Definitions for performance studies in the context of performance evaluations

Definitions for performance studies in the context of performance evaluations according to Section 1, Art. 2 of the EU 2017/746 IVDR are (section) in excerpts:

"Performance study": means a study to establish or confirm the analytical performance or clinical performance of a device (42)

"Clinical evidence": means clinical data and the results of performance evaluation on a device that are sufficient in quantity and quality to make a qualified judgment as to whether the device is safe and achieves the intended clinical benefit, when used as intended according to the manufacturer's claims (36)

"Clinical benefit": means the positive effects of a device related to its function, such as screening, monitoring, diagnosing, or facilitating the diagnosis of patients, or a positive impact on patient management or public health

"Performance study plan": Document describing the rationale, objectives, audit design, methodology, monitoring, statistical considerations, organization, and conduct of a performance study (43)

"Performance evaluation": means the assessment and analysis of data to establish or verify the scientific validity, analytical performance, and clinical performance, as appropriate, of a device (44)

"Interventional clinical performance study": means a clinical performance study in which test results have implications for patient management decisions and/or are used to guide treatment

Other important definitions for performance studies that are relevant to clinical evidence in the performance evaluation under Art. 56 (3):

"Performance of a device": means the ability of a device to fulfill its intended purpose as stated by the manufacturer; consisting of analytical performance and, where applicable, clinical performance to fulfill that intended purpose (39)

"Scientific validity of an analyte": Association of an analyte with a specific clinical or physiological condition (38)

"Analytical performance": means the ability of a product to correctly detect or measure a particular analyte (40). See also "sensitivity," "specificity," "positive predictive value," and negative predictive value" (49 to 53)

"Clinical performance": means the ability of a device to provide results that correlate with a specific clinical condition or physiologic or pathologic process or state in a specific target population and specific intended users (46)