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The Triage Protein C Controls are assayed materials to be used with the Triage Protein C. Test to assist the laboratory in monitoring test performance.

The Triage Protein C Calibration Verification Controls may be used by the laboratory to validate the performance of the Triage Protein C Test throughout the measurable range of the assay.

The Triage Protein C Control 1 and Control 2. and the Triage Protein C Calibration Verification Control Levels A, B and C are single-use, 0.25 mL unit dose liquid external quality control materials prepared with concentrated purified Protein C in human citrated plasma at defined levels. The controls are stored frozen at

Here's a breakdown of the acceptance criteria and the study details for the Triage Protein C Test controls, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided text for the Triage Protein C Test controls does not explicitly state numerical acceptance criteria for precision or accuracy. Instead, it uses qualitative descriptors for performance.

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

• Test Set Sample Size: 240 coded samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "three different sites," which suggests a multi-center study, but it doesn’t specify if these were in the US or other countries. The study appears to be prospective as it describes the evaluation of the controls.

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

This information is not provided in the document. For quality control materials, the "ground truth" (expected values) is typically established through a rigorous process of assaying the control material using a reference method or multiple validated methods, often involving independent laboratories or highly calibrated instruments. The document refers to "expected values" but doesn't detail how these were established or if experts were involved in setting them.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are typically relevant for studies where a "true" diagnosis or classification needs to be resolved among multiple interpretations (e.g., by different readers). For a study evaluating controls against "expected values," a formal adjudication method as described (e.g., 2+1, 3+1) is less applicable. The "expected values" themselves serve as the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This study is for quality control materials for an instrument, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not relevant to this submission.

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

• No, this is not applicable. The device is a set of control materials used with an assay (the Triage Protein C Test), not an algorithm or an AI system. The study evaluates the performance of these control materials in monitoring the assay's performance.

7. The Type of Ground Truth Used

• The ground truth used was based on "expected values" for protein C concentrations in the control materials. How these "expected values" were precisely determined (e.g., against a reference standard, by a consensus of multiple validated assays, or pathology results) is not explicitly detailed beyond the mention of prepared materials 'at defined levels'. It's implied that these 'defined levels' are the reference.

8. The Sample Size for the Training Set

• This information is not applicable as the device is a control material, not an algorithm or AI model that requires a training set.

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

• This information is not applicable for the same reason as in point 8.

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