The Performance Evaluation Report outlines the methodologies and outcomes concerning the scientific validity, analytical performance, and clinical performance.
A dedicated standard for this is EN 13612:2002, which is concise and does not contain extensive details. Additionally, there are three IMDRF guidance documents:
Product Details
- Name: \
- Version: \
- Basic UDI-DI: \
Requirement Mapping to Document Sections
| EN 13612:2002 Section | Document | Section |
|---|---|---|
| 3.1 Responsibilities and Resources | Performance Evaluation Plan | |
| 3.2 Documentation | Performance Evaluation Plan | |
| 3.3 Final Assessment and Review | Performance Evaluation Report (this one) | 10 |
| 4.1 Preconditions | Performance Evaluation Report (this one) | 7, 8, 9 |
| 4.2 Evaluation Plan | Performance Evaluation Plan | |
| 4.3 Sites and Resources | Performance Evaluation Plan | |
| 4.4 Basic Design Information | Performance Evaluation Plan | |
| 4.5 Experimental Design | Performance Evaluation Plan | |
| 4.6 Performance Study Records | Performance Evaluation Plan | |
| 4.7 Observations and Unexpected Outcomes | Performance Evaluation Plan | |
| 4.8 Evaluation Report | Performance Evaluation Report (this one) | (all) |
| 5. Modifications During the Performance Evaluation Study | Performance Evaluation Plan | |
| 6. Re-evaluation | Performance Evaluation Plan | |
| 7. Protection and Safety of Probands | Performance Evaluation Plan |
1. List of Abbreviations
| Abbreviation | Explanation |
|---|---|
| IVD MD | In-vitro diagnostic medical device |
2. Product Details
- Name: \
- Version: \
- Basic UDI-DI: \
- UMDNS-Code:
- GMDN-Code:
3. Associated Documents
- SOP Performance Evaluation
- Performance Evaluation Plan
4. Intended Use
Include the intended use of your device here.
5. Risk Analysis
Provide the summary of your Risk Analysis Report here.
6. Medical Context and Current Practices
6.1 Medical Context
Provide an overview of the medical context in which the IVD is applied. For example, if it is an HIV test, indicate if it is used for screening or for individuals who suspect recent HIV exposure.
6.2 State of the Art
Explain the current methods used for diagnosing or managing the relevant condition. For instance, if discussing an HIV test, describe what is done for individuals screened for HIV or those who believe they may have been recently infected. Mention if specific diagnostic tests or other procedures, like a chest X-ray, are typically used.
7. Scientific Validity
This section typically relies on literature research. The scientific basis for the IVD’s measurements should be supported by current evidence linking those measurements to relevant conditions.
Example: For an HIV test, the rationale for testing is rooted in scientific evidence indicating that early detection of HIV is crucial since untreated HIV progresses to AIDS. Early diagnosis enables timely treatment and improved outcomes, making it scientifically valid to conduct HIV testing.
7.1 Scientific Validity: Literature Search Methods
Detail the methodology for conducting literature research to establish scientific validity. Include key terms used and the sources consulted, such as:
- Bibliographic databases (e.g., MEDLINE, EMBASE)
- Specialized databases (e.g., MEDION)
- Systematic review databases (e.g., Cochrane Collaboration)
- Clinical trial registries (e.g., CENTRAL, NIH)
- Adverse event report databases (e.g., MAUDE, IRIS)
- Reference texts
7.2 Scientific Validity: Literature Search Results
Present findings from your literature search in detail:
| Database | Search term | # Hits | # Evaluated Abstracts | # Potential Relevant Publications |
|---|---|---|---|---|
| Database | Title | Author | Year | Summary | Relevant? Why? |
|---|---|---|---|---|---|
7.3 Scientific Validity: Literature Search Conclusion
Summarize the findings of your literature research, similar to a “discussion” section in a research paper. For instance, in the case of an HIV test, the conclusion might emphasize the value of HIV testing for early detection and subsequent treatment.
8. Analytical Performance
Explain the key metrics that illustrate how the IVD detects the intended analytes.
For example, in an HIV test, metrics like sensitivity and specificity should be outlined: what would be expected if the test were applied to 100 blood samples from various patients?
This requires performing the test on a sample set and analyzing the data.
8.1 Analytical Performance: Methods
Outline the methods used for analyzing analytical performance, including any details about datasets if a Machine Learning model is involved, as well as metrics used for evaluation.
8.2 Analytical Performance: Results
Present the results from your analytical performance analysis, following a structure similar to that used in peer-reviewed studies.
9. Clinical Performance
Clinical performance is more complex than scientific validity, focusing on the device’s metrics in the target patient group.
For an HIV test, analytical performance may provide data at the “reagent” level, but clinical performance indicates how the test performs with actual patients, taking into account potential real-world complications like coexisting diseases that could cause false positives.
9.1 Clinical Performance: Methods
Describe the methods for evaluating clinical performance.
9.2 Clinical Performance: Results
Present the clinical performance results.
10. Conclusion
Summarize why the IVD is considered safe and effective. Reference the intended use, risk analysis, scientific validity, analytical performance, and clinical performance as supportive elements.
11. Dates and Signatures
Provide the date and sign the document. Digital signatures can be added if your document management system permits, or you can use the traditional method of signing a printed copy.
| Activity | Name | Signature |
|---|---|---|
| Creation | ||
| Review | ||
| Approval |
12. Qualification of Evaluators
Attach the CVs of the individuals who contributed to the preparation of the Performance Evaluation, ensuring they have the necessary expertise and training.