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The IMx® CA 15-3™ assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of CA 15-3 assay values in human serum and plasma (EDTA) to aid in the management of Stage II and III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer.

IMx CA 15-3 is a microparticle enzyme immunoassay for the quantitative measurement of CA 15-3 assay values in human serum and EDTA plasma on the IMx System. IMx CA 15-3 employs Abbott Calibrators and Controls.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

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

   • Substantial Equivalence Study (IMx CA 15-3 vs. TRUQUANT BR RIA):
     • Linear Regression: 561 specimens with IMx CA 15-3 values ranging from 4.0 to 246.7 U/mL.
     • ROC Analysis: 160 apparently healthy females, 30 benign breast patients, 228 malignant breast patients (total 418 subjects).
     • Concordance: 160 apparently healthy females, 30 benign breast patients, 228 malignant breast patients, and 629 total subjects (the 629 total subjects likely include the previously mentioned groups and potentially additional ones for the overall concordance calculation).
     • Serial Tracking: 24 malignant breast patients.
   • Blinded Study (AxSYM CA 15-3 vs. TRUQUANT BR RIA):
     • 79 Stage II and Stage III breast cancer patients.
     • 359 specimens from 77 of the evaluable patients for concordance and sensitivity/specificity at relapse.
   • Comparison Study (IMx CA 15-3 vs. AxSYM CA 15-3):
     • 2337 specimens with IMx CA 15-3 values ranging from 3.0 to 250.0 U/mL.
   • Data Provenance: Not explicitly stated but clinical specimens from patients with breast cancer, benign breast conditions, and apparently healthy individuals. Given the context of a 510(k) submission, it's highly likely to be retrospective analysis of collected human serum and EDTA plasma samples. Country of origin is not specified.

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

   • Not applicable/Not mentioned. For an immunoassay device, "ground truth" is typically established by patient diagnosis (e.g., "malignant breast cancer patient," "benign breast patient," "apparently healthy female") and potentially clinical outcomes (e.g., "relapse" for serial tracking of Stage II/III patients), not by expert interpretation of images or other subjective data. The reference values for the assays are predetermined cut-offs.

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

   • Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used for subjective diagnostic tasks (e.g., image interpretation) where multiple human experts provide opinions that need reconciliation to establish ground truth. This is an immunoassay, and the ground truth relies on physician diagnoses and clinical status.

4. 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 a submission for an in vitro diagnostic (IVD) immunoassay device, not an AI-assisted diagnostic tool that helps human readers interpret data. Therefore, an MRMC study and analysis of human reader improvement with/without AI assistance are not relevant.

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

   • Yes, the performance characteristics (e.g., correlation, sensitivity, specificity, dynamic range) represent the standalone performance of the IMx CA 15-3 assay in comparison to the predicate device and another Abbott assay. The device itself is an automated immunoassay system that provides a quantitative result.

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

   • The ground truth for the classification studies (ROC, sensitivity/specificity, concordance) appears to be based on clinical diagnosis (e.g., "malignant breast patients," "benign breast patients," "apparently healthy females") and for the serial tracking, it's based on clinical outcomes/status (e.g., "relapse" in Stage II and III breast cancer). For the linear regression and overall correlation, the ground truth is the quantitative measurement provided by the predicate immunoassay (TRUQUANT BR RIA) or another Abbott immunoassay (AxSYM CA 15-3).

7. The sample size for the training set:

   • Not explicitly mentioned. For IVD submissions, internal method development and optimization would constitute a "training" phase, but specific regulated training set sizes are typically not reported in the 510(k) summary as they are for AI/ML devices. The "test sets" described above are used for performance validation against the predicate.

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

   • Not explicitly mentioned. Similar to the test set, it would have been established through clinical diagnoses and comparison to existing reference methods during assay development.

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