(90 days)
The Primidone Calibrators are in-vitro diagnostic medical devices intended to be used for calibration of DRI Primidone EIA Assay for quantitative determination of Primidone in human serum or plasma.
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The provided document is a 510(k) premarket notification letter from the FDA regarding "Primidone Calibrators." This type of document is a regulatory approval for a medical device and does not contain the detailed study information generally associated with artificial intelligence/machine learning (AI/ML) device approvals, which would discuss acceptance criteria based on performance metrics like sensitivity, specificity, AUC, etc.
The device discussed here, "Primidone Calibrators," is an in-vitro diagnostic (IVD) medical device used for the calibration of a specific immunoassay (DRI Primidone EIA Assay) to quantitatively determine Primidone levels in human serum or plasma. This is a chemical calibrator, not an AI/ML powered diagnostic device that analyzes images or complex data and therefore the questions in the prompt are largely not applicable.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. For calibrators, acceptance criteria would typically relate to their accuracy, precision, stability, and linearity in calibrating an assay. The document confirms the device is substantially equivalent to legally marketed predicate devices, implying it meets similar performance standards, but specific criteria and reported performance values are not detailed.
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 present. Calibrator performance is typically evaluated through analytical studies using controlled samples rather than clinical test sets with data provenance.
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 information is not present. The concept of "ground truth established by experts" is not relevant for a chemical calibrator. The "truth" for a calibrator is its chemical concentration and its ability to establish a reliable standard curve for an assay.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present. Adjudication methods are typically associated with human reviewer variability in AI/ML performance evaluation, which is not applicable here.
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:
This information is not present. This type of study is entirely irrelevant for a chemical calibrator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present. This question relates to AI/ML software performance, which is not applicable to a chemical calibrator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a chemical calibrator, the "ground truth" would be the certified or precisely measured concentrations of Primidone in the calibrator solutions. This information is not explicitly detailed in the provided document, but it's an inherent requirement for such a product.
8. The sample size for the training set:
This information is not present. Chemical calibrators do not use training sets in the AI/ML sense. Their manufacturing involves highly controlled processes and quality checks to ensure accuracy and consistency.
9. How the ground truth for the training set was established:
This information is not present, for the same reason as point 8.
In summary, the provided document is a regulatory approval letter for a chemical calibrator and does not contain the detailed performance study information typically found for AI/ML powered diagnostic devices. The questions posed in the prompt are mostly not applicable to this type of device.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.