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Sigma Diagnostics INFINITY™ AST Reagent is intended for the in vitro quantitative determination of AST (Aspartate Aminotransferase EC2.6.1.1) in human serum on both automated and manual systems.

Sigma Diagnostics INFINITY™ AST Reagent is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

The Sigma Diagnostics INFINITY AST Reagent is based on the recommendations of the IFCC. The series of reactions involved in the assay system is as follows:

• AST present in the sample catalyzes the transfer of the amino group from L-aspartate to 2-1 . oxoglutarate forming oxaloacetate and L-glutamate.
• Oxaloacetate in the presence of NADH and Malate dehydrogenase (MDH), is reduced to 2. L-malate. In this reaction NADH is oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.
• Addition of Lactate dehydrogenase (LDH) to the reagent is necessary to achieve rapid and 3. complete reduction of endogenous pyruvate so that it does not interfere with the assay.

The provided text is a 510(k) summary and FDA clearance letter for an in vitro diagnostic reagent, the Sigma Diagnostics INFINITY™ AST Reagent. This type of device is a chemical reagent used in laboratory tests and does not involve AI or algorithms in the way typically discussed for medical imaging or other diagnostic tools.

Therefore, many of the requested bullet points, such as those related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or specific ground truth methods for AI models, are not applicable to this type of device.

This document describes the intended use and substantial equivalence to a predicate device, rather than a study demonstrating meeting specific performance criteria in the context of an AI/ML device.

However, I can extract information relevant to the device's characteristics and the basis for its clearance:

1. Table of acceptance criteria and the reported device performance

The provided document does not explicitly state quantitative "acceptance criteria" for performance metrics in a table. Instead, it asserts substantial equivalence to a predicate device, meaning its performance is considered comparable and acceptable based on the predicate's established performance.

• Acceptance Criteria (Implied by Substantial Equivalence): The device's performance characteristics (e.g., accuracy, precision, linearity, analytical measurement range) are deemed equivalent to the legally marketed predicate device (TRACE Scientific AST (DST) Reagent Kit, K961114). The specific quantitative criteria met by the predicate are not detailed in this summary.
• Reported Device Performance: The document states, "The Sigma Diagnostics INFINITY™ AST Reagent Kit (Procedure No. 51-uv) is substantially equivalent to, and is the same product as the TRACE Scientific AST (DST) Reagent Kit cleared by FDA as K961114." This statement is the reported performance, indicating that it performs identically to an already-cleared device. No independent performance data for the INFINITY™ AST Reagent is provided beyond this claim of equivalence.

2. Sample size used for the test set and the data provenance

Not applicable as this is a reagent and not an AI/ML device requiring a test set for performance evaluation in the context of an algorithm. The basis for clearance is substantial equivalence to an existing product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This is an IVD reagent, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a chemical reagent.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For an IVD reagent, "ground truth" typically refers to the accuracy of its analytical measurement against a reference method or known concentration standards, but these details are not provided in this summary. The substantial equivalence claim suggests that the analytical performance matches the predicate.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML model to train.

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