Diagnostic clinical performance study

In FDA's view of pivotal studies, a diagnostic study reports agreement measures such as sensitivity and specificity rather than patient outcomes. The choice and quality of the clinical reference standard largely decide how credible the results are.

A study in which the performance of a diagnostic device is characterized by measure(s) that quantify how well the device result of a subject is associated with the clinical condition of the subject as determined by a clinical reference standard.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary