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In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human ferritin in serum and plasma.

Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemochromatosis (iron overload) and iron deficiency anemia.

A particle enhanced immunoturbidimetric assay in which human ferritin agglutinates with latex particles coated with anti-ferritin antibodies. The precipitate is determined turbidimetrically at 552 nm.

Here's a summary of the acceptance criteria and study information for the Ferritin Generation 2 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the performance of the Ferritin Generation 2 is demonstrated by direct comparison to a predicate device (COBAS Integra Ferritin assay, K963292). The assumption is that matching or improving upon the predicate's performance indicates substantial equivalence and meets acceptance.

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

The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for any of the performance studies. It only presents the results of these studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not available in the provided text. The studies relate to the performance of an in vitro diagnostic reagent system (a lab test), not an imaging-based or clinical diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not available in the provided text. Adjudication methods are typically relevant for studies involving human interpretation of results, which is not the primary focus of this device's performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size

An MRMC comparative effectiveness study was not done. This type of study is not applicable to an in-vitro diagnostic reagent system like Ferritin Generation 2, which produces quantitative numerical results rather than interpretations requiring human readers.

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

Yes, the studies presented are standalone performance evaluations of the diagnostic reagent system itself. The precision, method comparison, and interference studies assess the device's analytical performance independent of human interpretation beyond standard laboratory procedures (e.g., pipetting, running the instrument).

7. The Type of Ground Truth Used

For the Method Comparison study, the "ground truth" for the Ferritin Generation 2 device was a predicate device, specifically the COBAS Integra Ferritin assay. The comparison assessed how closely the new device's measurements correlated with the established predicate.

For other analytical performance characteristics (Precision, Limitations, Prozone Effect, Analytical Sensitivity), the "ground truth" implicitly refers to the true analytical values of the samples being tested, typically derived from reference materials or highly accurate reference methods, although these are not explicitly detailed. The device is designed to quantitatively determine human ferritin, and the ground truth would be the actual ferritin concentration in the samples.

8. The Sample Size for the Training Set

This information is not available in the provided text. This device is a reagent system, not an AI/ML-based algorithm that typically has a "training set" in the conventional sense. Its development would involve analytical testing and validation rather than a data training process.

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

This information is not applicable as the device is not an AI/ML system with a "training set." The performance characteristics are established through various analytical validation studies using reference materials and patient samples.

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