(169 days)
For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Anti-TSHR CalCheck is a lyophilized product consisting of human anti-TSHR antibodies in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided text describes the 510(k) premarket notification for the Elecsys Anti-TSHR CalCheck, a quality control material. However, it does not contain detailed information regarding acceptance criteria, specific study results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about comparative effectiveness studies (MRMC) or standalone algorithm performance.
The document primarily focuses on establishing substantial equivalence to a predicate device (Elecsys C-Peptide CalCheck K040157) based on intended use, levels, format, handling, and stability. While it mentions that "The Elecsys Anti-TSHR CalCheck was evaluated for value assignment and Performance Characteristics stability," it does not provide the results of these evaluations or specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's what can be inferred or stated based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (The document mentions evaluation for "value assignment and Performance Characteristics stability" but does not report the results or specific criteria met.) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified. The study was conducted by Roche Diagnostics, but the origin of the samples (e.g., country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is a quality control material for an immunoassay analyzer. The "ground truth" for a quality control material typically refers to its assigned value and stability characteristics, which are determined through laboratory testing and characterization. It does not typically involve human expert interpretation in the same way an imaging diagnostic device might. Therefore, the concept of "experts establishing ground truth" in this context is not directly applicable, and no information on such experts is provided.
4. Adjudication method for the test set
- Not applicable as this is a quality control material and not a diagnostic algorithm requiring human adjudication of test results.
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, an MRMC study was not done. This is a quality control material, not an AI-powered diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used
- The "ground truth" for a quality control material (like Elecsys Anti-TSHR CalCheck) would be its assigned values for the analyte, determined through rigorous laboratory characterization and potentially traceability to reference materials. The document states it was "evaluated for value assignment," implying this type of ground truth was established by the manufacturer.
8. The sample size for the training set
- Not applicable. This is a quality control material, not an AI or machine learning algorithm that requires a training set. The "samples" described would be batches of the CalCheck material itself, which are characterized for their properties.
9. How the ground truth for the training set was established
- Not applicable, as no training set for an algorithm is involved.
§ 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.