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The Roche Diagnostics OMNI S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urca/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.

The Roche Diagnostics OMNI S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, bilirubin. hemoglobin, oxygen saturation, oxyhemoglobin, total deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.

The provided text describes a 510(k) submission for a bilirubin assay rather than a medical device or AI algorithm with performance metrics like sensitivity, specificity, or AUC. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, not on demonstrating performance against clinical acceptance criteria in the way an AI diagnostic would.

Therefore, many of the requested categories for AI device studies (e.g., sample size of test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission. The document primarily discusses method comparison studies with existing commercial assays.

Here's an attempt to answer the questions based only on the provided text, highlighting the limitations:

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

The document does not explicitly state quantitative "acceptance criteria" for the bilirubin assay in terms of diagnostic performance (e.g., sensitivity, specificity, or accuracy targets). Instead, it discusses "acceptable performance" through method comparison studies with predicate devices.

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

The document states, "The bilirubin parameter for use on the OMNI S Analyzer was compared to several legally marketed analyzers in the method comparison studies." However, it does not specify the sample size for these method comparison studies or the data provenance (country of origin, retrospective/prospective).

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. For laboratory assays like this, "ground truth" is typically established by reference methods or validated predicate devices, not by expert interpretation in the same way as imaging diagnostics. The text does not mention any human experts establishing ground truth for the test set.

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

Not applicable. Adjudication methods are typically used in imaging or clinical studies where subjective human interpretation needs to be reconciled. For a bilirubin assay, results are quantitative measurements, and reconciliation would involve comparing numerical values, not subjective interpretations. The text does not mention any adjudication method.

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 is a laboratory assay for measuring a biomarker, not an AI-assisted diagnostic device that would involve human readers or image interpretation.

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

This refers to a standalone device, which is what the OMNI S Analyzer with the bilirubin assay is. It operates without human interpretation of results in the diagnostic pipeline beyond reading the numerical output. The entire development process would inherently evaluate its standalone performance by comparing its results to predicate devices.

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

The "ground truth" for this bilirubin assay is established by comparison to results obtained from legally marketed predicate bilirubin assays on other analyzers (Roche Hitachi Analyzers, Radiometer ABL735, Beckman LX®20 System, Kodak Vitros System). These predicate devices are considered the "truth" for establishing equivalence.

8. The sample size for the training set

Not applicable. This is a chemical assay, not an AI algorithm. There is no concept of a "training set" in the context of developing this type of device.

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

Not applicable, as there is no training set for this type of device.

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