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The Antiphospholipid Syndrome is a clinical diagnosis supported by finding a positive antiphospholipid ELISA and/or lupus anticoagulant test. Indications for the test include: patients with unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained occlusion of the arterial circulation resulting in stroke, myocardial infarction, or peripheral gangrene. In patients with unexplained venous thrombosis, other disorder should be excluded, such as protein C, S, or antithrombin III deficiency, as well as malignancy or the nephrotic syndrome. The test is also indicated in women with one or more unexplained second or third trimester pregnancy losses or two or more first trimester losses. Finally, patients with unexplained thrombocytopenia as well as other abnormalities said to be associated with the Antiphospholipid Syndrome should be tested.

The APL® IgA ELISA Kit is a semiquantitative enzyme linked immunosorben assay (ELISA) for use as an aid in diagnosing the Antiphospholipid Syndrome (APS) in patients presenting with thrombosis, pregnancy losses and/or thrombocytopenia. It enables measurement of IgA anticardiolpin antibody levels in human serum.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the APL® IgA ELISA Kit. It approves the device but does not contain the acceptance criteria, reported device performance, details of the study, or information about ground truth establishment.

Therefore, I cannot fulfill the request as the necessary information is not present in the given text.

The provided document is an FDA approval letter for a 510(k) premarket notification. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a scientific clinical report or a device's summary of safety and effectiveness.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sized used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: This information is not present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document primarily focuses on the FDA's determination of substantial equivalence for the APL® IgA ELISA Kit to legally marketed predicate devices, and its intended use for aiding in the diagnosis of Antiphospholipid Syndrome (APS).

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The aCL/aPS®FACS Kit is and assay for the semi-quantitative determination of antiphospholipid (anticardiolipin-aCL and antiphosphatidy/serine-aPS) antibodies to be used in the aid of the diagnosis of the Antiphospholipid Syndrome (APS). APS is defined as a disorder of recurrent thrombosis, pregnancy loss and/or thrombocytopenia with persistent positive antiphospholipid tests.

ACL/aPS FACS Kit

This document is a marketing clearance letter from the FDA for the ACL/APS FACS Kit. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory requirements and provides contact information for various FDA offices.

To provide the requested information, I would need to analyze a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission itself, if available.

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