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A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serve or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.

Homogeneous Enzymic Homocysteine Reagent

The provided text is a 510(k) clearance letter from the FDA for a Homogeneous Enzymic Homocysteine Reagent. It confirms that the device is substantially equivalent to previously marketed devices. However, this document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

The letter is a regulatory approval document and focuses on the administrative aspects of device clearance, such as classification, regulation, and marketing permission, rather than the detailed technical study results that would typically include acceptance criteria and performance data.

Therefore, I cannot provide the requested table and study details based solely on the input document.

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A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.

Homogeneous Enzymic Homocysteine Reagent

The provided text is a 510(k) clearance letter from the FDA for a diagnostic reagent, not a device that relies on a test set, ground truth, or expert review in the way a typical AI/ML-powered medical device would. Therefore, most of the requested information regarding acceptance criteria, study data, ground truth establishment, expert involvement, and sample sizes is not applicable in this context.

However, I can extract the relevant information from the document to address the spirit of your request where possible, focusing on what this type of regulatory document typically provides for a diagnostic reagent.

1. A table of acceptance criteria and the reported device performance

For a diagnostic reagent like this, the "acceptance criteria" are generally established through validation studies showing that the reagent performs as intended (e.g., accuracy, precision, linearity, interference studies) and is substantially equivalent to a legally marketed predicate device. The 510(k) letter itself does not contain a table of acceptance criteria or performance metrics directly, but rather states that the device has been reviewed and found substantially equivalent.

• Acceptance Criteria (Inferred from 510(k) process for diagnostic reagents): The device (Homogeneous Enzymic Homocysteine Reagent) performs comparably to a legally marketed predicate device for quantitative measurement of total homocysteine in serum or plasma, demonstrating appropriate accuracy, precision, linearity, and freedom from significant interferences.
• Reported Device Performance: The document states that the FDA "reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976..." This implicitly means the performance data submitted by Intersect Systems, Inc. met the FDA's requirements for substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the FDA 510(k) clearance letter. For a diagnostic reagent, validation studies would typically involve testing samples from various patient populations (prospective or retrospective) to assess performance characteristics. The specific details of these studies, including sample size and provenance, are part of the 510(k) submission, but not summarized in the public clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept of "ground truth" and "experts" as in imaging or clinical decision support AI is not directly applicable to a chemical diagnostic reagent. The "ground truth" for a reagent's performance is typically established by comparing its measurements to a recognized reference method or a legally marketed predicate device, often using clinical samples where the homocysteine levels are known or confirmed by other means.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for subjective interpretations, especially in imaging or expert review panels. A chemical reagent's performance relies on quantitative measurements, not subjective adjudication of results.

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. MRMC studies and "human readers with/without AI assistance" are relevant for AI-powered assistive diagnostic devices, particularly in imaging. This device is a chemical reagent, not an AI system that assists human readers.

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

Not Applicable. This is a chemical reagent. Its performance is inherent to its biochemical reaction and the instrument it is used on, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a diagnostic reagent, the "ground truth" for validation would typically be established by:

• Reference Methods: Comparison to established, highly accurate analytical methods for measuring homocysteine.
• Predicate Device Comparison: Direct comparison of results with a legally marketed, substantially equivalent homocysteine reagent.
• Clinical Samples: Testing samples from patients with known disease states or from healthy individuals, where homocysteine levels were confirmed by other clinical means.

The specific type of ground truth used by Intersect Systems, Inc. for their submission is not detailed in this 510(k) clearance letter.

8. The sample size for the training set

Not Applicable. Chemical reagents do not have "training sets" in the context of machine learning. Their formulation and performance characteristics are determined through chemical and biochemical development, optimization, and rigorous validation studies.

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

Not Applicable. As there is no "training set" for a chemical reagent in the AI/ML sense, there is no ground truth established for it.

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