(29 days)
The Varelisa Cardiolipin Antibodies Screen EIA kit is designed for the qualitative determination of antibodies against cardiolivin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).
The Varelisa Cardiolipin Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against cardiolipin in serum or plasma.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or accuracy percentages). Instead, the study focuses on demonstrating substantial equivalence to a predicate device and showing the assay "performs as expected from the medical literature."
The "reported device performance" is described in terms of its comparability to the original/predicate device.
| Acceptance Criteria (Implied) | Reported (New Device) Performance |
|---|---|
| Substantial equivalence to predicate device | Data supports substantial equivalence to the predicate/original device. |
| Performs as expected from medical literature | Data shows the assay performs as expected from the medical literature. |
| Comparability across positive, equivocal, and negative sera | Results obtained within a comparison study analyzing positive, equivocal, and negative sera. (No specific numerical results provided, but the study implies they were comparable enough to support equivalence). |
| Comparability with externally defined Calibrators | Results obtained for externally defined Calibrators. (No specific numerical results provided, but the study implies they were comparable enough to support equivalence). |
| Performance with samples from apparently healthy subjects (normal population) | Results obtained for samples from apparently healthy subjects (normal population). (No specific numerical results provided, but the study implies they were comparable enough to support equivalence). |
| Intended Use reflects current scientific knowledge | The intended use was adapted to the current state of scientific knowledge, reflecting the diagnostic relevance of anti-cardiolipin antibodies in antiphospholipid syndrome (APS) and thrombotic risk in SLE. (This is a design criterion rather than a performance metric, but it is a key aspect of the "new" device's justification). |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text does not provide specific sample sizes for the "test set." It mentions data from:
- "a comparison study analyzing positive, equivocal and negative sera."
- "externally defined Calibrators."
- "samples from apparently healthy subjects (normal population)."
The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated. The manufacturer is based in Germany, so it's plausible the data originated from there or other European countries, but this is not confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The text does not describe how ground truth was established for the comparison studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data. The study focuses on the analytical performance of the assay itself compared to a previous version.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense, a "standalone" performance evaluation was done as this is an IVD device. The study evaluates the performance of the modified Varelisa® Cardiolipin Antibodies Screen assay as a standalone diagnostic tool, comparing it to its predicate version and its expected performance based on medical literature. Human intervention (other than laboratory procedures) in the interpretation of the assay result for diagnosis is inherent in the clinical use of such tests, but the submitted study evaluated the device's technical performance directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "ground truth" used for the comparison study. Given that it's a diagnostic test for antibodies, the ground truth would typically be established through:
- Clinical diagnosis of APS/SLE: For the "positive" and "negative" sera, this would likely involve a clinical diagnosis by physicians based on established criteria and other laboratory findings, or
- Reference laboratory methods: Comparison against a gold-standard or highly validated reference method for cardiolipin antibodies.
- Expert consensus: In some cases, expert panels might classify samples.
The text mentions "externally defined Calibrators," which would have their values established by a reference method.
8. The sample size for the training set
This information is not provided. Since this is an immunoassay and not a machine learning model, there isn't a "training set" in the typical AI/ML sense. The development of the assay, including optimizing the antigen supplier and blocking procedure, would have involved internal validation and optimization studies, but these are not described as a "training set" with specific sample sizes.
9. How the ground truth for the training set was established
As there is no "training set" in the AI/ML context, this question is not applicable. For the development and optimization of the immunoassay, the "ground truth" would have come from established concentrations of analytes, known positive/negative samples, and comparison to existing validated methods during the assay development process. However, the details of these are not provided.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).