ASTM_F_2554_-_10.pdf

Designation:F255410Standard 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,the 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 measurementand reporting of basic static performance(accuracy,repeatability,and so forth)of surgical navigation and/or roboticpositioning devices under defined conditions.The scope coversthe tracking subsystem,testing only in this practice theaccuracy and repeatability of the system to locate individualpoints in space.A point in space has no orientation;onlymulti-dimensional objects have orientation.Therefore,orien-tation of objects is not within the scope of this practice.However,in localizing a point the different orientations of thelocalization tool can produce errors.These errors and theorientation of the localization tool are within the scope of thispractice.The aim is to provide a standardized measurement ofperformance variables by which end-users can compare within(for example,different fixed reference frames or stylus tools)and between(for example,different manufacturers)differentsystems.Parameters to be evaluated include(based upon thefeatures 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 visibleorientations of the reference frames or tools.(5)This method covers all configurations of tool arrays inthe system.1.2 The system as defined in this practice includes only thetracking subsystem(optical,magnetic,mechanical,and soforth)stylus,computer,and necessary hardware and software.As such,this practice incorporates tests that can be applied toa prescribed phantom model in a laboratory or controlledsetting.1.3 This practice defines a standardized reporting format,which includes definition of the coordinate systems to be usedfor reporting the measurements,and statistical measures(forexample,mean,standard deviation,maximum error).1.4 This practice will serve as the basis for subsequentstandards for specific tasks(cutting,drilling,milling,reaming,biopsy needle placement,and so forth)and surgical applica-tions.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E456 Terminology Relating to Quality and StatisticsE2281 Practice for Process and Measurement CapabilityIndices2.2 Other References:ISO 10360 Geometrical Product Specifications(GPS)Acceptance and Reverification Tests for Coordinate Mea-suring Machines(CMM)3.Terminology3.1 Definition of Terms Specific to Accuracy Reporting:3.1.1 accuracy,nthe closeness of agreement between ameasurement result and an accepted reference value.E4563.1.1.1 DiscussionThe term accuracy,when applied to aset of measurement results,involves a combination of arandom component and of a common systematic error or biascomponent.3.1.2 bias,nthe difference between the expectation of themeasurement results and an accepted reference value.E4563.1.2.1 DiscussionBias is the total systematic error ascontrasted to random error.There may be one or moresystematic error components contributing to the bias.A larger1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.38 on Computer Assisted Orthopaedic Surgical Systems.Current edition approved Dec.1,2010.Published January 2011.DOI 10.1520/F255410.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 systematic difference from the accepted reference value isreflected by a larger bias value.3.1.3 maximum error,nthe largest distance between anymeasured point and its corresponding reference position(forexample,as measured by CMM)for any trial during a testingprocedure.3.1.4 mean,nthe arithmetic mean(or simply the mean)ofa list of numbers is the sum of all the members of the listdivided by the number of items in the list.If one particularnumber occurs more times than others in the list,it is