(19 days)
The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems.
The Elecsys® PreciControl MultiAnalyte is a lyophilized product consisting of synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided text describes the Elecsys® PreciControl MultiAnalyte, a quality control material, and its substantial equivalence to a predicate device. However, the document does NOT contain information about specific acceptance criteria for performance metrics (such as sensitivity, specificity, or accuracy) or a detailed study proving the device meets particular criteria. Instead, it focuses on comparing the new device to a predicate device for regulatory purposes.
Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics cannot be directly extracted from the provided text.
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or other performance metrics). It only states that the device "was evaluated for value assignment and stability" under "Performance Characteristics," but does not report the results of these evaluations or against what specific criteria they were judged.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention any test sets, sample sizes, or data provenance for performance evaluation.
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. The concept of "ground truth" established by experts in the context of diagnostic performance studies is not applicable to this document, which describes a quality control material rather than a diagnostic device requiring such evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. This information is not relevant to the type of device described (quality control material) and is not present in the 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 is irrelevant to the device described, which is a quality control material, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is irrelevant as the device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. As explained in point 3, the concept of "ground truth" in this context is not applicable. The device is a control to ensure the accuracy of other immunoassays.
8. The sample size for the training set
- Cannot be provided. There is no mention of a "training set" as this is not an algorithm being developed.
9. How the ground truth for the training set was established
- Cannot be provided. There is no training set mentioned.
§ 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.