(56 days)
Intended for the calibration of multiple in vitro quantitative chemistry assays on automated chemistry analyzers, such as the Roche Cobas Mira Chemistry Analyzers. "A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens."
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The provided text is a 510(k) premarket notification letter from the FDA regarding a JAS Chemistry Calibrator. This device is a calibrator intended for use in calibrating multiple in vitro quantitative chemistry assays on automated chemistry analyzers.
Based on the information provided, this document addresses a diagnostic device that performs calibration, not an AI/ML-driven device or study evaluating human reader performance. Therefore, most of the requested information (acceptance criteria, device performance metrics, study design elements for AI/ML, human reader studies, etc.) is not applicable or extractable from this regulatory document.
However, I can extract information related to the device type and its intended use.
1. A table of acceptance criteria and the reported device performance
- This document does not contain any acceptance criteria or reported device performance data. It is a regulatory clearance letter, not a performance study report. For a calibrator, acceptance criteria would typically involve accuracy, precision, linearity, and stability, but these are not present here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document does not describe a clinical study or a test set as defined for AI/ML performance evaluation. Calibrator performance is typically evaluated by methods like linearity, recovery studies, and value assignment, not through test sets with human specimens in the context of diagnostic accuracy.
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. Ground truth in the context of calibrators refers to the accurately assigned values for the analytes within the calibrator, which are established through certified reference materials and rigorous analytical methods, not typically by expert consensus in the diagnostic sense implied by the question.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- No. This device is a chemical calibrator, not an AI/ML diagnostic algorithm that would be used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical chemical calibrator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a chemical calibrator, the "ground truth" for its assigned values would be established through traceability to internationally recognized reference materials and/or methods, often involving multiple reference laboratories and certified analytical techniques. This is a metrological concept, distinct from clinical ground truth like pathology or expert consensus. The document does not specify how the values for this particular calibrator were established.
8. The sample size for the training set
- Not applicable. There is no "training set" for a chemical calibrator in the sense of AI/ML.
9. How the ground truth for the training set was established
- Not applicable.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.