(55 days)
A1c-Chex is a bi-level whole blood based, assayed control for monitoring performance of analysis procedures for HbA1c.
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The provided document is a 510(k) Summary for the A1c-Chex device, a quality control material for monitoring the performance of HbA1c analysis procedures. The document focuses on demonstrating substantial equivalence to a predicate device and does not include a detailed study proving specific acceptance criteria for a new AI-powered medical device.
Therefore, many of the requested details about acceptance criteria, efficacy studies with AI, and detailed ground truth methodologies are not present in this type of regulatory submission. The information below is extracted from the provided text, and where information is not available, it is noted as "Not applicable" or "Not provided".
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific numerical acceptance criteria (e.g., a target precision value or stability range). Instead, it states general conclusions about performance in relation to the predicate device.
| Acceptance Criteria (General) | Reported Device Performance (as stated in document) |
|---|---|
| Reproducibility | A1c-Chex is consistently reproducible. |
| Substantial Equivalence | A1c-Chex is substantially equivalent to the effective predicate device. |
| Performance over product dating | Maintains performance over the entire product dating. |
| Safety and Effectiveness | A1c-Chex is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert. |
| Closed Vial Stability | Studies were conducted to establish this. Conclusion: maintained performance over entire product dating. |
| Open Vial Stability | 30 days (compared to 14 days for predicate). Studies were conducted to establish this. Conclusion: maintained performance over entire product dating. |
| Precision | Studies were conducted to establish this. Conclusion: consistently reproducible. |
| Proposed Assay Sheet accuracy | Studies were conducted to establish this. Conclusion: substantially equivalent to predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Studies were conducted" for stability, precision, and the proposed assay sheet, but does not provide details on the number of samples or tests performed.
- Data Provenance: Not provided. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The testing relates to the performance of a quality control material, not a diagnostic device requiring expert interpretation of results to establish ground truth.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for diagnostic interpretation where there's a need to resolve discrepancies between readers. This device is a quality control material.
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. This is a quality control material for laboratory tests, not a diagnostic device involving human readers or AI assistance. An MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a quality control material, not an algorithm, and does not involve AI or human-in-the-loop performance in the context of its regulatory submission.
7. The type of ground truth used
- For a quality control material, the "ground truth" is typically established by the manufacturer through a rigorous process of characterizing the material's properties (e.g., target analyte concentration, stability over time). This is done through internal analytical testing rather than external expert consensus, pathology, or outcomes data in the way it's understood for diagnostic devices. The document implies that the studies conducted (stability, precision, assay sheet) directly characterize the material itself.
8. The sample size for the training set
- Not applicable. This device is a quality control material, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a quality control material, not an AI algorithm requiring a training set.
§ 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.