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The Bayer Immuno 1™ CA 125 Il Assay is an in vitro device for the quantitative measurement of OC 125 reactive determinants associated with a high molecular glycoprotein in serum of women with primary epithelial invasive ovarian cancer. The CA 125 II Assay is indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. An assav value of greater than 35 UlmL is indicative of residual disease, provided that alternative causes of elevated CA 125 II Assay values can be excluded (refer to "Limitations of the Procedure" section). It is recommended that the assessment and treatment of patients with ovarian cancer and the use of the Bayer Immuno 1 CA 125 II Assay be under the order of a physician trained and experienced in the management of gynecological cancers.

The Bayer Immuno ITM CA 125 II™ Assay is a sandwich immunoassay in which one monoclonal antibody (M11) is conjugated to fluorescein (R1) and a second monoclonal antibody (OC 125) is conjugated to alkaline phosphatase (R2), An Immuno 1 Magnetic Particle coated with anti-fluorescein antibody, the R1 conjugate, and patient sample, calibrator, or control are mixed simultaneously and incubated at 37°C on the system. The R2 conjugate is then added, and binds to the immobilized CA 125 II to form a sandwich immunocomplex on the solid phase. The magnetic particles complexed with the immunological sandwich are then washed to separate unbound molecules, and a colorimetric substrate is added. The rate of conversion of substrate to a compound with absorbance at 405 and 450 mm is measured; the measured rate is proportional to the concentration of CA 125 II antigen in the sample. A cubic-throughzero curve fitting algorithm is used to generate standard curves. The assay uses six calibrators with CA 125 II concentrations of 0, 15, 30, 80, 200, and 500 U/mL.

Here's a summary of the acceptance criteria and study details for the Bayer Immuno 1™ CA 125 II™ Assay, based on the provided text:

Acceptance Criteria and Device Performance for CA 125 II Assay (K964098)

This device is an in vitro diagnostic assay and its performance is evaluated against the predicate device (Centocor CA 125 II™ RIA) and established analytical specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, explicit "acceptance criteria" are not always presented as discrete thresholds, but rather as successful demonstration of performance comparable to the predicate or within established analytical norms.

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

• Clinical Test Set (for sensitivity/specificity as an aid for residual ovarian cancer detection): 48 patients.
  • Data Provenance: From patients with primary epithelial invasive ovarian cancer who completed primary therapy and underwent diagnostic second-look surgery. The location (country of origin) is not explicitly stated, but the study was conducted for FDA submission in the US, suggesting the data is likely from the US or a region compliant with US regulatory standards. The study is prospective in that it compares the Immuno 1 assay results to the outcome of procedures (second-look surgery) for these patients.
• Method Comparison/Concordance Test Set: 703 human serum samples.
  • Data Provenance: Samples from "normal healthy females" (pre- and post-menopausal), "single point ovarian cancer specimens," "lung cancer specimens," "breast cancer specimens," "colorectal cancer specimens," "other cancers," and "benign urogenital disease samples." The samples were sourced from "BioClinical Partners" and "Bayer Diagnostics." Again, specific country of origin is not stated. This appears to be a retrospective collection of samples analyzed prospectively with both methods.

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

• Clinical Test Set Ground Truth: The "diagnostic outcome" of the second-look procedure served as the ground truth. This implies a surgical and/or pathological assessment. The document does not specify the number or qualifications of experts who established this ground truth (e.g., surgeons, pathologists). It only states that the second-look procedure was the diagnostic outcome.

4. Adjudication Method for the Test Set

• Clinical Test Set: The ground truth was established by the "diagnostic outcome of the second look procedure." There is no mention of an adjudication method (e.g., 2+1, 3+1 consensus) for this diagnostic outcome. It is assumed to be the definitive clinical diagnosis.

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

• Not Applicable. This is an in vitro diagnostic device (a laboratory assay for measuring a biomarker in serum), not an AI-powered image analysis or diagnostic assist device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission. The "comparison" is between the new assay and a predicate assay.

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

• Yes, implicitly. The device itself is a standalone laboratory assay. Its performance is measured independently (e.g., sensitivity, specificity, imprecision, linearity). The clinical utility is then assessed by comparing its output (a quantitative CA 125 II value) to clinical outcomes (residual ovarian cancer determined by second-look surgery) and to the predicate device's output. There is no "human-in-the-loop" component in the assay's function; clinicians interpret the assay results in conjunction with other clinical information.

7. The Type of Ground Truth Used

• Clinical Test Set: The ground truth for the clinical study was the diagnostic outcome of the second-look procedure, which represents a definitive clinical and likely pathological assessment for residual ovarian cancer.
• Method Comparison Test Set: The ground truth for the method comparison was the measured CA 125 II values from the predicate device (Centocor CA 125 II™ RIA), as well as the classification of samples (e.g., normal, ovarian cancer, other cancers, benign urogenital disease).

8. The Sample Size for the Training Set

• The document describes the submission of a medical device (an in vitro diagnostic assay) that measures a biomarker. It does not describe a "training set" in the context of a machine learning algorithm or AI. The assay is a chemical and immunological measurement system. Its development would involve internal analytical validation and optimization, but not typically a "training set" like that seen in AI/ML applications.

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

• Not Applicable. As noted above, this device does not utilize a training set in the AI/ML sense. The "ground truth" for the analytical development of the assay (e.g., calibrator values, reference materials) would be established through established laboratory methods and validated reference standards.

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