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The Maverick RNP Assay is an immunoassay for the semi-quantitative determination of anti-RNP IgG antibodies in human serum on the Maverick Diagnostic System. The presence of antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Mixed Connective Tissue Disease (MCTD).

The Maverick Diagnostic System (MDS) is an automated immunoasay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.

The Maverick Diagnostic System (MDS) is an automated immunoasay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.

I am sorry, but the provided text from the FDA 510(k) clearance letter for the Genalyte Maverick RNP Assay and Maverick Diagnostic System does not contain any information regarding the acceptance criteria, the study design, or the results of performance studies that prove the device meets these criteria.

The document primarily focuses on:

• The FDA's notification of clearance (substantial equivalence determination).
• Regulatory requirements related to the device.
• The intended use of the device (Indications for Use).
• Paperwork Reduction Act information.

Therefore, I cannot extract the specific details requested in your prompt, such as:

1. A table of acceptance criteria and 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.
5. MRMC study details and effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

To obtain this information, you would typically need to refer to the Premarket Notification (510(k)) Summary or the FDA Review Memo for K191085, which are often available on the FDA's website alongside the clearance letter. These documents provide the detailed technical information, study designs, and performance data that support the substantial equivalence determination.

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