Target condition

For diagnostic devices, a clear target condition is the starting point for choosing the reference standard and calculating sensitivity and specificity. A vague target condition makes clinical performance results hard to interpret.

The condition for which the device is to be used. In the context of diagnostic devices, a past, present, or future state of health, disease, disease stage, or any other identifiable condition within a subject; or a health condition that should prompt clinical action such as the initiation, modification or termination of treatment.

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