(57 days)
DPC's PSA Controls are designed for use as an assaved quality control serum in the clinical chemistry laboratory to monito, the accuracy and precision of the Coat-A-Count PSA IRMA procedure. They are intended strictiv for in vitro diagnostic use.
DPC's PSA Controls are assaved tri-level controls intended for use in the quality control of DPC's Coat-A-Count PSA IRMA.
Unfortunately, based solely on the provided text, I cannot provide the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria.
The 510(k) summary for the "PSA Controls" device explicitly 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 device, in this case, a control material for an immunoassay, was not subjected to a clinical study with patients to evaluate diagnostic accuracy in the way described in your request (e.g., comparing AI to human readers, using ground truth from pathology, etc.).
The "acceptance criteria" for this specific device would relate to its performance as a quality control material, likely involving metrics such as:
- Target Concentration Values: The expected PSA levels for each control (PSAC1, PSAC2, PSAC3).
- Acceptable Range/Tolerance: The range within which the measured PSA values for the controls must fall when run on the Coat-A-Count® PSA IRMA, indicating the assay is performing correctly.
- Stability: How long the controls maintain their target values under specified storage conditions.
- Lot-to-Lot Consistency: Variability between different manufacturing lots of the controls.
The "study that proves the device meets the acceptance criteria" would therefore be non-clinical, manufacturing-based studies and quality control testing, rather than a clinical trial with patient data or expert readers.
Therefore, I cannot fill out the requested table or answer the specific questions about sample sizes, expert ground truth, MRMC studies, standalone performance, or training sets, as these elements are not relevant to a device for which clinical studies are deemed "not applicable."
The provided 510(k) is for a control device, which is used to monitor the performance of an assay (DPC's Coat-A-Count® PSA IRMA), not a diagnostic algorithm that generates patient-specific results. The regulatory pathway for such control devices often relies on demonstrating manufacturing consistency, stability, and appropriate target ranges, rather than clinical efficacy studies in the conventional sense.
§ 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.