TL24: Diagnostic Imaging Studies
*Lakshmi Vishnuvajjala, FDA/CDRH 


Diagnostic Imaging studies usually involve a clinician making a call based on images of chest, lung, breast etc. Area under the ROC curve, which is a summary measure is sometimes used to measure performance of these imaging devices. While the measure can provide useful information, using only a summary measure ignores a lot of useful information. This is particularly true when consequences of false positives and false negatives are vastly different.