(108 days)
The RDI Ferritin Calibrator Set is intended for medical purposes for use with the RDI Ferritin Kit to establish points of reference that are used in the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement.
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The provided text is related to a 510(k) premarket notification for a medical device called the "RDI Ferritin Calibrator Set." This document is a letter from the FDA to the manufacturer, confirming substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria or a study proving device performance in the way typically expected for a diagnostic or AI-based device.
The RDI Ferritin Calibrator Set is a calibrator, meaning it's used to establish a reference for quantitative measurements in a laboratory test (the RDI Ferritin Kit). Its performance is typically assessed by ensuring it produces consistent and accurate calibration curves, which in turn allows the associated assay (the RDI Ferritin Kit) to accurately measure ferritin levels.
Therefore, most of the questions you've asked, which are relevant to clinical studies validating the performance of a diagnostic or AI device (e.g., sample size for test sets, experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device and are not present in this document.
However, I can extract the relevant information from the document:
1. A table of acceptance criteria and the reported device performance:
- Not applicable / Not provided in this document. This document is a regulatory approval letter, not a performance study report. The acceptance criteria for a calibrator would typically relate to its ability to accurately calibrate the assay it is designed for, ensuring linearity, precision, and stability. These specific criteria and their fulfillment are not detailed here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided in this document. This document does not describe a clinical performance study using patient samples. Test sets as typically understood for diagnostic devices are not relevant here.
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 / Not provided in this document. Ground truth, in the context of clinical device validation, refers to a definitive diagnosis or measurement. For a calibrator, "ground truth" would relate to the certified values of the calibrator itself, and its ability to correctly calibrate an assay, rather than a clinical expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided in this document.
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 / Not provided in this document. This is a calibrator, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided in this document. This is a physical calibrator set for an in vitro diagnostic assay, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided in this document. For a calibrator, the "ground truth" would be the assigned values of the calibrator materials themselves, which are established through a rigorous manufacturing and testing process to ensure accuracy and traceability to reference methods. This information is not in the FDA letter.
8. The sample size for the training set:
- Not applicable / Not provided in this document. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided in this document.
Summary of what is in the document:
- Device Name: RDI Ferritin Calibrator Set
- Intended Use: To establish points of reference for the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement, for use with the RDI Ferritin Kit.
- Regulatory Status: Class II device, found substantially equivalent to legally marketed predicate devices.
- Product Code: JIT
- Approval Date: March 13, 2006
§ 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.