Search Results

The Vitros® PSA is an in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma or urine. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products PSA Reagent Pack, VITROS Immunodiagnostic Products PSA Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS PSA assay).
2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
3. Common reagents used by the VITROS System in each assay.

Here's an analysis of the provided text regarding the VITROS® Immunodiagnostic Products PSA assay, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly define formal "acceptance criteria" in a table format with specific numerical targets. Instead, the demonstration of substantial equivalence is the primary acceptance criterion, and this is shown through comparison with a predicate device across various performance aspects.

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

The exact sample sizes for the various comparative tests are not explicitly stated in the provided text. The document mentions:

• "Comparisons of the VITROS PSA assay and the predicate device were performed with samples from a variety of clinical categories."
• "In clinical studies of apparently healthy individuals, patients with malignant disease and patients with a variety of non-malignant diseases..."
• "The serial monitoring study demonstrated that the VITROS PSA assay is substantial equivalent to the predicate device in patients previously treated for prostate cancer."

Data Provenance: The data is retrospective, relying on "patient specimens" and "currently commercially available reagents" (for the predicate device). The country of origin is not specified, but the submission is to the FDA, suggesting a US-centric regulatory context.

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

This information is not provided in the text. As this is an in vitro diagnostic (IVD) assay for quantitative measurement of PSA, the "ground truth" would likely be the quantitative values obtained from the predicate device (Hybritech Tandem-R PSA) as the reference, rather than expert consensus on image interpretation or clinical diagnosis. The predicate device itself (which was FDA-approved) serves as the established gold standard for comparison.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving human interpretation of diagnostic results (e.g., radiology, pathology) to establish a consensus ground truth. For a quantitative IVD assay like PSA, the ground truth is a numerical value, and the comparison is statistical (correlation, regression) rather than based on expert consensus of discrete diagnostic labels.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This submission describes an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would be used by human readers (e.g., radiologists, pathologists) to interpret complex data. Therefore, an MRMC study and effects on human reader performance are not relevant to this device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this study represents a standalone performance evaluation of the VITROS PSA assay. The device itself (the immunoassay system) produces a quantitative result, and its performance is assessed against an established predicate device. There is no human interpretation or human-in-the-loop component being evaluated for improvement.

7. The Type of Ground Truth Used

The primary "ground truth" for the test set is the quantitative measurement of PSA obtained from the predicate device, Hybritech Tandem-R PSA. This is implied by the extensive comparison using Bablock Passing regression, which calculates the relationship between the new device's readings and the predicate's readings. The predicate device itself serves as the reference standard for established diagnostic values.

8. The Sample Size for the Training Set

The document does not explicitly state any "training set sample size" or a clear distinction between training and test sets in the modern machine learning sense. For an immunoassay, the development process (which could be analogous to "training") would involve extensive R&D, optimization, and characterization using various reagent lots, controls, and calibration materials, rather than a distinct "training set" of patient data for an algorithm. The submitted data focuses on the validation or test set performance against the predicate.

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

As there's no explicitly defined "training set" in the context of an algorithm, the concept of establishing ground truth for it doesn't directly apply. The immunoassay itself is designed and optimized based on known biochemical principles and analytical performance targets. The "ground truth" for developing the assay would involve purified PSA standards, established reference methods, and internal characterization studies to ensure accurate and precise measurement.

Ask a specific question about this device