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The Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to verify the calibration of the Triage® Profiler S.O.B. Panel throughout the measurable range.

The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to assist the laboratory in monitoring test performance.

The Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to verify the calibration of the Triage® Profiler S.O.B. Panel throughout the measurable range.

The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to assist the laboratory in monitoring test performance.

Matrix: EDTA plasma
Form: Liquid
Analytes: CK-MB, Troponin I, Myoglobin, BNP, D-dimer
Storage: -20 °C or colder

The provided document is a 510(k) summary for Triage® Profiler S.O.B. Calibration Verification Controls / Triage® Profiler S.O.B. Controls. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance as typically seen for diagnostic algorithms.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices based on shared characteristics rather than defining specific performance acceptance criteria for the new device and then showing it met them through a study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not present in the provided 510(k) summary. The document does not describe a clinical study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not present in the provided 510(k) summary. Given that this is a quality control material and not a diagnostic device directly interpreting patient data, a "ground truth" derived from expert consensus on patient cases is not applicable in this context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not present in the provided 510(k) summary. This type of adjudication method is relevant for studies involving human interpretation of diagnostic results, not for quality control materials.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not present in the provided 510(k) summary. The device is a quality control material, not an AI or a diagnostic tool intended to assist human readers.

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

This information is not applicable and not present in the provided 510(k) summary. The device is a quality control material, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not present in the provided 510(k) summary. For quality control materials, the "ground truth" would typically refer to the known, assigned values of the analytes within the control material itself, established through robust analytical methods, rather than clinical ground truth from patient data. The document does not detail how these "true" values were established for the controls.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. The document does not describe the development or training of an algorithm using a training set.

9. How the ground truth for the training set was established

This information is not present in the provided 510(k) summary. As mentioned, the document does not describe the development or training of an algorithm.

Summary of what the document does provide regarding the study:

The document describes a submission for a quality control material, not a diagnostic device that performs analysis on patient samples. Therefore, the "study" described is a comparison to predicate devices to demonstrate substantial equivalence, rather than a performance study against clinical acceptance criteria.

The comparison focuses on:

• Intended Use: Assayed control for monitoring test performance.
• Matrix: EDTA plasma.
• Form: Liquid.
• Analytes: CK-MB, Troponin I, Myoglobin, BNP, D-dimer (for the new device) vs. CK-MB, Troponin I, Myoglobin, BNP (for the predicate). The only difference is the addition of D-dimer in the new device's analyte list.
• Storage: -20 °C or colder.

The conclusion is that the new controls are substantially equivalent to the predicate devices based on these characteristics. No specific performance data (e.g., recovery rates, precision) or acceptance criteria for these performance characteristics are provided in this summary.

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