(31 days)
For in vitro diagnostic use only.
The RDI Extended Range CRP Calibrator Set is intended for medical purposes for use with the RDI Extended Range hsCRP Kit, to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.
Not Found
This looks like a 510(k) clearance letter for a medical device called "RDI Extended Range CRP Calibrator Set."
Based on the provided text, the document is a regulatory approval and does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/software devices.
Here's why and what information is available:
- Device Type: This device is a "Calibrator" (specifically, an "Extended Range CRP Calibrator Set"). Calibrators are used to establish reference points for assays (like a C-reactive protein assay). They are not typically "devices" in the sense of AI algorithms that perform an analysis or make a diagnosis.
- Regulatory Pathway: This is a 510(k) premarket notification, indicating a claim of substantial equivalence to a legally marketed predicate device. This pathway often focuses on demonstrating that the new device is as safe and effective as an existing one, rather than novel performance studies with acceptance criteria as you've described for AI.
- Content of the Document: The letter is an official notification of clearance from the FDA. It confirms that the device can be marketed. It discusses general controls, regulations, and labeling, but it does not present a detailed study report or performance data.
Therefore, I cannot fill out the requested table or answer most of your questions as the information is not present in the provided text.
Here is what can be extracted to answer some parts, and explanations for why other parts cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not contain acceptance criteria or performance data for the calibrator in the way you've outlined. The FDA's substantial equivalence determination implies that the device performs comparably to a predicate, but the specific performance metrics and acceptance thresholds are not detailed here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No study data (test set size, provenance) is included in this regulatory clearance letter.
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)
- Cannot be provided. This is not relevant for a calibrator's regulatory clearance and no such information is in the document. Ground truth for a calibrator would typically relate to its manufactured concentration values and traceability to international standards, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. Not applicable or available 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
- Cannot be provided. This relates to AI/software performance with human readers, which is not what this device is.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a calibrator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a calibrator, the "ground truth" is its manufactured, certified value. The document mentions: "The accuracy of the CRP measurement is insured by using calibrators that are traceable to the international reference preparation (CRM470)." This indicates that the ground truth for the calibrator's values comes from its traceability to an internationally recognized standard.
8. The sample size for the training set
- Cannot be provided. Not applicable for this type of device and no such information is in the document.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable for this type of device and no such information is in the document.
In summary, the provided text is an FDA 510(k) clearance letter for a calibrator, which is a different type of medical device than an AI-driven diagnostic tool. Therefore, most of the questions, which are tailored to AI/software performance studies, cannot be answered from this document.
§ 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.