Performance Evaluation Report
Performance Evaluation Report – An Overview
The objective of performance evaluation is to review and analyse data in order to satisfy the manufacturer’s stated purpose for IVD. Clinical performance studies are also required by the IVDR to establish or confirm the performance features of an in vitro diagnostic medical device if analytical performance studies or scientific literature cannot properly substantiate them.
Plan and report make up the performance evaluation. The following is a summary of the details.
Performance Evaluation Plan
- The device’s intended purpose.
- Product features are described in detail.
- The analyte or marker that the product should detect is specified.
- Details about the IVD’s indications, contraindications, and target patient categories.
- The utilisation of reference materials and IVD measurement procedures ensures metrological traceability.
- Scientific data is used to support the general safety and performance criteria.
- The Manufacturer’s statistical techniques for evaluating and analysing clinical performance, limits, and information given for IVD.
- Current norms and recommendations are referred to.
- Provide a risk-benefit ratio for current medical research and clinical performance, as well as an analysis of it.
- The identification and specification of reference databases or published papers provide a basis for decision-making for devices categorized as software.
- The life cycle of in vitro diagnostic medical device product development, including proof of validity and clinical performance.
- Part B of Annex XIII of the IVDR defines post-market performance follow-up (PMPF).
Performance Evaluation Report
This report shall include at least the following points:
- Methods for evaluating clinical evidence are described in detail.
- The IVD’s purpose and categorization, as well as the explanation for safety and performance qualities, are all necessary.
- By way of protocol and report, information on the systematic search, selection, assessment, analysis, and conclusions of the scientific literature on the in vitro diagnostic medical device under review, including verification of the validity and evidence of the publications utilised.
- Part B of Annex XIII of the IVDR defines the post-market performance follow-up results.
- Classification of the most recent scientific results of the in vitro diagnostic medical device’s needed performance parameters
How To Conduct Performance Evaluation
Steps involved in conducting Performance Evaluation.
- Scientific validity
IVD is the analyte used to detect a physiological state or illness, and it entails monitoring the same analyte or marker. This can be accomplished by a literature search and, if necessary, proof of pre-clinical research or clinical performance. Annex XIII, Part A is a good place to start.
- Analytical performance
This entails determining the IVD’s performance characteristics. Sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (coming from trueness and precision), detection and quantification limits, measurement range, and linearity are some of them. The Analytical Performance Report will describe the results of the analytical performance evaluation.
- Clinical performance:
This entails determining your device’s diagnostic accuracy. Diagnostic sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio, and anticipated values in normal and afflicted populations are among them.