(28 days)
Elecsys® PreciControl Multimarker is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers.
Elecsys® PreciControl Multimarker is a lyophilized product consisting of analytes in an equine serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided text describes a 510(k) summary for the Elecsys® PreciControl Multimarker, a quality control device. The information presented focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic performance against specific acceptance criteria for a new AI/CAD device.
Therefore, many of the requested fields are not applicable in this context, as they relate to evaluating the performance of a diagnostic or AI-powered medical device against a defined ground truth, which is not the purpose of this 510(k) submission for a quality control material.
Here's an attempt to answer the questions based only on the provided text, indicating "Not Applicable" where the information is absent or irrelevant to this type of device submission:
1. A table of acceptance criteria and the reported device performance
The submission states that the device was "evaluated for value assignment, stability, and duration of reconstitution." The "Conclusion" section states, "The data demonstrate that the performance of the Elecsys® PreciControl Multimarker is substantially equivalent to that of the predicate device, Elecsys® PreciControl MultiAnalyte (K033937)."
However, specific acceptance criteria (e.g., ±X% deviation from target value, specific stability limits) and the detailed reported performance data against those criteria are not provided in this summary. The summary only states that the data demonstrate equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. For a quality control material, the test set would typically be internal testing batches to establish stability and value ranges, not patient data.
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 applicable or not provided. For a quality control material, "ground truth" would likely refer to certified reference materials or established assay methods used in manufacturing and testing, not expert interpretation of diagnostic images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials, which is not the nature of this device's evaluation.
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
This information is not applicable. This is a quality control material, not a diagnostic device intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "value assignment," "stability," and "duration of reconstitution" as evaluation points. For a quality control product, the ground truth for "value assignment" would likely be derived from a validated reference method or certified reference materials. The "ground truth" for stability would be the measurement of analyte concentrations over time under specified conditions. However, the specific methodology and type of "ground truth" (e.g., specific reference standards) are not detailed in this summary.
8. The sample size for the training set
This information is not applicable. This is a quality control material; there is no "training set" in the context of machine learning or AI. The manufacturing process of preparing control material is distinct from training an algorithm.
9. How the ground truth for the training set was established
This information is not applicable as there is no 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.