Abstract:
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In new diagnostic device application, such as 510(k), the new measurement method or diagnostic device is often compared to a predicate device or a comparator. We need to demonstrate that the diagnostic performance of the subject device is substantially equivalent to the predicate's. In clinical trials, both methods are often applied to the same set of patients producing correlated dataset. In this talk, we compare various parametric and non-parametric methods to address the issue and discuss the analysis results through simulation studies.
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