(24 days)
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum. The results from this assay can be used as an aid in the diagnosis of autoimmune diseases.
This is an enzyme immunoassay for the detection of antibodies to extractable nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum.
Here's an analysis of the provided text to extract the requested information about device acceptance criteria and the supporting study:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are not explicitly stated as distinct criteria, but rather are inferred from the performance metrics (sensitivity, specificity, and overall agreement) presented to demonstrate substantial equivalence to a predicate device. The performance is reported in relation to the predicate device.
| Performance Metric | Acceptance Criteria (Inferred from equivalence claim) | Reported Device Performance (RELISA® ENA Single Well Screen) |
|---|---|---|
| Relative Sensitivity | High (to show equivalence with predicate) | 97.9% |
| Relative Specificity | High (to show equivalence with predicate) | 97.8% |
| Overall Agreement | High (to show equivalence with predicate) | 97.8% |
2. Sample size used for the test set and the data provenance
- Test set sample size:
- The table indicates the total number of samples tested by referring to the "Immuno Concepts RELISA® Multiparameter ENA Screening Test" as the reference method.
- Total samples = 126 (Positive) + 9 (Positive) + 5 (Positive) + 0 (Borderline) + 2 (Borderline) + 4 (Borderline) + 1 (Negative) + 2 (Negative) + 394 (Negative) = 543 samples
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the text. The "ground truth" or reference method for comparison is the "Immuno Concepts RELISA® Multiparameter ENA Screening Assay (K935129)," which is another diagnostic test, not expert opinion.
4. Adjudication method for the test set
- This information is not applicable/provided. The "ground truth" was established by a predicate diagnostic device, not by human experts requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not an MRMC study. The device is an in vitro diagnostic test (enzyme immunoassay) for detecting antibodies, not an AI system for image interpretation or diagnosis by human readers. Therefore, this question is not relevant to the provided study description.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this study is inherently a standalone performance evaluation of the RELISA® ENA Single Well Screen Antibody Test System. It compares the device's results directly against a predicate diagnostic device without human interpretation as part of the primary measurement.
7. The type of ground truth used
- The "ground truth" (or reference standard in this context) used was the Immuno Concepts RELISA® Multiparameter ENA Screening Assay (K935129). This is a previously cleared, legally marketed diagnostic device.
8. The sample size for the training set
- The text does not provide information on a training set. This study describes a performance comparison of a final device against a predicate, which aligns with verification/validation testing rather than a description of the model development phase.
9. How the ground truth for the training set was established
- As there's no mention of a training set, this information is not applicable/provided.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).