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DPC's IMMULITE Third Generation PSA is intended for use with the IMMULITE Automated Immunoassay Analyzer. The IMMULITE Third Generation PSA is a solid-phase, chemiluminescent enzyme immunoassay designed for the quantitative measurement of prostate specific antigen (PSA) in serum. It is intended as an adjunctive test to aid in the management of prostate cancer.

DPC's IMMULITE Third Generation PSA assay is an in vitro diagnostic for use with DPC's IMMULITE Automated Immunoassay Analyzer, a random access instrument. The assay is intended for the quantitative measurement of PSA in human serum as an aid in the management of prostate cancer patients. The IMMULITE Third Generation PSA assay is a solid-phase, two-site sequential chemiluminescent immunometric assay. The solid phase consists of a polystyrene bead (coated with a monoclonal antibody specific for PSA) which is enclosed within an IMMULITE Test Unit (LUP1) which acts as a reaction vessel. The patient serum sample (or PSA Adjustors, LUPL and LUPH) and a reagent (LUPA, a protein buffer/serum matrix, with preservative) are simultaneously introduced and incubated for approximately 30 minutes at 37°C in the Test Unit. With intermittent agitation, PSA in the sample becomes bound to the surface of the bead. Unbound serum is then removed by a centrifugal wash. A second reagent (LUPB, alkaline phosphatase-conjugated polyclonal antibody) is introduced, and the Test Unit is incubated for another 30-minute cycle. Unbound enzyme conjugate is removed by a centrifygal wash, after which a chemiluminescent substrate (LSUB, a phosphate ester of adamanty) dioxetane) is added and the Test Unit is incubated for a further 10 minutes. The substrate undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light. The bound complex (and thus also the photon output as measured by the luminometer) is proportional to the concentration of PSA in the sample. The concentration of PSA in the patient sample is obtained using a stored master calibration curve within the IMMULITE analyzer.

Here's a summary of the acceptance criteria and study details for the Diagnostic Products Corporation IMMULITE Third Generation PSA, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of specific thresholds for correlation coefficients or regression parameters. Instead, the study aims to demonstrate substantial equivalence to two legally marketed predicate devices. The reported performance is based on method comparisons.

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

• Sample Size for Hybritech Comparison: 285 specimens
• Sample Size for Tosoh Comparison: 162 specimens
• Data Provenance: The document states "In an outside study," suggesting the data was collected externally from DPC, but it does not specify the country of origin or if it was retrospective or prospective.

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 document. The ground truth for this type of assay is derived directly from the results of the predicate devices rather than expert interpretation of images or other subjective data.

4. Adjudication Method for the Test Set

This information is not applicable as the comparison is between quantitative assay results, not subjective interpretations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay for measuring a biomarker (PSA) and does not involve human readers interpreting images or data where AI assistance would be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a standalone algorithm, in the sense that it is an automated immunoassay that provides a quantitative result without direct human intervention in the result generation itself. Its performance is compared directly to other established standalone assays.

7. The Type of Ground Truth Used

The ground truth used for performance comparison was the results obtained from the legally marketed predicate devices: Hybritech Tandem-R® PSA and Tosoh AIA-PACK® PA. The performance of the new device (IMMULITE Third Generation PSA) was compared against these established methods.

8. The Sample Size for the Training Set

The document does not report the sample size for a "training set." As an IVD assay, the 'training' would likely involve internal method development and optimization, rather than a separate, explicitly defined clinical "training set" in the context of machine learning or AI.

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

This information is not provided in the document. For an IVD assay, the ground truth for internal development and optimization would typically be established based on highly characterized reference materials and established analytical methods aiming for accuracy, precision, and linearity.

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