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The Bayer ADVIA® IMS™ AFP assay is an in vitro diagnostic device intended to quantitatively measure afetoprotein (AFP) in human serum on the Bayer ADVIA IMS system as an aid in the management of nonseminomatous testicular cancer. AFP 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. AFP testing is not recommended as a screening procedure to detect cancer in the general population.

The Bayer ADVIA® IMS™ AFP assay is an in vitro diagnostic device intended to quantitatively measure afetoprotein (AFP) in human serum on the Bayer ADVIA IMS system.

Acceptance Criteria and Study for Bayer ADVIA® IMS™ AFP Assay

This document summarizes the acceptance criteria and the study conducted to demonstrate the safety and effectiveness of the Bayer ADVIA® IMS™ AFP Assay.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ADVIA IMS AFP Assay are primarily established by demonstrating substantial equivalence to the predicate device, Immuno 1 AFP Assay, across various performance metrics. The specific quantitative acceptance criteria are implicitly defined by the reported performance metrics of the predicate device and the observed performance of the new device.

Note on Acceptance Criteria: For this type of diagnostic device, formal, explicit numerical acceptance criteria often aren't stated as "must be less than X" or "must be greater than Y." Instead, the criteria are often qualitative, such as "comparable to the predicate device," "within clinically acceptable limits," or "demonstrates substantial equivalence." The reported performance of the predicate device serves as the benchmark. The study's "conclusion" explicitly states "Performance...is equivalent to the performance of the AFP Assay on the predicate device (Immuno 1) and is within proposed specifications," indicating these metrics were met.

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

• Correlation Study (Regression Analysis):

  • Sample Size: 50 serum specimens.
  • Data Provenance: Not explicitly stated, but clinical specimens are implied for a correlation study comparing two assay methods. The country of origin and retrospective/prospective nature are not specified in the provided text.

• Imprecision Study:

  • Sample Size: Not explicitly stated for the number of replicates or days tested, but typically involves multiple replicates tested over several days. The data provided includes "Level" and "Total CV(%)".
  • Data Provenance: Not specified.

• Interfering Substances Study:

  • Sample Size: Various AFP concentrations (10.2, 19.8, 21.3, 16.4, 14.8 ng/mL) were tested in the presence of specified concentrations of interfering substances. The number of individual samples tested for each substance is not explicitly stated.
  • Data Provenance: Not specified.

• Expected Values (Reference Range Study):

  • Sample Size: 250 healthy individuals.
  • Data Provenance: Not specified, but likely sourced from a local population or established clinical labs.

• Patient Population Distribution Study:

  • Sample Size:
    • Healthy Subjects: 350
    • Testicular Cancer (nonseminomatous): 100
    • Testicular Cancer (mixed germ cell tumor): 46
    • Testicular Cancer (seminomatous): 8
    • Prostate Cancer / Bladder Cancer: 40
    • Lung Cancer: 29
    • Colorectal Cancer: 38
    • Liver Cancer: 67
    • Breast Cancer: 10
    • Cirrhosis: 50
    • Hepatitis: 50
    • Benign Genito-urinary disease: 29
    • Other nonmalignant: 37
  • Data Provenance: "Immuno 1 data on file" is noted for these expected values, suggesting this data was likely pre-existing from studies conducted with the predicate device, or was generated with the predicate and then confirmed with the new device. The country of origin and retrospective/prospective nature are not specified.

3. Number of Experts and Qualifications for Ground Truth

• No "experts" in the traditional sense (e.g., radiologists interpreting images) were used to establish ground truth for the performance studies described. This is a quantitative diagnostic assay, where "ground truth" is typically established by physical measurements, reference methods, or clinical diagnoses.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessment of images or clinical reports by multiple human readers. This submission describes a quantitative assay where results are numerical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This study focuses on the analytical performance of a quantitative assay, comparing it to a predicate device, rather than assessing the performance of human readers with or without AI assistance.

6. Standalone Performance Study

• Yes, a standalone study of the algorithm (assay method) was done. The entire submission details the performance of the ADVIA IMS AFP Assay as a standalone device, directly measuring AFP levels in serum samples. The performance characteristics (imprecision, correlation, interfering substances, analytical range, MDC) are all measurements of the device's inherent analytical capability without human interpretation being part of the primary performance metric being evaluated. The "monitoring data" also shows the device's output over time for individual patients.

7. Type of Ground Truth Used

The "ground truth" for the various studies can be categorized as follows:

• Imprecision: Internal consistency of the device, measured against its own repeated results.
• Correlation: Reference values established by the predicate device (Immuno 1 Assay). The predicate device's measurements serve as the comparator "truth" against which the new device's measurements are compared.
• Interfering Substances: Presence of known concentrations of specific substances in the sample. The "effect" is the deviation from the expected measurement in the absence of the interferent.
• Analytical Range & Minimum Detectable Concentration: Determined through analytical experiments using known concentrations of AFP standards.
• Expected Values/Patient Population Distribution: Clinical outcomes/diagnoses (e.g., healthy subjects, testicular cancer, liver cancer, cirrhosis) were used to characterize patient populations and establish reference ranges. These clinical diagnoses serve as the "ground truth" for understanding the assay's utility in different disease states.

8. Sample Size for the Training Set

• Not applicable. This document describes a traditional in-vitro diagnostic (IVD) assay, not a machine learning or AI-based device that typically requires a large "training set" for model development. The assay's performance is based on chemical reactions and detection methods, calibrated using standards.

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

• Not applicable. As the device is not an AI/ML product, there is no "training set" in that context. The "ground truth" for establishing the assay's analytical characteristics (like analytical range and MDC) is derived from using known concentrations of AFP standards and calibrators. For the clinical utility data (expected values in different patient populations), the ground truth is the established clinical diagnosis of the patients in those cohorts.

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