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The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

The Access® OV Monitor reagents, calibrators and the Access Immunoassay Systems family comprise the Access Immunoassay System for the quantitative determination of CA 125 antigen in human serum and plasma.

The provided text describes the 510(k) submission for a modification to the Access OV Monitor Assay. The modification is to add a new instrument platform, the Beckman Coulter UniCel™ DxI 800 Access® Immunoassay System. The study conducted aimed to demonstrate that the Access OV Monitor assay on the DxI system is substantially equivalent to the Access OV Monitor assay on the Access 2 system.

Here's an analysis of the acceptance criteria and the study based on the provided information:

1. A table of acceptance criteria and the reported device performance:

The document states: "The Access OV Monitor assay met the established acceptance criteria for method comparison, precision and analytical sensitivity." However, the specific quantitative acceptance criteria and the detailed reported performance values are not provided in this summary.

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

• Sample Size: The document does not explicitly state the sample size used for the test set in the method comparison, precision, or analytical sensitivity studies.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

This information is not applicable as the device is an in-vitro diagnostic (IVD) immunoassay, not an AI or image-based diagnostic requiring expert interpretation for ground truth. The ground truth would typically be established through analytical methods and reference materials.

4. Adjudication method for the test set:

This information is not applicable for an IVD immunoassay. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments by experts, which is not the case here.

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:

This information is not applicable as the device is an IVD immunoassay and does not involve human readers interpreting images with or without AI assistance. The study focuses on the analytical performance of the immunoassay on a new instrument.

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

The study conducted was a standalone performance evaluation of the Access OV Monitor assay on the DxI system, demonstrating its analytical performance without human intervention in the assay's execution, beyond standard lab procedures. The device itself (the immunoassay system) operates without human-in-the-loop performance for result generation.

7. The type of ground truth used:

For method comparison, precision, and analytical sensitivity studies of an immunoassay, the "ground truth" is typically established by:

• Reference Standards/Materials: For analytical sensitivity, known concentrations of the analyte (CA 125 antigen) would be used.
• Predicate Device/Method: For method comparison, results from the legally marketed predicate device (Access OV Monitor Assay on the Access 2 system) would serve as the comparative ground truth.
• Certified Reference Materials: For accuracy or calibration, materials with assigned values are used.

The document does not explicitly state the exact type of ground truth but implies comparison to the predicate device and established analytical methods.

8. The sample size for the training set:

This information is not applicable. The device is an immunoassay system, not an AI/machine learning model that requires a training set in the conventional sense. The "training" of the device involves its design, calibration, and validation as an analytical system.

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

This information is not applicable for the reasons stated above.

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