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The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the assessment and evaluation of patients suspected of disseminated intravascular coagulation (including pulmonary embolism) and other non-specific thromboembolic events, and an aid in the risk stratification of patients with acute coronary syndromes.

The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens.

The provided document focuses on the Triage® Profiler S.O.B. Panel, a fluorescence immunoassay device. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, the document does not contain acceptance criteria, detailed study results, or information typically found in a clinical performance study report (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone performance metrics like sensitivity/specificity).

Instead, the document is a 510(k) Summary of Safety and Effectiveness, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This type of submission relies heavily on comparisons to existing, approved devices rather than comprehensive de novo clinical trials establishing performance against predefined statistical criteria.

Therefore, the requested information (acceptance criteria, specific performance metrics, sample sizes, ground truth details, etc.) cannot be extracted from this document because it is not included.

The document primarily states:

• "A method comparison of the CK-MB, troponin I, myoglobin, and BNP assays demonstrated that the assays on the Triage Profiler S.O.B. panel are equivalent to the same assays in the predicate methods."
• "A method comparison of D-dimer results was performed using 180 specimens throughout the measurable range of the test. A Passing-Bablok regression analysis of the results yielded a linear relationship with a slope of 0.999, an intercept of -85.89 and a correlation coefficient of 0.92."
• "The analytical performance characteristics for each of the assays were equivalent with the predicate methods."

This indicates that the "study" was primarily a method comparison study against existing, approved devices/methods, not a clinical study to establish performance against defined acceptance criteria for diagnostic accuracy, sensitivity, or specificity.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a summary of what can be inferred or directly stated from the document regarding the "study" conducted:

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

2. Sample size(s) used for the test set and the data provenance

• Sample Size for D-dimer comparison: 180 specimens.
• Sample Size for other assays (CK-MB, Troponin I, Myoglobin, BNP): Not explicitly stated, described generally as "a method comparison."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It is likely laboratory-based analytical data rather than patient-level clinical data from a specific geographical region.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. The "ground truth" for a method comparison study relies on the results of the predicate (established, approved) devices/methods. The document does not mention human expert interpretation for establishing ground truth for the device's measurements.

4. Adjudication method for the test set

• Not applicable/Not provided. This type of method comparison does not typically involve human adjudication of results in the way a diagnostic imaging study might. The comparison is between the new device's quantitative outputs and the predicate device's quantitative outputs.

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

• Not applicable. This is not an AI-based device, nor is it a multi-reader, multi-case study as typically understood in diagnostic imaging or complex interpretation tasks. It is an in vitro diagnostic (IVD) assay quantifying biomarkers.

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

• The study described is inherently "standalone" in principle, as it evaluates the device's analytical performance in generating quantitative results. There is no "human-in-the-loop" aspect described for the measurement itself, beyond potentially a lab technician operating the device. The reported performance refers to the device's output compared to predicate devices.

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

• The "ground truth" was established by the predicate devices' quantitative results. The comparison aimed to show that the Triage® Profiler S.O.B. Panel's measurements align with those of already approved and marketed devices (Triage® Cardiac Panel, Triage® BNP Test, Dade Behring Stratus CS DDMR TestPak).

8. The sample size for the training set

• Not applicable/Not provided. This is a 510(k) submission for a new immunoassay, not a machine learning or AI algorithm that requires a separate "training set" in the computational sense. The "training" of such a device is typically done during its development and calibration phases, not as a distinct "training set" sample size reported in the context of a 510(k) comparison study.

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

• Not applicable/Not provided, for the same reasons as point 8.

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