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The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for patient CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.

The Access BR Monitor reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of CA 15-3 antigen in human serum and plasma.

Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter Access BR Monitor, based on the provided document:

Acceptance Criteria and Device Performance

Study Information

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

• Methods Comparison (Analytical):
  • Sample Size: 435 samples
  • Data Provenance: Human serum samples. No country of origin is explicitly stated, but clinical studies often involve multi-site collection, implicitly from the country of the submitting company (USA) or collaborating regions. The sample type (serum) is mentioned, indicating laboratory-based retrospective analysis.
• Clinical Studies (Serial Monitoring):
  • Sample Size: The document refers to "subjects" and "samples" from a serial monitoring study. The exact number of subjects or individual samples (visit pairs) used for the clinical agreement and concordance calculations (e.g., 83.8% positive agreement, 52.9% positive concordance) is not explicitly stated as a single number for each metric, but it refers to the "serial monitoring study."
  • Data Provenance: Samples from subjects diagnosed with breast cancer, monitored over the course of disease management. This indicates prospective collection relative to the disease course, but the analysis described would be retrospective with respect to the study endpoint. Country of origin not specified.

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

• The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. For cancer management studies, clinical ground truth would typically be established by oncologists, pathologists, and other medical specialists, but this information is not provided.
• The "Least Significant %Change (LS %Change)" analysis compared the device's performance against "clinical status" (classified as "Progression" or "No Progression"), which would implicitly rely on expert clinical assessment, but the details are absent.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• The document does not describe any explicit adjudication method for establishing ground truth, such as a consensus process among multiple experts. The reliance is generally placed on the "predicate device" for comparative agreement or "clinical status" for concordance, which would have had their own "ground truth" methods in their original context.

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 device is an immunoassay system (a laboratory diagnostic test for measuring a biomarker, CA 15-3), not an imaging or pathology device that typically involves "human readers" or AI assistance in interpretation in the MRMC sense. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable to this type of device and was not performed or reported.

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

• Yes, the performance presented in the "Summary of Analytical Studies" and "Summary of Clinical Studies" pages all represent standalone (algorithm only) performance of the Access BR Monitor assay. This is an automated immunoassay system that quantitatively measures CA 15-3 levels. Its output is the CA 15-3 concentration, which is then used by clinicians for patient management. There is no human "reading" of an image or pattern that is then assisted by an AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Analytical Studies:
  • For imprecision, sensitivity, and dilution recovery, the ground truth is based on reference materials, spiked samples, and controlled dilutions, which are standard laboratory validation methods.
  • For methods comparison, the ground truth for comparison was the predicate device's measurements (Abbott AxSYM® CA 15-3™).
• Clinical Studies:
  • For relative sensitivity/specificity and agreement, the ground truth was the predicate device's classification (based on its URL).
  • For clinical sensitivity/specificity related to disease status, the ground truth was clinical status ("Progression" or "No Evidence of Disease"), which would be determined by a combination of clinical assessment, imaging, and possibly pathology, though not detailed in this document.

8. The sample size for the training set:

• The document does not provide information on a "training set" for the Access BR Monitor assay, as it is a quantitative immunoassay with established biochemical principles, not a machine learning or AI algorithm in the contemporary sense that requires explicit data training. The "development" of such assays involves reagent formulation, calibration, and optimization rather than machine learning on a dataset.

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

• As explained above, the concept of a "training set" in the context of machine learning and its corresponding ground truth establishment is not applicable to this immunoassay device as described in the provided 510(k) summary. The development process would have involved internal R&D and validation using known samples and established analytical methods.

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