(13 days)
For in vitro diagnostic use only. VITROS TDM Performance Verifiers are designed for use in assessing bias (mean) and impersion (standard deviation) for each reagent lot. Published values are derived from interlaboratory performance data. This fluid should be assayed in the same manner as a patient sample. The reported values can then be compared with those given on the assay sheet.
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This document is an FDA 510(k) clearance letter for the VITROS Chemistry Products TDM Performance Verifiers. It primarily focuses on regulatory approval rather than providing a detailed technical study report.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from this document.
The document does include a "Statement of Intended Use" which mentions how the device is designed to be used and how its performance is assessed in a general sense.
Here's what can be inferred or directly stated from the provided pages, as well as what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not contain a table of acceptance criteria.
- Inference from "Indications for Use":
- Acceptance Criteria (Implied Function): The device is intended for "assessing bias (mean) and imprecision (standard deviation) for each reagent lot." This implies that the 'acceptance criteria' for the performance verifiers themselves would be related to their stability, consistency, and ability to accurately reflect known TDM values for quality control.
- Reported Device Performance: "Published values are derived from interlaboratory performance data. This fluid should be assayed in the same manner as a patient sample. The reported values can then be compared with those given on the assay sheet." This indicates that the performance of the test system (VITROS Chemistry Products with TDM Performance Verifiers) is evaluated by comparing results from the verifiers against established "assay sheet" values, which are themselves derived from interlaboratory studies. However, the specific performance metrics (e.g., specific bias and CV% thresholds) are not given here.
2. Sample sized used for the test set and the data provenance
- Cannot be provided. The document does not specify the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). The mention of "interlaboratory performance data" suggests multiple labs contributed, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. The document does not mention the number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for the test set
- Cannot be provided. The document does not describe any adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- Cannot be provided. This type of study is not mentioned. The device is a "Performance Verifier" (quality control material), not a diagnostic algorithm typically evaluated with MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Cannot be provided. This device is a consumable diagnostic product (a "verifier" or control material), not an algorithm or AI. Standalone performance for an algorithm is not relevant here.
7. The type of ground truth used
- Inference: The "Indications for Use" states: "Published values are derived from interlaboratory performance data." This implies the ground truth for the performance verifiers' expected values (the "assay sheet" values) are established through interlaboratory consensus/comparison using various reference methods and potentially reference materials.
8. The sample size for the training set
- Not applicable/Cannot be provided. This is a quality control material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Cannot be provided. As above, this is not an AI/ML algorithm. The "ground truth" for the verifiers themselves (their expected values) would be established through robust analytical methods and interlaboratory comparisons, but the specifics are not in this document.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.