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The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

The Access Ferritin reagents, Access Ferritin Calibrators and the Access Wash Buffer used in conjunction with the Access Immunoassay Analyzers (Access, Access 2, Synchron LX® 725, and UniCel DxI™ 800) comprise the Access Immunoassay Systems for the quantitative determination of ferritin levels in human serum and plasma (heparin).

The 510(k) summary provided describes the "Ferritin on the Access® Immunoassay Systems" device and a modification to it. The modification involves the addition of an auto-dilution feature and a change to the assay protocol file for improved particle mixing and reagent aspiration. The document asserts that these changes do not affect assay performance characteristics.

However, the provided text does not include a detailed study that proves the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert involvement as requested. What is provided is a statement of substantial equivalence to a predicate device, based on the absence of changed performance characteristics due to the modification.

Therefore, many of the requested elements for describing the acceptance criteria and study are not available in the provided document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria (e.g., precision, accuracy, linearity targets) and their corresponding achieved performance values are explicitly stated in the provided text. The document states:

• "The change does not affect assay performance characteristics."
• "The changes do not affect assay reaction kinetics."

This implies that the modified device's performance is expected to be substantially equivalent to the predicate device, but no quantitative performance data or specific acceptance criteria are presented.

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

• Sample size for test set: Not mentioned.
• Data provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

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

Not applicable, as no study establishing ground truth for a test set is described. The submission focuses on modifications to an existing device, asserting that performance characteristics are unchanged.

4. Adjudication method for the test set

Not applicable, as no study establishing ground truth for a test set is described.

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 device is an automated immunoassay system, not an AI-assisted diagnostic tool for human readers.

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

This is an automated immunoassay system, so its inherent mode of operation is "standalone" in terms of direct measurement. However, no specific "standalone performance study" with detailed metrics is described beyond the assertion that performance characteristics are unchanged.

7. The type of ground truth used

Not explicitly stated for any evaluation related to the auto-dilution feature or assay protocol file modification. The primary justification for substantial equivalence is that the modifications do not affect the established performance of the predicate device.

8. The sample size for the training set

Not mentioned. This type of device (immunoassay) generally relies on calibration materials and quality control samples rather than a "training set" in the machine learning sense.

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

Not applicable, as no "training set" in the machine learning sense is described. Calibrators are mentioned (Human liver ferritin at various levels), which would have their values established by a reference method, but the details are not in the document.

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