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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.

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For in vitro diagnostic use with Exigent Diagnostics CareSide™ Analyzer to measure total protein from whole blood, heparinized plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

CareSide™ Total Protein cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure total protein concentration in whole blood, plasma or serum specimens. The CareSide™ Total Protein cartridge, a single use disposable in vitro diagnostic test carridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of total protein concentration. The film cartridge (patent pending) contains all reagents necessary to measure total protein concentration. When used in conjunction with the CareSide™ Albumin cartidge on the CareSide™ Analyzer, the analyzer calculates globulin (as the difference between the total protein and albumin concentrations) and the albumin/globulin ratio (A/G ratio).

Here's a summary of the acceptance criteria and study information for the CareSide™ Total Protein device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily uses the predicate device's performance characteristics or a "not provided" statement as a benchmark. For some metrics like Accuracy, Linearity, and Interference, the CareSide™ device reports its own performance without a direct comparison to a specific quantitative acceptance criterion from the predicate, implying these met general expectations for such a device. The conclusion states the device "performs as well as or better than the legally marketed predicate device."

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

Specific sample sizes for each performance characteristic (accuracy, precision, method comparison, linearity, interference studies) are not explicitly provided in the given text.

• Data Provenance: The studies appear to be clinical performance evaluations conducted by Exigent Diagnostics, Inc. The location and whether they were retrospective or prospective are not specified.

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

This information is not provided in the document. The data presented is quantitative analytical performance, presumably compared against established laboratory methods or reference values, not expert interpretation of clinical images or data.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are for analytical performance, not for subjective interpretation or agreement between multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The device is an in vitro diagnostic test for measuring total protein concentration, not a device requiring human interpretation of results in the way an imaging diagnostic device might.

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

Yes, implicitly. The reported performance characteristics (accuracy, precision, linearity, etc.) represent the performance of the CareSide™ Total Protein cartridge and CareSide™ Analyzer system as a standalone diagnostic device, without human interpretive input beyond following the operational instructions. The device directly measures and reports a quantitative result.

7. The Type of Ground Truth Used

The ground truth for the device's performance (e.g., accuracy, method comparison, linearity) would have been established using:

• Reference Methods: The "Reference Method" is stated as Biuret, which is a widely accepted laboratory method for total protein measurement.
• Predicate Device Data: For comparison, the predicate device (Vitros Total Protein DT Slides) served as a benchmark.
• Standard Calibrators/Controls: For linearity and precision studies, calibrated materials with known concentrations would have been used.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a chemical assay system with a fixed reaction sequence and measurement principle, not a machine learning or AI-based device that would typically involve a "training set" in the conventional sense of AI model development. The system uses a "lot-specific standard curve" for calculation, which implies calibration data for each lot, but this is distinct from training a machine learning model.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/not provided for the same reasons as point 8. The device operates based on established chemical reactions and calibration curves rather than an AI training process.

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