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Abstract:
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Often in-vivo or in-vitro diagnostic devices (or tests) are cleared through 510(k) pathway where the subject device is compared to a predicate device which acts as a comparator device. The study comparing the subject device to a predicate device may or may not involve a clinical reference standard (also known as 'gold standard'). Issues related to commonly used but not necessarily appropriate methods to evaluate agreement, between the subject device and a comparator device (predicate or clinical reference standard) with dichotomous output are discussed to show why they are not recommended. Further, measures of agreement to evaluate a subject device compared against a comparator device (not a clinical reference standard) are provided with discussion.
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