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The Homocysteine Microtiter Plate Assay is intended for the quantitative determination of total L-homocysteine in human serum or plasma.

The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Homocysteine Microplate HPB Assay is an EIA-like assay for the determination of tHcy (L-homocysteine) in blood. The assay employs a genetically engineered Homocysteine Binding Protein (HBP) as the capturing reagent. Plasma samples are pretreated in vials with a reducing agent, TCEP, to reduce the protein bound Hcy to free Hcy that is subsequently converted to S-adenosyl-L-homocysteine (SAH) by SAH hydrolase and quantitated by the HBP in a competition assay between free SAH from samples and tracer SAH-HRP conjugate.

The provided text describes a 510(k) premarket notification for the Diazyme Homocysteine Microtiter Plate Assay, comparing it to an existing predicate device (Axis Homocysteine EIA). However, it does not explicitly state acceptance criteria or provide a detailed study report that proves the device meets specific acceptance criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a previously cleared device (Axis Homocysteine EIA, K980907), rather than presenting a standalone performance study with defined acceptance criteria.

Therefore, many of the requested elements (like sample size for test set, number of experts, adjudication method, MRMC study, ground truth for test set and training set, and training set size) are not available in the provided text.

Based on the available information, here's what can be extracted and inferred:

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

Since explicit acceptance criteria are not provided, this table will reflect the general comparison points for substantial equivalence. The "performance" mentioned in the document refers to the overall comparability to the 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):

Not available in the provided text. The document states "The following areas were evaluated and shown to be substantially equivalent comparisons to the predicate," implying a performance comparison was done, but specific details about the study design, sample size, or data provenance are not included.

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):

Not applicable/available. This type of information is typically related to diagnostic accuracy studies where expert consensus or interpretations are used to establish a "ground truth" for a classification task. For a quantitative assay like this, the ground truth would likely be established by a reference method or known concentrations, not expert consensus in the same way. The document does not describe the method for establishing "ground truth" for any performance evaluation.

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

Not applicable/available. Adjudication methods are relevant when multiple readers/experts are interpreting results that require consensus. This is not described for the performance comparison of this quantitative assay.

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 document describes a quantitative assay for Homocysteine, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant to this submission.

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

Yes, implicitly. The "Performance" evaluation (mentioned as one of the areas shown to be substantially equivalent) would typically involve testing the device (the assay) directly against the predicate device to demonstrate similar analytical characteristics. This essentially represents the standalone performance of the assay. However, no specific details of this standalone performance study are provided (e.g., number of samples, statistical methods, specific metrics).

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

Not explicitly stated, but likely a reference method or known concentrations. For a quantitative assay measuring a biomarker like homocysteine, the "ground truth" for evaluating performance (precision, accuracy, linearity, correlation) would typically involve:

• Reference methods: Comparing results to a gold standard method.
• Known concentrations: Testing samples with precisely determined homocysteine levels.
• Spiked samples: Adding known amounts of homocysteine to samples.
• Patient samples compared to a predicate device: As this document emphasizes substantial equivalence to the Axis Homocysteine EIA, the predicate device's results would serve as a comparative "truth" or benchmark for the performance evaluation.

8. The sample size for the training set:

Not applicable/available. This document describes a chemical assay, not an AI/machine learning model that requires a training set. If an AI component were involved, this information would be crucial, but it is not relevant to this type of device.

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

Not applicable/available. As mentioned above, this device is not an AI/machine learning model needing a training set.

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