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The Access® PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prostate-specific antigen (PSA) in human serum using the ACCESS Immunoassay System. PSA measured by the Access PSA Immunoassay, is used as an aid in the management of patients with prostate cancer.

The ACCESS® PSA Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of PSA in human serum.

The provided document describes a 510(k) submission for the ACCESS® PSA Assay, which is intended for quantitative determination of Prostate-Specific Antigen (PSA) in human serum and for use as an aid in the management of patients with prostate cancer. The acceptance criteria and supporting studies are presented in comparison to a predicate device, the Tandem®-R PSA assay.

Here's a breakdown of the requested information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative manner for all parameters, but rather demonstrates performance by comparing to a predicate device and presenting observed results. For the purpose of this analysis, the "reported device performance" are the results achieved in the described studies, implying these met the implicit acceptance criteria for substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Correlation: 293 samples
• Expected Range: Population of apparently healthy males (exact number not specified)
• Monitoring Data: 127 monitoring samples from a total of 29 previously diagnosed prostate cancer patients.

Data Provenance: The document does not explicitly state the country of origin. It is a retrospective analysis from "previously diagnosed prostate cancer patients" for monitoring data and "a population of apparently healthy males" for expected range. For correlation, it involved samples "run with both the ACCESS® PSA Immunoassay and the Tandem®-R PSA assay," implying collected samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The clinical assessment mentioned for monitoring data would inherently involve expert opinion, but no specific adjudication process (e.g., 2+1) is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC comparative effectiveness study involving human readers. It focuses on the analytical performance of the assay itself compared to a predicate device and clinical assessment, not on how human interpretation of results might be improved with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes. The studies described are standalone performance evaluations of the ACCESS® PSA Immunoassay system. The results presented (correlation, expected range, recovery, precision, specificity, analytical sensitivity) characterize the sensor/algorithm performance directly without human-in-the-loop interaction in the measurement itself. The "monitoring data" section notes that results were compared to "concurrent clinical assessment or predicted the subsequent clinical assessment," which reflects the assay's utility in a clinical context, but the assay itself is standalone.

7. The Type of Ground Truth Used

• Correlation: The predicate device (Tandem®-R PSA assay) served as the reference standard for comparison.
• Expected Range: Statistical distribution within a defined population of "apparently healthy males."
• Monitoring Data: Reference was against the predicate device's results and "concurrent clinical assessment or predicted the subsequent clinical assessment," implying clinical diagnosis/progression as determined by clinicians.
• Recovery/Precision/Specificity/Analytical Sensitivity: These are intrinsic analytical performance measures, where "ground truth" is established by controlled experiments (e.g., known spikes of PSA, defined sample matrices for specificity).

8. The Sample Size for the Training Set

The document does not provide details about a specific "training set" or its size. This is a 510(k) submission for an in-vitro diagnostic device, not typically a machine learning algorithm that undergoes traditional "training" in the same sense. The development and validation phases would involve various samples used for assay optimization and calibration, but these are not explicitly referred to as a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" for a machine learning algorithm with established ground truth is not explicitly applicable here. For the development and calibration of the immunoassay, ground truth would have been established through:

• Known concentrations: For calibrators and controls used to create standard curves and validate linearity.
• Reference materials: Utilizing certified reference materials or highly characterized samples for method development and optimization.
• Comparison to reference methods: Performance during development would be benchmarked against existing, established PSA measurement techniques.

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