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The Triage® Total 3 Controls are assayed controls to be used with the Triage® Troponin I Test. Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

The Triage® Total 3 Controls and the Triage® Total 3 Calibration Verification Set are quality control materials that contain CKMB, cardiac troponin I, and BNP at multiple concentrations. These materials are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage® tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient.

This submission describes Triage® Total 3 Controls and Triage® Total 3 Calibration Verification Set, which are assayed quality control materials used to monitor the performance of specific Triage® tests (Troponin I, BNP, Cardio2 Panel, Cardio3 Panel) and the Triage® Meter. The device is being compared to a predicate device, the Triage® Total 5 Controls and Calibration Verification Set.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the new device. Instead, it relies on demonstrating "substantial equivalence" to a predicate device through "performance testing." The key performance characteristic mentioned is "value assignment and stability."

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

The document does not provide specific details on the sample size used for the performance testing. It generally refers to "bench performance testing."

It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). Given that it's a Triage® product, the test is likely performed in clinical laboratories, which could be in the US or other regions where Triage® products are used. The testing described appears to be laboratory-based ("bench performance testing") rather than patient-based.

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

Given that this device is a quality control material, the concept of "ground truth" derived from expert consensus on patient data (e.g., radiologists interpreting images) is not applicable. The "ground truth" in this context would be the accurately determined concentrations of the analytes (CKMB, cardiac troponin I, and BNP) within the control materials. These values are established through rigorous analytical methods and reference standards, not human expert consensus. The document does not specify the number or qualifications of experts involved in this process, as it falls under standard quality control manufacturing practices.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for quality control materials is established through analytical validation and reference methods, not human adjudication.

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

No. This is a quality control material for in vitro diagnostic tests, not an AI or imaging device that would involve human readers. Therefore, an MRMC study is not relevant.

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

Yes. The performance testing described (value assignment and stability) represents standalone performance of the control materials in conjunction with the Triage® meter/assays, without direct human intervention in the "performance" aspect itself beyond standard laboratory procedures for running controls. The device's function is to objectively monitor the performance of other diagnostic tests.

7. Type of Ground Truth Used

The "ground truth" for this type of device would be the analytically determined concentrations of the target analytes (CKMB, cardiac troponin I, and BNP) within the control materials, established through validated reference methods and traceable standards. The document doesn't explicitly detail the methodology for establishing these values but implies they are part of the "value assignment" process.

8. Sample Size for the Training Set

Not applicable. This device is a quality control material and not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of such a device involves the manufacturing process and analytical validation.

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

Not applicable, as there is no "training set" for this type of device. The "ground truth" (i.e., the target values) for such quality control materials are established during their development and manufacturing through precise analytical methods.

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