Online Program Home
My Program

Abstract Details

Activity Number: 527 - Diagnostic Tests: Student Papers and Correlated Data
Type: Contributed
Date/Time: Wednesday, August 1, 2018 : 10:30 AM to 12:20 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #328410 Presentation
Title: Methods for Diagnostic Performance Comparison with Correlated Data
Author(s): Xuan Ye*
Companies: U.S. Food and Drug Administration
Keywords: diagnostic; correlated; Z-test; Bootstrap; Bayesian; Power
Abstract:

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.


Authors who are presenting talks have a * after their name.

Back to the full JSM 2018 program