Clinical Performance Report (CPR)

What is a Clinical Performance Report?

The Clinical Performance Report (CPR) is used to describe the ability of a device to yield results that are associated with a particular clinical condition (or a physiological process/state) in the target population when used by the intended user. How good a device is at determining who is positive with a specific clinical condition is typically based on the manufacturer’s own clinical performance studies, scientific peer-reviewed literature and published experience gained by routine diagnostic testing. Clinical performance studies shall provide documentation of the device’s diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, expected values in normal and affected populations, where applicable.