(32 days)
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Free T4, Estradiol, CK-MB and Ferritin.
Not Found
This document is a 510(k) clearance letter for the VITROS Immunodiagnostic Products Range Verifiers. Based on the provided text, the device is an in vitro diagnostic (IVD) product. The available information primarily focuses on regulatory clearance and intended use, rather than a detailed study description with specific acceptance criteria and performance data as might be found in a clinical trial report for an AI device.
Therefore, many of the requested items (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not typically included in this type of regulatory document for this kind of device.
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance
Based on the nature of the device (Range Verifiers for an immunodiagnostic system), the primary "acceptance criteria" for regulatory clearance would be substantial equivalence to a predicate device. The performance is assessed in terms of its ability to verify the calibration range for specific immunoassays.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Substantially equivalent to a legally marketed predicate device for verifying the calibration range of the VITROS Immunodiagnostic System. | The FDA found the device substantially equivalent for the stated indications for use (verifying calibration range for Free T4, Estradiol, CK-MB, and Ferritin immunoassays). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document. As this is a range verifier, the "test set" would likely refer to internal validation data, which is not detailed here.
- Data Provenance: Not specified.
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 specified for this type of IVD device regulatory clearance. Ground truth for a range verifier would be established through a comparison to a known standard or reference method, not typically by human experts interpreting results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not specified.
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 is not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is an IVD device, not an algorithm, and its function is to verify calibration ranges.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a range verifier, the "ground truth" would be the expected concentration/range values of the analytes being measured, established through highly accurate reference methods or certified reference materials. The device is designed to confirm that the VITROS Immunodiagnostic System is performing within these established ranges.
8. The sample size for the training set
- Not applicable/not specified. This is not an AI/machine learning device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.