(345 days)
For the in-vitro measurement of IgA autoantibodies against B2-glycoprotein 1 (B2GP1) present in human serum. This kit may be used in conjunction with anticardiolipin assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE).
Not Found
This 510(k) summary does not contain the detailed study information required to fully answer all of your questions regarding acceptance criteria and study design. The document is primarily a notification of FDA clearance for the Bindazyme® Anti-B2 GP1 IgA EIA Test Kit, indicating that it has been deemed substantially equivalent to a legally marketed predicate device.
However, based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state acceptance criteria or detailed device performance metrics such as sensitivity, specificity, or accuracy. It primarily grants market clearance based on "substantial equivalence" to a predicate device. To get this information, one would need to review the full 510(k) submission (if available publicly) or relevant performance studies from the manufacturer.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
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 available in the provided document. Given that this is an in-vitro diagnostic (IVD) test, the ground truth would likely be established by other laboratory methods or clinical diagnoses rather than expert human interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided 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
Given that this is an in-vitro diagnostic (IVD) test kit for measuring autoantibodies in human serum, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting AI is not applicable. This type of study is relevant to image-based AI diagnostics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an "EIA Test Kit," which implies a laboratory-based immunoassay. Its performance is inherent to the kit itself, therefore, its "standalone" performance (without human-in-the-loop interpretation beyond running the assay and reading results) is what would typically be evaluated. However, specific details of this evaluation are not provided in the document.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For an in-vitro diagnostic test for autoantibodies, the ground truth would typically be established by:
- Clinical diagnosis of APS/SLE: based on established medical criteria.
- Confirmation with other validated laboratory methods: such as Western blot, indirect immunofluorescence, or other established assays for autoantibodies.
- Patient outcomes data: linked to the clinical diagnosis and presence of thrombosis.
The document does not specify which type of ground truth was used for the studies supporting its substantial equivalence. It mentions the kit aids in the diagnosis of thrombosis in at-risk patients with APS or SLE, implying the ground truth would relate to these conditions.
8. The sample size for the training set
This information is not available in the provided document. For an immunoassay kit, the concept of a "training set" is less direct than with AI algorithms. It would refer to samples used during the assay development and optimization phases.
9. How the ground truth for the training set was established
This information is not available in the provided document. Similar to point 7, it would likely involve clinically characterized samples and/or comparison to established methods.
In summary, the provided document is a regulatory approval letter and not a detailed study report. It confirms the device's market clearance but does not elaborate on the specific performance metrics, study designs, sample sizes, or ground truth establishment methods in the way a full clinical study report would.
§ 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).