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The Triage® Cardio ProfilER is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB. myoglobin, troponin I, and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification of patients with acute coronary syndromes.

The Triage® Cardiac Panel is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB, myoglobin and troponin I in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnesis of myocardial infarction (injury).

Device Description

The Triage® Cardio ProfilER is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB, myoqlobin, troponin I, and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification of patients with acute coronary syndromes.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in the traditional sense of a clinical trial with performance metrics.

Instead, the document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo performance criteria through a new clinical effectiveness study.

The primary "study" mentioned is the comparison data used to show substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no explicit acceptance criteria or detailed performance metrics are provided in this 510(k) summary. The document asserts substantial equivalence to predicate devices.

Acceptance Criteria (Not Explicitly Stated, Implied Equivalence to Predicates)	Reported Device Performance (Summary of Comparison Data)
Analytical sensitivity of troponin assay equivalent to or better than predicate.	Troponin assay has a lower analytical sensitivity than the troponin assay on the Triage® Cardiac Panel (predicate).
Compatibility with EDTA anticoagulant.	Triage® Cardio ProfilER uses EDTA as an anticoagulant (predicate used heparin).
Overall performance (diagnosis of MI, CHF, risk stratification) equivalent to predicate devices.	The design control process led to a determination that the Triage® Cardio ProfilER and Triage® Cardiac Panel are substantially equivalent to the previously cleared predicate devices.

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

Sample Size: Not specified.
Data Provenance: Not specified. The document only refers to "comparison data" without detailing its origin or nature (e.g., patient samples, spiked samples, retrospective vs. prospective).

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

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

Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned or implied. The focus is on demonstrating analytical (and likely clinical, through equivalence) performance of the device itself, not on how human readers would perform with or without AI assistance.

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

Was a standalone study done? The document describes the device as a "fluorescence immunoassay to be used with the Triage® Meter." This implies a standalone performance of the analytical system (immunoassay + meter) is being evaluated for its quantitative determination of biomarkers. However, the details of such a study (e.g., accuracy, precision, limits of detection) are not included in this summary. The 510(k) summary focuses on the comparison to predicates.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For an immunoassay, the "ground truth" would typically be established by reference methods or laboratory standards for the concentrations of the biomarkers (Creatine Kinase MB, myoglobin, troponin I, BNP). Given the context of a 510(k) summary for substantial equivalence, clinical ground truth (e.g., pathology, outcomes data) for diagnosis of MI or CHF is not described as being established directly for this specific device's performance study; instead, its intended use is tied to its ability to accurately measure biomarkers, which then aids in diagnosis.

8. Sample Size for the Training Set

Sample Size: Not applicable/Not specified. This device is an immunoassay, not a machine learning or AI algorithm that typically has a "training set" in the conventional sense. The "training" of such a device involves assay development, calibration, and optimization using manufacturing and quality control standards.

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

How Ground Truth Was Established: Not applicable/Not specified, as it's not a machine learning model. For a diagnostic immunoassay, "ground truth" during development involves using highly characterized reference materials, calibrators, and known-concentration samples to ensure the assay's accuracy and precision across its measuring range.

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