(71 days)
For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure AST from anti-coagulated whole blood, plasma, or serum specimens to measure AST from and-coagulated with croos, pertain types of liver and heart ald in the diagnosis and treatment of patients with ouse: not for point of care or physician office laboratory use.
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Here's a breakdown of the acceptance criteria and study information for the CARESIDE™ AST device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance values. Instead, it states a "Specific equivalency claim" based on principle, intended use, and clinical performance. The study for clinical performance is a quantitative method comparison.
- Acceptance Criteria (Implicit from Specific Equivalency Claim): The CARESIDE™ AST test should be substantially equivalent in its principle, intended use, and clinical performance to the currently marketed Vitros slides for AST measurement.
- Reported Device Performance (Implicit from Method Comparison): The document indicates that a "quantitative method comparison" was performed against the Raichem Aspartate Aminotransferase method and the Sigma Diagnostics Aspartate Aminotransferase method. The results of this comparison are not explicitly tabulated or detailed in the provided text, but the conclusion of the FDA's 510(k) review is that the device is "substantially equivalent," implying the performance met the necessary criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the method comparison or the provenance (e.g., country of origin, retrospective/prospective) of the data. It only mentions that a "quantitative method comparison is provided."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided. The study is a quantitative method comparison against established reference methods (Raichem and Sigma Diagnostics methods), which serve as the "ground truth" or comparative standard. It does not involve human expert interpretation of results to establish ground truth in the same way an imaging study might.
4. Adjudication Method for the Test Set
Not applicable. As a quantitative method comparison, there isn't an "adjudication method" in the sense of reconciling differences between human expert interpretations. The comparison is against established laboratory methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI in interpretation tasks where human readers' performance is evaluated with and without AI assistance (e.g., radiology). The CARESIDE™ AST is an in vitro diagnostic device for quantitative chemical analysis, so an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, a standalone performance assessment was done. The "quantitative method comparison" evaluates the CARESIDE™ AST device (algorithm/method only) directly against established laboratory methods. It's designed to measure the analytical performance of the device itself, independent of human interpretation once the test is run.
7. The Type of Ground Truth Used
The ground truth used for the method comparison study was established by established reference methods: the Raichem Aspartate Aminotransferase method and the Sigma Diagnostics Aspartate Aminotransferase method. These methods are themselves validated laboratory procedures for measuring AST.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" sample size. For an in vitro diagnostic device like the CARESIDE™ AST, the development process might involve internal validation and optimization, but the document focuses on the clinical performance study for regulatory submission, which is typically a test or validation set comparing the device to a reference.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" information is provided related to the regulatory submission, the method for establishing its ground truth is also not detailed. Any internal development or training would likely rely on similar principles of comparing results to established laboratory methods or certified reference materials to optimize performance characteristics.
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.