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510(k) Data Aggregation
(20 days)
In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma on Roche automated clinical chemistry analyzers. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The Roche/Hitachi Bicarbonate liquid is a ready-to-use liquid enzymatic assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A decrease in absorbance at 415 nm is proportional to the concentration of bicarbonate in the sample.
The provided text is a 510(k) summary for the Roche/Hitachi Bicarbonate liquid diagnostic device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the way medical imaging or AI-driven devices typically do.
Therefore, many of the requested categories directly related to device performance studies, such as sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance, are not explicitly provided in this type of regulatory document for a chemical assay.
However, I can extract the relevant information that is present and indicate where information is not available based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance | Comments |
|---|---|---|---|
| Intended Use | Quantitative determination of bicarbonate (HCO3-) in human serum and plasma. | In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma on Roche clinical chemistry analyzers. | Substantially equivalent to predicate. |
| Method | Enzymatic, colorimetric test. | Same. | Substantially equivalent to predicate. |
| Sample Type | Human Serum and Plasma. | Same. | Substantially equivalent to predicate. |
| Measuring Range | 0.46 - 50 mmol/L | 1.5 - 50 mmol/L | The proposed device has a slightly narrower lower limit for its measuring range (1.5 mmol/L vs. 0.46 mmol/L for the predicate). This difference was deemed acceptable for substantial equivalence. |
| Expected Values | 22 - 29 mmol/L | Same. | Substantially equivalent to predicate. |
2. Sample size used for the test set and the data provenance
The document does not explicitly mention sample sizes for a specific "test set" or data provenance (country of origin, retrospective/prospective) for performance evaluation. This type of detail is generally found in more comprehensive study reports, which are summarized rather than fully presented in a 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device based on comparable intended use, methodology, and performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of enzymatic assay. "Ground truth" in this context would refer to the accuracy of the chemical measurement, usually verified against a reference method or known concentration standards, not by expert interpretation as in medical imaging. The document does not provide details on how the accuracy was verified.
4. Adjudication method for the test set
Not applicable for this type of enzymatic 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 device is an in vitro diagnostic reagent for a chemical assay, not an AI-driven medical imaging or diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the assay itself when run on "Roche automated clinical chemistry analyzers." The performance metrics listed (measuring range, expected values, method) relate to the standalone performance of the assay system. However, specific details of a formal "standalone study" with detailed results are not provided beyond the summary table comparing it to the predicate. The FDA's substantial equivalence determination implies that this standalone performance was considered acceptable and comparable to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an enzymatic assay device, "ground truth" typically refers to the true concentration of bicarbonate in samples, established through reference methods or gravimetrically prepared standards. The document does not specify the exact methods used to establish this "ground truth" for the performance evaluation.
8. The sample size for the training set
Not applicable. This device is a chemical reagent and does not involve AI/machine learning models that require a "training set."
9. How the ground truth for the training set was established
Not applicable. This device is a chemical reagent and does not involve AI/machine learning models that require a "training set."
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