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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(1) Accuracy of a single point relative to a coordinate system.
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(2) Sensitivity of tracking accuracy due to changes in pointer orientation.
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(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.