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The in-vitro qualitative screening of IgA, IgG and IgM autoantibodies against cardiolipin present in human serum. It may be used in conjunction with other serological assays clinical information to aid in the diagnosis of and antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) .

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I am sorry, but without a detailed study report excerpt, I cannot provide the specific information requested about acceptance criteria and device performance. The provided text is a 510(k) clearance letter from the FDA, which confirms the device has been deemed substantially equivalent to a predicate device but does not contain the detailed study results or acceptance criteria used to support that determination.

To answer your questions, I would need a section from a study report that includes:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. Information on any MRMC comparative effectiveness study and its effect size.
6. Confirmation of whether a standalone study was done.
7. The type of ground truth used.
8. The sample size for the training set (if applicable to an AI device).
9. How the ground truth for the training set was established.

The provided document only states the device name, its indications for use, and confirms FDA clearance based on substantial equivalence. It does not include the detailed performance data or study design elements required.

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