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The Bayer ADVIA® IMS cPSA assay is an in vitro diagnostic device intended to quantitatively measure complexed prostate specific antigen (cPSA) in human serum. This assay is indicated for the measurement of serum complexed PSA as an aid in management (monitoring) of prostate cancer patients. Complexed PSA values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.

Prostate Specific Antigen (PSA) is a secretory product of the epithelial cells of human prostatic tissue, whether normal, benign, or malignant. The tissue specificity of PSA makes it a sensitive and specific tumor marker as an aid in management (monitoring) prostate cancer patients and disease progression following surgery or other therapies. PSA in serum exists in several forms including free, uncomplexed PSA and PSA complexed to several protease inhibitors including a-2-macroglobulin, a-1antichymotrypsin (ACT), and a-1-antitrypsin. It should be noted that there are no existing commercial methods that can recognize PSA bound to α-2-macroglobulin. However, it has been demonstrated that the proportion of PSA complexed with ACT increases as a function of the total PSA concentration, and that the majority of immunoreactive PSA in cancer patients is in complex with ACT. The Bayer cPSA Assay uses a monoclonal antibody for capture which recognizes both free and complexed PSA, but which, when bound to free PSA, precludes the binding of other antibodies specific for the free form of PSA. The inclusion of a second, unlabelled monoclonal antibody which is specific for free PSA prevents the binding of free PSA in the cPSA assay and allows measurement of only PSA which is complexed with ACT. cPSA can be used as a single test alternative to free and total PSA in management of patients with CaP.

Here's a summary of the acceptance criteria and study details for the Bayer ADVIA® IMS cPSA assay, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Imprecision: Not explicitly stated as a test set, but the evaluation involved six calibrator levels and commercial controls, with 10 runs performed. Total replicates = 40. Data provenance not specified, likely internal laboratory data.
   • Correlation: Forty-five (45) serum samples and ninety-eight (98) serum samples were used in two separate correlation studies. The values ranged from 0.03 to 69.69 ng/mL and 0.14 to 86.28 ng/mL, respectively. Data provenance not specified, likely internal laboratory data (e.g., from a clinical laboratory or research setting).
   • Serial Monitoring: Two longitudinal patient samples were used. Data provenance not specified but are described as "serial patient monitoring studies."
   • Interfering Substances: A serum pool with a cPSA concentration of about 3.7 ng/mL was used, spiked with various interfering substances.
   • Recovery: Not stated as a specific test set size, but multiple dilutions were evaluated for several "samples" (at least 4 distinct samples with 5 dilutions each).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This device is an in vitro diagnostic (IVD) assay measuring a biomarker. The "ground truth" for its performance is typically established through analytical studies comparing its measurements to a reference method (in this case, the predicate Immuno 1 cPSA Assay) and assessing its precision, linearity, and interference.
   • There is no mention of "experts" in the sense of clinical reviewers or adjudicators for establishing ground truth as one would find in imaging or clinical diagnostic studies. The ground truth refers to the analyte concentration as measured by a established comparator or derived from known standards.

3. Adjudication method for the test set:

   • Not applicable. This is an analytical performance study for an IVD assay, not a study requiring clinical adjudication of patient outcomes or interpretations. The comparison is against the predicate device's measured values.

4. 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 an IVD assay, not an AI-powered diagnostic imaging or interpretation tool that involves human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance data presented (imprecision, correlation, interfering substances, recovery, analytical range, minimum detectable concentration) are all derived from the standalone performance of the ADVIA IMS cPSA assay. The device itself is an automated laboratory analyzer.

6. The type of ground truth used:

   • The primary ground truth for the correlation study was the measurements obtained from the predicate device, Immuno 1 cPSA Assay. This establishes substantial equivalence.
   • For imprecision, the ground truth relates to the consistency of measurements of known calibrators and controls.
   • For interfering substances and recovery, the ground truth relates to expected concentrations after spiking or dilution, and the observed values are compared to these.

7. The sample size for the training set:

   • Not applicable in the context of this 510(k) submission. This is an IVD assay, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The assay is based on established immunodiagnostic principles. Any internal development or optimization of the assay would have been done prior to this submission, but it's not described in terms of a "training set" like an AI model.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for an AI or machine learning model described here. This device relies on chemical and immunological reactions, with calibration performed using known standards.

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