(32 days)
FOR IN VITRO DIAGNOSTIC USE. This kit intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.
Immunoassay kit for quantitative determination of 25-hydroxyvitamin D
The provided text describes a Special 510(k) submission for a device modification to the DiaSorin 25-Hydroxyvitamin D 125I RIA Kit. The submission focuses on demonstrating substantial equivalence to a predicate device (K953567) while highlighting improved analytical sensitivity and precision of the modified device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. Instead, it refers to a comparative standard:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equal or surpass the performance characteristics of the predicate device (K953567) | • Verification and validation testing demonstrated that the performance characteristics of the modified device equaled or surpassed those of the predicate device. |
| • The modified device demonstrates improved analytical sensitivity and precision compared to the predicate device. |
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: The document states "the use of patient serum samples," but does not specify the exact number of samples used in clinical testing.
- Data Provenance: The country of origin and whether the data was retrospective or prospective are not mentioned in the provided text.
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 provided. The document describes an in vitro diagnostic device, and ground truth for such devices is typically established through reference methods or established assays, not necessarily by human expert consensus in the way it would be for an imaging AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to in vitro diagnostic device performance studies as described here. Adjudication methods are more commonly associated with human interpretation of results, particularly in imaging studies.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted human interpretation, typically in contexts like medical imaging. The DiaSorin device is an in vitro diagnostic kit for quantitative determination of a biomarker, not an AI system designed to assist human readers in interpreting complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing described appears to be a standalone performance evaluation of the modified in vitro diagnostic kit. The "Verification and validation testing" including "the use of patient serum samples" directly evaluates the performance of the device itself (the immunoassay kit) in determining 25-hydroxyvitamin D levels, independent of human interpretive intervention or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the specific "ground truth" method used. However, for an immunoassay kit, ground truth is typically established by:
- Reference methods: A highly accurate and precise method considered the "gold standard" for measuring the analyte (e.g., LC-MS/MS for vitamin D metabolites).
- Established predicate device/comparators: Comparing results to a well-characterized and legally marketed assay that serves as the basis for performance evaluation.
While the document mentions comparison to the predicate device, it doesn't detail how the predicate device's accuracy itself was derived.
8. The sample size for the training set
This information is not provided. The concepts of "training set" are primarily relevant to machine learning or AI models. This device is an immunoassay kit, which is a chemical and biological assay, not trained using data in the same way an AI algorithm would be.
9. How the ground truth for the training set was established
Not applicable as this is an immunoassay kit, not an AI model requiring a training set developed with ground truth.
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.