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Intended for the the In Vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers. "Aspartate amino transferase (AST/SGOT) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.... " CFR 862.1100

AST (GOT) LIQUID STABLE 2 VIAL - (DST) REAGENT

This document is an FDA 510(k) clearance letter for a medical device (AST (GOT) Liquid Stable 2 Vial Reagent Incorporating DST). It is a regulatory approval document and does not contain the information requested in your prompt regarding acceptance criteria, study details, or AI performance metrics.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for the device itself beyond its intended use.
2. Sample sizes used for the test set and the data provenance: No study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No study details are provided.
4. Adjudication method for the test set: No study details are provided.
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: This device is a diagnostic reagent, not an AI system or imaging device requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used: No study details are provided.
8. The sample size for the training set: Not applicable, as this is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI algorithm.

What the document does state about the device:

• Device Name: AST (GOT) Liquid Stable 2 Vial Reagent Incorporating DST
• Indications for Use: Intended for the in vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers.
• Purpose of AST (GOT) measurements (from CFR 862.1100): Used in the diagnosis and treatment of certain types of liver and heart disease.
• Regulatory Classification: Class II
• Determination: Substantially equivalent to devices marketed prior to May 28, 1976.

To answer your prompt, you would need a clinical study report or a 510(k) summary document that typically accompanies this clearance letter, which would describe the performance characteristics and testing conducted for the device.

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