(29 days)
DPC's PSA Control Module is designed for use as an assayed quality control serum in the clinical chemistry laboratory to monitor the accuracy and precision of both the Coat-A-Count PSA IRMA and IMMULITE PSA procedures. They are intended strictly for in vitro diagnostic use
DPC's PSA Control Module is an assayed tri-level control intended for use in the quality control of DPC's Coat-A-Count PSA IRMA assav and DPC's IMMULITE PSA assay.
The provided document is a 510(k) summary for a "PSA Control Module," which is a quality control device for PSA assays. As such, it is not a diagnostic device that would typically have acceptance criteria related to diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or a study involving human readers or extensive clinical validation as requested in the prompt.
Therefore, most of the information requested in your prompt is not applicable to this specific device and document.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The document describes a "control module" used for quality control of other assays. It does not perform a diagnostic function itself, so there are no diagnostic performance metrics (sensitivity, specificity, etc.) or associated acceptance criteria in the typical sense. Its performance is related to its stability and ability to provide a known value for quality control, but these details are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Not Applicable. No test set for diagnostic performance is mentioned. The device is a control, not a diagnostic test being evaluated against patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth for diagnostic outcomes is not relevant for a quality control device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or human adjudication is mentioned.
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:
- Not Applicable. This is not an AI-assisted diagnostic device, nor does the document describe any MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Ground truth for diagnostic accuracy is not relevant for this quality control device. The "ground truth" for a control material would be its assigned value, established through a different kind of assay and certification process, which is not detailed here.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is involved.
Summary from the provided document:
The document states:
- Clinical Studies: "Not applicable"
- Conclusion: "The conclusions drawn from the nonclinical tests demonstrate that the device is safe and effective."
This indicates that the safety and effectiveness of this control module were likely established through non-clinical tests such as stability studies, manufacturing quality control, and verification that the controls perform as expected within the specified DPC assays (Coat-A-Count PSA IRMA and IMMULITE PSA). Details of these non-clinical tests are not provided in the 510(k) summary.
§ 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.