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The CARDIAC D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the CARDIAC Reader instrument.

D-Dimer is a degradation product of crosslinked firbrin. The d-dimer concentration is a measure of the fibrinolytic activity of plasmin in the vascular system. Elevated concentrations of d-dimer indicate increased coagulatory and fibrinolytic activity. In general, a validated d-dimer assay may be useful in ruling out deep venous thrombosis or pulmonary embolism.

The Cardiac D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the Cardiac Reader Instrument.

The test is based on the dual monoclonal antibody "sandwich" principle using a poly-(streptavidin)-biotin capture system with a gold sol particle label. The test is initiated by the addition of whole blood to the Cardiac D-Dimer Assay, which separates red blood cells from plasma. D-Dimer in plasma combines with both biotinylated anti-d-dimer antibody conjugated to gold sol particles, to form a "sandwich". This "sandwich" combines with poly-(streptavidin), which is immobilized in a stripe or line across the read window of the Cardiac D-Dimer Assay, producing a reddish purple line. The intensity and speed at which the color forms are related to the concentration of d-dimer in the blood.

Here's an analysis of the provided text regarding the Cardiac D-Dimer Assay and its acceptance criteria, structured according to your request.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device and its intended use but does not explicitly state specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy thresholds) for its performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

The reported device performance is described through its measurement range and how results are displayed.

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

The provided 510(k) summary does not include information about the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective study design). It describes the device, its intended use, and its similarities/differences to a predicate device for the purpose of demonstrating substantial equivalence. Clinical study data, including sample sizes and origins, are typically found in the full 510(k) submission, not just the summary.

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

This information is not provided in the 510(k) summary. Given that this is an in-vitro diagnostic device for D-Dimer levels, the "ground truth" would likely be established by a reference method or predicate device rather than expert consensus on images or clinical assessments.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reviewing images), which is not explicitly described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not provided in the 510(k) summary. MRMC studies are primarily for evaluating AI's impact on human reader performance, usually in imaging diagnostics. This document describes an in-vitro diagnostic assay, not an imaging AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself, the "Cardiac D-Dimer Assay," is an in-vitro diagnostic device that provides a quantitative or semi-quantitative output. It is a standalone algorithm/device in the sense that its output is a direct measurement of D-Dimer. It's not an AI system that provides interpretations that a human then uses to make a decision, but rather a diagnostic test whose result directly informs clinical decision-making. No "human-in-the-loop" performance is described for the assay itself, as its function is to measure a biomarker.

7. The Type of Ground Truth Used

Based on the nature of the device (a quantitative D-Dimer assay), the ground truth for evaluating its performance would typically involve:

• Reference Method Comparison: Comparing the device's results against a well-established, more accurate reference method (e.g., a gold standard laboratory D-Dimer assay).
• Predicate Device Comparison: As shown in the summary, substantial equivalence is claimed against the Roche Diagnostics Tina-quant® D-Dimer Test System (K002706). This implies that the performance of the new device was compared to the predicate device, using the predicate's results as a de facto "ground truth" for demonstrating similar performance characteristics.

The specific "type of ground truth" used for validation studies leading to the 510(k) is not detailed, but it would almost certainly be based on laboratory analytical methods or comparison to a legally marketed predicate device.

8. The Sample Size for the Training Set

The provided 510(k) summary does not mention a training set or its sample size. This type of information is typically associated with machine learning or AI models, which are not explicitly described as the core component of this D-Dimer assay in the summary. While the assay has a "test principle," it's a biochemical reaction and measurement, not a machine learning algorithm requiring a distinct "training set" in the conventional AI sense.

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

Since a "training set" is not mentioned or implied for this type of in-vitro diagnostic device in the provided text, this question is not applicable. The device operates on a biochemical principle, not by learning from a training dataset like a typical AI algorithm.

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