeatable

45、conditions. Subsequent standards will address the system along with any necessary imagingmodality (fluoroscopy, computed tomography, magnetic resonance imaging, ultrasound, and so forth) for image based systems, andthe software for registering the images or the imageless data to the patient. Additio

46、nal standards will also address task specificprocedures and surgical applications (joint arthroplasty, osteotomy, tumor biopsy and/or resection, laproscopy, pedicle screwinsertion, brain surgery, and so forth).5. Significance and Use5.1 The purpose of this practice is to provide data that can be use

47、d 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 oftrust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the

48、potentialuse of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performancedata of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system underclinical application, the first step mu

49、st be to characterize the digitization accuracy of the tracking subsystem in a controlledenvironment under controlled conditions.5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy isneeded. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.6. Apparatus6.1 Standardized measurement object (phantom). See X1.1.6.2 System to be evaluated, including tracking system, stylus, and associated required hardware and sof