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The Aspartate Aminotransferase (AST) assay is used for the quantitation of aspartate aminotransferase in human serum or plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Aspartate Aminotransferase is an in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma. The Aspartate Aminotransferase assay is a clinical chemistry assay. Lactate dehydrogenase (LD) is added to prevent interference from endogenous a-keto acids. Aspartate aminotransferase in the sample catalyzes the transfer of the amino group from aspartate to x-ketogluterate to form oxalacetate and glutamate. The oxalacetate formed is reduced to malate in the presence of malate dehydrogenase (MD) with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). The resulting rate of decrease in absorbance at 340 nm is proportional to the AST activity in the sample.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aspartate Aminotransferase (AST) assay, structured according to your request:

Acceptance Criteria and Device Performance

This submission describes a substantial equivalence claim for an in vitro diagnostic device, meaning the new device (Abbott Laboratories AST assay) is being compared to a legally marketed predicate device (Roche® Cobas Mira® Plus Automated Chemistry System Aspartate Aminotransferase assay). Therefore, the "acceptance criteria" are implied by the performance of the predicate device, and the new device aims to demonstrate "similar performance characteristics."

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document mentions "Comparative performance studies were conducted" and "Precision studies were conducted using two levels of control material." However, the exact number of patient samples or replicates used for these studies is not provided.
• Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data nor whether the study was retrospective or prospective. Given it's a 510(k) summary for an in vitro diagnostic device, the data are almost certainly clinical samples, but details are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. For an in vitro diagnostic assay like this (quantifying an analyte in biological fluid), "ground truth" is typically established by analytical methods rather than expert consensus on interpretation. The comparator method (Roche Cobas Mira Plus Automated Chemistry System Aspartate Aminotransferase assay) serves as the reference for comparison. The performance of the predicate device would have been established through its own validation studies.

4. Adjudication Method for the Test Set:

• Not Applicable. Since this is an analytical performance study comparing two quantitative methods, adjudication by human experts is not relevant. The assessment relies on statistical correlation and precision measures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

• No. An MRMC study is typically performed for image-based diagnostic devices where multiple human readers interpret cases. This submission is for an in vitro diagnostic assay, where the output is a quantitative value, not subject to human interpretation in the same way.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, effectively. This is a standalone performance study. The AST assay itself is an automated chemical reaction and measurement system. Its performance (correlation with predicate, precision, linearity, sensitivity) is reported based on the algorithm/method itself, without human intervention in the result generation or interpretation for the purpose of this performance study. The device quantifies AST, and the reading is directly from the instrument.

7. The Type of Ground Truth Used:

• Comparability to a Reference Method. The "ground truth" for assessing the new device's accuracy is its comparison to the Roche Cobas Mira Plus Automated Chemistry System Aspartate Aminotransferase assay (the legally marketed predicate device). The assumption is that the predicate device provides accurate AST measurements.

8. The Sample Size for the Training Set:

• Not applicable/Not explicitly mentioned. For a traditional chemical assay like this, there isn't a "training set" in the sense of machine learning algorithms. The assay development process involves optimization and calibration using various reagents and known standards, but this is distinct from "training data" for an AI model.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/Not explicitly mentioned. As noted in point 8, the concept of a "training set" and establishing "ground truth" for it doesn't directly apply in the same way to this type of chemical assay as it would to a machine learning device. Assay parameters are typically established through chemical principles, calibration with known standards, and optimization experiments. The document describes the chemical reaction and how the measurement is made.

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