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The Triage® Protein C Test is a rapid, point-of-care fluorescence immunoassay to be used with the Triage Meters for the rapid, quantitative determination of Protein C in citrated whole blood or plasma specimens in patients with signs and symptoms of sepsis. The test is not intended for use in patients with vitamin K deficiency, DIC, cancers, HIV and liver and renal diseases as these disease conditions have not been evaluated.

The Triage Protein C Test is a single-use device containing murine monoclonal antibodies against Protein C labeled with a fluorescent dye and purified Protein C antigen immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that ensure that the test was performed properly and the reagents were functionally active. The Test Cartridge is inserted into the Triage Meter and results are measured and displayed on the display screen or printout in approximately 15 minutes. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.

The provided text describes a 510(k) summary for the Triage® Protein C Test, a rapid, point-of-care fluorescence immunoassay. However, it does not contain specific acceptance criteria (performance targets for sensitivity, specificity, accuracy, etc.) or a detailed study report that proves the device meets those criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Asserachrom® Protein C Kit) through a method comparison study. It establishes that the new device yields similar results to the predicate.

Given the information, I can extract and infer the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., "The device must achieve >90% sensitivity"). Instead, the fundamental "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to the predicate device.

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

• Sample Size for Test Set: 225 split patient samples.
• Data Provenance: The samples were collected from patients who presented with suspected or proven infection, evidence of systemic inflammation, and at least one sepsis-induced organ failure. This suggests a prospective collection within specific clinical settings (sepsis patients). The study was conducted at three independent clinical laboratory sites, but their geographical location (country of origin) is not specified.

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

This information is not provided in the document. The "ground truth" in this context is implicitly the measurement from the predicate device. Experts would typically be involved in interpreting patient conditions or establishing true disease states for diagnostic accuracy studies, which is not the primary focus here (it's a method comparison).

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are usually relevant when establishing a "ground truth" through expert consensus, especially when there's disagreement among reviewers of images or clinical data. In this method comparison study, the "truth" for comparison is the result from the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done? No, a MRMC comparative effectiveness study was not done. This study is a method comparison between the new device and a predicate device, focusing on quantitative agreement. It does not involve human readers interpreting results with and without AI assistance to assess improved effectiveness.
• Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no such study was performed.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):

• Was it done? Yes, this study effectively represents a standalone performance. The Triage Protein C Test is a fully automated immunoassay read by the Triage Meter. Its performance, as compared to the predicate device, is the standalone performance of the device and its associated meter. The study compared the quantitative output of the Triage Protein C Test directly against the predicate method on patient samples.

7. Type of Ground Truth Used:

• The "ground truth" for this method comparison study was the results obtained from the predicate device, Asserachrom® Protein C Kit (K854016). The study aimed to show that the Triage Protein C Test's measurements align with those of the legally marketed predicate device.

8. Sample Size for the Training Set:

This information is not provided. The document describes a study to validate the device's performance, but it does not mention a separate training set. For immunoassay devices, "training" (calibration curve establishment, reagent optimization) is typically part of the manufacturing and development process, rather than a distinct "training set" of patient data as might be seen for machine learning algorithms. The language used ( "manufactured reagents along with patient and quality control samples with measured Protein C values") implies the use of quality control samples which might be analogous to training data but it's not explicitly stated.

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

This information is not provided, as details about a distinct "training set" are absent. For the development and calibration of such an immunoassay, the "ground truth" would be established by reference methods or highly characterized calibrators.

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