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The ADVIA Centaur CA 15-3 assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 15-3 in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP, and ADVIA Centaur XPT systems. When used in conjunction with other clinical and diagnostic procedures, serial testing with the ADVIA Centaur CA 15-3 assay is useful for monitoring the course of disease and therapy in metastatic breast cancer patients, and for detection of recurrence in previously treated Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients. This assay is not intended for use on any other system.

The ADVIA Centaur CA 15-3 assay reagents come in the following configurations: 5 ReadyPack primary reagent packs containing ADVIA Centaur CA 15-3 Lite Reagent, Solid Phase, and Conjugate Reagent, and ADVIA Centaur CA 15-3 Master Curve card (500 tests); 1 ReadyPack primary reagent pack containing ADVIA Centaur CA 15-3 Lite Reagent, Solid Phase, and Conjugate Reagent, and ADVIA Centaur CA 15-3 Master Curve card (100 tests). The ReadyPack consists of ADVIA Centaur CA 15-3 ReadyPack primary reagent pack; Lite Reagent (monoclonal mouse anti-DF3 antibody labeled with acridinium ester), ADVIA Centaur CA 15-3 ReadyPack primary reagent pack; Solid Phase Reagent (monoclonal mouse capture antibody covalently coupled to paramagnetic particles), and ADVIA Centaur CA 15-3 ReadyPack primary reagent pack: Conjugate Reagent (monoclonal mouse anti-115D8 antibody labeled with a thiocarbamate of fluorescein).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: ADVIA Centaur CA 15-3 assay

1. Table of acceptance criteria and the reported device performance:

Note: The document states "The analytical performance data previously reviewed for the ADVIA Centaur CA 15-3 assay continues to apply to this assay." This implies that the change from the predicate device was primarily the addition of plasma sample types, and the acceptance criteria for the original analytical performance characteristics (like assay range, precision within serum, etc.) were already met and considered valid for this modified device. The studies presented here focus on demonstrating equivalence for the new sample types and re-affirming key analytical specifications. The specific numerical acceptance criteria themselves are not explicitly listed but are implied by the successful results of the studies.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Detection Capability: No specific sample size is provided for LoB, LoD, and LoQ determination. The methodology followed CLSI Document EP17-A2. Data provenance is not specified.
• Precision: 80 results per specimen type (Serum A, Serum B, Plasma EDTA, Plasma Heparin, Control 1, 2, 3). No information on data provenance (country, retrospective/prospective).
• Specimen Equivalency:
  • Dipotassium EDTA plasma vs. Serum: 129 samples
  • Lithium Heparin plasma vs. Serum: 108 samples
    No information on data provenance (country, retrospective/prospective).
• Interferences: No specific sample size is given per substance, but results are provided for Dipotassium EDTA and Heparin at two different analyte concentrations. No information on data provenance.

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

This is an in vitro diagnostic test for measuring a tumor marker (CA 15-3). The ground truth for such devices is typically established through reference methods or quantitative chemical analysis, not by human expert interpretation of images or clinical cases. Therefore, the concept of "experts establishing ground truth" in the way it applies to imaging AI or diagnostic algorithms based on interpretation is not relevant here.

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

Not applicable. This is an in vitro diagnostic assay, not a device requiring interpretation or adjudication by multiple human readers.

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 assay, not an AI-powered diagnostic imaging or clinical decision support system that would involve human readers.

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

Yes, the studies presented are for the standalone performance of the ADVIA Centaur CA 15-3 assay. While it is intended for use "in conjunction with other clinical and diagnostic procedures" and for use by healthcare professionals, the performance characteristics tested (precision, detection capability, specimen equivalency, interference) represent the analytical performance of the automated assay itself, without human interpretation as part of the core performance measurement.

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

The ground truth for this type of quantitative assay would inherently be established by the concentration of the analyte (CA 15-3) as measured by a reference method or highly accurate, precisely calibrated laboratory standard. For specimen equivalency, the ground truth is the concentration in serum measured by the same assay, to which the plasma measurements are compared. For interference, it is the known concentration of the analyte without the interferent.

8. The sample size for the training set:

The document describes performance data for the modified device. It states that "The analytical performance data previously reviewed for the ADVIA Centaur CA 15-3 assay continues to apply to this assay." This implies that prior internal validation and possibly external studies for the original device (K012357) served as the "training" or development data. No specific sample size for a training set dedicated to the modified device is provided, as the modifications were largely related to sample types, not a complete re-development of the assay's core principle or algorithm that would necessitate a new, extensive training dataset for an AI model.

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

Given this is an in vitro diagnostic assay, the "ground truth" for the training set (or rather, the development and verification phases of the original assay) would have been established through a rigorous process of:

• Reference materials: Using certified reference materials with known concentrations of CA 15-3.
• Primary reference methods: Comparing to established, highly accurate analytical methods.
• Spiking studies: Adding known amounts of CA 15-3 to samples to assess analytical recovery.
• Clinical correlation: While not a "ground truth" in the analytical sense, the selection of the analyte (CA 15-3) and its clinical cut-offs are derived from extensive clinical studies correlating CA 15-3 levels with disease status and progression in breast cancer patients. This would involve a large number of patient samples with confirmed clinical diagnoses, pathology reports, and known treatment outcomes.

The document primarily focuses on the validation studies performed to support the modified device (addition of plasma sample types) rather than the original development or "training" phases, which would have occurred prior to the predicate device's clearance.

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