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The Diazyme Apolipoprotein B Assay is intended for the quantitative determination of apolipoprotein B (apo B) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use.

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The Diazyme Apolipoprotein B Assay is a device intended for the quantitative determination of apolipoprotein B (apo B) in serum, to be used as an aid for assessing the risk of coronary artery disease.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative sense with specific thresholds. However, it presents "Performance" data for the Diazyme Apolipoprotein B Assay and compares it to a predicate device (K-Assay Apo B Assay) to demonstrate substantial equivalence. The implication is that the performance of the Diazyme assay should be comparable or better than the predicate for regulatory acceptance.

Implicit Acceptance Criteria (inferred from predicate comparison): The Diazyme Apolipoprotein B Assay should demonstrate comparable or improved performance relative to the legally marketed K-Assay Apo B Assay, particularly in terms of reportable range, precision (within-run and total), and accuracy (correlation coefficient and slope/intercept).

The study demonstrates that the Diazyme Apolipoprotein B Assay's performance is comparable to, and in several key areas (precision within-run, correlation coefficient, and slope/intercept for accuracy), better than the predicate device. This supports the claim of substantial equivalence.

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The performance data is presented as summary statistics (ranges for precision, correlation coefficient, slope/intercept).

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

This information is not provided in the document. For in vitro diagnostic devices like the Diazyme Apolipoprotein B Assay, "ground truth" typically refers to reference methods and established standards. The document mentions that the calibrator value is "traceable to the WHO/IFCC Reference Standard" and "WHO International Reference Material for Apo B, SP3-07," which are the established reference points for accuracy. There's no mention of human experts establishing ground truth for individual samples.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1, none) are typically relevant for studies involving human interpretation of images or clinical assessments where discrepancies between readers might occur. For an automated in vitro diagnostic assay, this concept does not directly apply. The "ground truth" is based on reference methods and established standards for the analyte measurement, not expert consensus on individual case interpretation.

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

An MRMC study is not applicable nor indicated for this type of in vitro diagnostic device. MRMC studies evaluate the performance of human readers, sometimes with and without AI assistance, especially in radiology or pathology. This device is an automated biochemical assay.

6. Standalone Performance Study

Yes, a standalone performance assessment was done. The "Performance" section explicitly lists metrics for the Diazyme Apolipoprotein B Assay such as:

• Reportable Range: 25.0 – 160 mg/dL
• Precision (Within Run): 1.2% -1.4%
• Precision (Total): 2.1%–4.8%
• Accuracy (Correlation Coefficient): 0.9864
• Accuracy (Slope/Intercept): $y = 1.0143x - 4.3806$ mg/dL

These figures represent the performance of the algorithm/assay itself, without human intervention in the measurement process. The comparison to the predicate device further contextualizes this standalone performance for regulatory purposes.

7. Type of Ground Truth Used

The ground truth for the device's performance is based on:

• Reference Standards: The calibrator values are traceable to "WHO/IFCC Reference Standard" and "WHO International Reference Material for Apo B, SP3-07." These are internationally recognized reference materials that establish the true concentration of Apolipoprotein B.
• Comparative Measurements: Accuracy is shown through correlation and regression against a legally marketed predicate device (K-Assay Apo B Assay), implying that the predicate's measurements serve as a comparative standard.

8. Sample Size for the Training Set

This information is not provided in the document. For an immunoturbidimetric assay, "training set" doesn't have the same meaning as in machine learning algorithms. The development process would involve calibration and optimization using characterized materials, but not a "training set" in the common AI sense.

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

As noted above, the concept of a "training set" with established ground truth is generally not applicable in the same way for an immunoturbidimetric assay as it would be for AI/ML devices. The "ground truth" for the development and calibration of such an assay would be established using certified reference materials and calibrators with known, traceable concentrations of Apolipoprotein B, as mentioned for the calibrator's traceability to WHO/IFCC standards.

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