Online Program Home
My Program

Abstract Details

Activity Number: 646
Type: Topic Contributed
Date/Time: Thursday, August 4, 2016 : 8:30 AM to 10:20 AM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #320581
Title: Different Success Criteria in the Performance Evaluation of Diagnostic Devices
Author(s): Norberto Pantoja-Galicia* and Gene Pennello
Companies: FDA/CDRH and FDA/CDRH/OSB/DBS
Keywords: medical devices ; diagnostic ; success criteria ; adherence ; test errors ; ROC
Abstract:

Establishing adequate success criteria to evaluate the performance of diagnostic devices depends on several factors. These include the intended use of the medical test, how results provided by the diagnostic will be interpreted by the user, and clinical claims. Different types of success criteria to evaluate the performance of diagnostics will be discussed taking into consideration, for example, whether the device is intended to be used as an adjunct or as a replacement to other established diagnostics, benefits and risks from increased adherence to testing, and implicit or explicit tradeoff between false positive and false negative test errors.


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

Back to the full JSM 2016 program

 
 
Copyright © American Statistical Association