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The Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software is intended to measure fluorescence signals of labeled DNA and RNA target hybridized to GeneChip® arrays.

Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance. The document is a 510(k) clearance letter from the FDA for a medical device ("Affymetrix Genechip Microarray Instrumentation System"), indicating that the device has been deemed substantially equivalent to a predicate device.

While it mentions the device name, regulation number, and product code, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for an AI model.
• Information on expert reviews, adjudication methods, or MRMC studies.
• Any discussion of standalone algorithm performance.

The document is purely a regulatory clearance notice and does not contain the technical study data you are asking for.

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