(73 days)
For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems.
The Bayer ADVIA® IMS cPSA Controls are bovine serum based with non-serum constituents added. The analytes currently in the control material are: cPSA
This document is a 510(k) summary for the ADVIA® IMS cPSA Control, a quality control material. It describes the device, its intended use, and its substantial equivalence to a predicate device. As a quality control material used to monitor the performance of other assays, the acceptance criteria and study design are different from those for diagnostic devices that detect a disease. This document does not describe a clinical study in the typical sense with patient data, expert readers, or AI performance metrics.
Here's an analysis of the provided text based on the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of performance specifications for the ADVIA® IMS cPSA Control itself. Instead, it describes its intended use as a quality control material "to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems."
The "reported device performance" of the ADVIA® IMS cPSA Control is implied by its function as a control. The key performance characteristics for such a control material would typically be its assigned values (which establish accuracy) and its stability (which ensures its continued utility for precision monitoring over time). However, these specific values or stability data are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The device is a quality control material, not a diagnostic device that processes patient samples or generates diagnostic data. There is no "test set" in the sense of 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 and not provided. As explained above, there is no "test set" of patient data requiring expert-established ground truth. The "ground truth" for a quality control material would be its manufacturing specifications and assigned analyte values, determined through laboratory methods, not expert consensus on patient cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided for the same reasons as above.
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 and not provided. This device is a quality control material, not an AI-powered diagnostic tool, and therefore no MRMC study or AI-related effectiveness study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" refers to its assigned analyte values (in this case, cPSA concentration) and its manufacturing specifications. These are established through rigorous laboratory testing during the development and manufacturing process, comparing it against reference materials and methods. The document does not detail how these specific values were established but implies they are part of the product specifications.
8. The sample size for the training set
This information is not applicable and not provided. This device is a quality control material, not a machine learning algorithm, and therefore has no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as above.
§ 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.