1、Designation: F3107 14Standard Test Method forMeasuring Accuracy after Mechanical Disturbances onReference Frames of Computer Assisted Surgery Systems1This standard is issued under the fixed designation F3107; the number immediately following the designation indicates the year oforiginal adoption or,
2、 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 standard will measure the effects on the accuracy ofcomputer assisted surge
3、ry (CAS) systems of the environmentalinfluences caused by equipment utilized for bone preparationduring the intended clinical application for the system. Theenvironmental vibration effect covered in this standard willinclude mechanical vibration from: Cutting saw (sagittal orreciprocating), Burrs, d
4、rills and impact loading. The change inaccuracy from detaching and re-attaching, or disturbing arestrained connection that does not by design require repeatingthe registration process of a reference base will also bemeasured.1.2 It should be noted that one system may need to undergomultiple iteratio
5、ns (one for each clinical application) of thisstandard to document its accuracy during different clinicalapplications since each procedure may have different exposureto outside forces given the surgical procedure variability fromone procedure to the next.1.3 All units of measure will be reported as
6、millimeters forthis standard.1.4 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
7、 prior to use.2. Referenced Documents2.1 ASTM Standards:2E456 Terminology Relating to Quality and StatisticsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF2554 Practice for Measurement of Positional Accuracy ofComputer Assisted Surgical Systems2.2 IS
8、O Standard:3ISO 10360 Geometrical Product Specifications (GPS) Acceptance and re-verification 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 ref
9、erence 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 va
10、lue. 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 largersystematic difference from the accepted reference value isreflected by a larger bias value.3.1.3 maximum error, nthe large
11、st distance between anymeasured point and its corresponding reference position forany trial during a testing procedure.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 particularnumbe
12、r occurs more times than others in the list, it is called amode. The arithmetic mean is what students are taught veryearly to call the “average”. If the list is a statistical population,then the mean of that population is called a population mean.If the list is a statistical sample, we call the resu
13、lting statistic asample mean.3.1.5 measurement range, nsee measurement volume.3.1.6 precision, nthe closeness of agreement betweenindependent measurement results obtained under stipulatedconditions. E4561This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Material
14、s and Devices and is the direct responsibility of SubcommitteeF04.38 on Computer Assisted Orthopaedic Surgical Systems.Current edition approved Dec. 1, 2014. Published January 2015. DOI: 10.1520/F3107-14.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Se
15、rvice at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International,
16、100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.6.1 DiscussionPrecision depends on random errorsand does not relate to the true value or the specified value. Themeasure of precision usually is expressed in terms of impreci-sion and computed as a standard devia
17、tion of the test results.3.1.6.2 DiscussionLess precision is reflected by a largerstandard deviation. “Independent test results” means resultsobtained in a manner not influenced by any previous result onthe same or similar test object. Quantitative measures ofprecision depend critically on the stipu
18、lated conditions. Re-peatability and reproducibility conditions are particular sets ofextreme stipulated conditions.3.1.7 range, R, nthe largest observation minus the small-est observation in a set of values or observations. E456, E22813.1.8 repeatability, nprecision under repeatabilityconditions. E
19、4563.1.8.1 DiscussionRepeatability is one of the concepts orcategories of the precision of a test method. Measures ofrepeatability defined in this compilation are repeatability,standard deviation, and repeatability limit.3.1.9 reproducibility, nprecision under reproducibilityconditions. E4563.1.9.1
20、DiscussionAbility of a test or experiment to beaccurately reproduced, or replicated.3.1.10 resolution, nof a devise/sensor, smallest change itcan detect in the quantity that it is measuring. The resolution isrelated to the precision with which the measurement is made.3.1.11 standard deviation, nthe
21、most usual measure of thedispersion of observed values or results expressed as thepositive square root of the variance. E4563.1.12 variance, nof a random variable, measure of itsstatistical dispersion, indicating how its possible values arespread around the expected value. Where the expected valuesh
22、ows the location of the distribution, the variance indicatesthe scale of the values. A more understandable measure is thesquare root of the variance, called the standard deviation.3.2 Definition of Terms Specific to Surgical Navigation andRobotic Positioning Systems:3.2.1 computer assisted surgery (
23、CAS), nthe use of com-puters to facilitate or enhance Surgical Procedures via the useof three-dimensional space tracking of objects.3.2.2 data integrity, ncondition in which data is identi-cally maintained during any operation, such as transfer,storage, and retrieval.3.2.3 degree of freedom (DOF), n
24、set of independentdisplacements that specify completely the displaced or de-formed position of the body or system.3.2.4 dynamic reference base, na reference element that isintraoperatively attached to a therapeutic object and allowstracking that object. It defines the local coordinate system ofthe t
25、herapeutic object.3.2.5 fiducial, nan artificial object (e.g., screw or sphere)that is implanted into, or a feature created on, a therapeuticobject prior to virtual object acquisition to facilitate registra-tion.3.2.6 marker, na single indicator on a reference element ordynamic reference base where
26、a collection of these indicatorsare utilized to define an object, tool or reference frame in space.3.2.7 measurement volume, nmeasuring range of atracker, stated as simultaneous limits on all spatial coordinatesmeasured by the tracker. ISO 10360-13.2.8 navigation system, na device consisting of a co
27、m-puter with associated software and a localizer that tracksreference elements attached to surgical instruments or implantsas well as one or more dynamic reference bases attached to thetherapeutic object. It provides real-time feedback of the per-formed action by visualizing it within the virtual en
28、vironment.3.2.9 reference element, na device attached to surgicalinstruments and implants and other devices that enablesdetermination of position and orientation in 3d space (up to 6degrees of freedom) of these by means of a tracker. It definesthe local coordinate system of this instrument or implan
29、t.3.2.10 reference point, na designated point on the phan-tom or sawbone used to repeat measures and to make com-parisons to after each trial is performed within the standard.3.2.11 referencing, ntracking of a therapeutic object bymeans of a dynamic reference base.3.2.12 registration, nthe determina
30、tion of the transforma-tion between the coordinate spaces of the therapeutic andvirtual objects or between the coordinate spaces of two virtualobjects. A registration is rigid if it consists only of rotations,translations, and scaling; it is non-rigid if it also compriseslocal or global distortions.
31、3.2.13 robotic positioning system, nuse of an active me-chanical (mechatronic) device to position an instrument guideat a specified location in 3d space (up to 6 degrees of freedom).3.2.14 stylus, na mechanical device consisting of a stylustip and a shaft. The stylus tip is the physical element that
32、establishes the contact with the workpiece. ISO 10360-13.2.15 tool calibration, nthe pre- or intraoperative deter-mination of the location of points-of-interest on a navigatedinstrument (e.g., its tip position, axis) in relation to a referenceframe (e.g., the attached reference element for a tracked
33、instrument).3.2.16 tracker, na device that measures the spatial loca-tion and orientation of surgical instruments, implants, or thetherapeutic object that are instrumented with reference ele-ments or a dynamic reference base respectively. A tracker maymeasure based on infrared light (see tracking, a
34、ctive andtracking, passive), ultrasound, electromagnetic fields, mechani-cal linkage, video streams, etc.3.2.17 tracking, active, na tracking technology that usesmarkers that emit energy (e.g., an infrared light based trackingtechnology that uses pulsed LEDs as markers, ultrasound,electromagnetic fi
35、elds, etc.).3.2.18 tracking, passive, na tracking technology that usesmarkers that absorb or reflect externally produced energy (e.g.,an light based tracking technology that uses reflective spheresor similar objects as markers).F3107 1424. Summary of Test Method4.1 Reference Base Attachment Toleranc
36、eThis portion ofthe standard will evaluate the robustness of the reference baseand tracking array attachment to outside forces and repeateduse in an environment and application that is clinically relevantto their intended use. These forces will simulate operatingroom incidental contacts from end use
37、rs and assistants. Theresults will allow comparison of the stability and repeatabilityof the tolerances and strength of the reference base attachmentof the markers used for the CAS system. Utilization of aphantom will be used as described in F2554-10 for attachmentof the reference base in a clinical
38、ly applicable manner to theintended use of the CAS system being tested.4.2 The second portion of this standard will entail testingtypical situations in the operating room that occur during asurgical procedure that can impact the accuracy of the CASsystem that involves a computer marker attachment to
39、 a bonylandmark. This portion of the standard will involve attachmentof a reference base to the chosen model according to manu-facturers guidelines and performing procedures using a mate-rial of similar density and mechanical property of the appli-cable bony anatomical region being tested. Measureme
40、nt of amarked point on the chosen test specimen which will berepeated with a pointing device to a set of six points on the testspecimen with removal of the tracking array from the referencebase, reattachment and repeat. This procedure will be repeatedfor sagittal saw, drilling and impaction procedur
41、es. Abovecompleted for a minimum of 6 trials with the mean, STD, and95% confidence interval calculated and tabulated.5. Significance and Use5.1 The purpose of this practice is to provide data that canbe used for comparison and evaluation of the accuracy ofdifferent CAS systems.5.2 The use of CAS sys
42、tems and robotic tracking systems isbecoming increasingly common and requires a degree of trustby the user that the data provided by the system meetsnecessary accuracy requirements. In order to evaluate thepotential use of these systems, and to make informed decisionsabout suitability of a system fo
43、r a given procedure, objectiveperformance data of such systems are necessary. While the enduser will ultimately want to know the accuracy parameters ofa system under clinical application, the first step must be tocharacterize the digitization accuracy of the tracking subsystemin a controlled environ
44、ment under controlled conditions.5.3 In order to make comparisons within and betweensystems, a standardized way of measuring and reporting pointaccuracy is needed. Parameters such as coordinate system,units of measure, terminology, and operational conditions mustbe standardized.6. Apparatus6.1 Stand
45、ardized measurement object (phantom). See Fig.1.6.2 System to be evaluated, including tracking system,stylus or any pointing device, and associated required hardwareand software. While the software may be custom written for thetasks outlined in this standard it should use exactly the sameFIG. 1 Phan
46、tomF3107 143algorithms and methodologies being implemented in thecommercial/clinical system to be assessed under this standard.6.3 A chosen biomechanical test specimen that is anchoredor rigidly fixed to the phantom and placed on a table will beutilized. A standard reference base attachment and manu
47、fac-turer application tools will be utilized during the procedure.See Fig. 1.7. Hazards7.1 The hazards from performing the standard are fromhandling the instruments and from the saw and drill bits. Nohuman or biological tissues are utilized so no biohazard exists.8. ProcedureReference Base Attachmen
48、t Test8.1 Complete steps 8.1 to 8.33 in F2554-10 utilizing thephantom described in Appendix A2 but with utilizing onedetermined point on the phantom. Note that the reference basemust be part of the CAS system being tested (those typical oftracking bony reference landmarks and instruments) and at-tac
49、hed to the phantom. It cannot be a permanent part of thephantom and must include a reference base attachment for theactive or passive markers. If the array is not detachable fromthe reference base then it is left alone for all tests in thisstandard.8.2 Measure the chosen point on the phantom for a baselinecomparison. Next, detach the reference base from the phantomcompletely, reattach and then perform a measurement on thesame point of the phantom as in 8.1.1. Steps 8.1.18.1.2 will becompleted 6 times with the same point registered and theMea
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