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510(k) Data Aggregation
(45 days)
PMA P950011, K965141
The Chiron Diagnostics ACS:180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS 180: Automated Chemiluminescence Systems. The test is intended for use as an aid in monitoring patients previously treated for Stage III breast cancer. Serial testing for CA 27,29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression of disease in response to treatment.
The Chiron Diagnostics ACS:180 BR assay is a fully automated, competitive, chemiluminescent assay. One reagent, designated Lite Reagent, is composed of a mouse monoclonal antibody specific for CA 27.29, labeled with acridinium ester. The antibody used in the assay, MAb B27.29, binds to a peptide epitope in the tandem repeat region of the MUC-1 gene product. The Solid Phase is composed of purified breast cancer antigen (CA 27.29) which is covalently coupled to paramagnetic particles (PMP). The patient serum sample is incubated with both reagents simultaneously for 7.5 minutes. The ACS: 180 system automatically performs the following steps: dispenses sample into a cuvette, dispenses Lite Reagent and Solid Phase and incubates for 7.5 minutes, separates, aspirates and washes the cuvettes, dispenses reagents which initiate the chemiluminescent reaction, reports results. An inverse relationship exists between the concentration of CA 27.29 in a sample and the relative light units (RLU) detected by the system.
Chiron Diagnostics ACS:180 BR - Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state formal "acceptance criteria" in a numerical or target-based format for the clinical performance of the ACS:180 BR. Instead, it presents the assay's performance characteristics and then concludes that these were "substantially equivalent" to the predicate device. Therefore, the "acceptance criteria" can be inferred as achieving substantial equivalence to the predicate device's performance.
| Performance Metric | Inferred Acceptance Criteria (Substantial Equivalence to Predicate Device) | Reported Device Performance (ACS:180 BR) |
|---|---|---|
| For monitoring recurrence (1 Value > ULN): | Similar sensitivity, specificity, PPV, NPV to predicate. | Sensitivity: 60% (39, 79), Specificity: 93% (87, 96), PPV: 60% (39, 79), NPV: 93% (87, 96) |
| For monitoring recurrence (2 Consecutive Values > ULN): | Similar sensitivity, specificity, PPV, NPV to predicate. | Sensitivity: 48% (28, 69), Specificity: 98% (94, 100), PPV: 80% (52, 96), NPV: 91% (85, 95) |
| For managing metastatic disease (Sensitivity to Change): | Similar sensitivity to predicate. | Sensitivity to Change in Disease Status: 73% (58, 85) |
| For managing metastatic disease (Specificity to Change): | Similar specificity to predicate. | Specificity to Change in Disease Status: 71% (53, 85) |
| For managing metastatic disease (PPV to Change): | Similar PPV to predicate. | Positive Predictive Value to Change in Disease Status: 77% (61, 88) |
| For managing metastatic disease (NPV to Change): | Similar NPV to predicate. | Negative Predictive Value to Change in Disease Status: 67% (49, 81) |
| Correlation with Predicate Device (203 specimens): | Strong correlation (e.g., r > 0.90, slope ~ 1, y-intercept ~ 0). | r = 0.96, slope = 1.05, y-intercept = 6 U/mL |
| Correlation with Predicate Device (103 breast cancer specimens): | Strong correlation (e.g., r > 0.90, slope ~ 1, y-intercept ~ 0). | r = 0.96, slope = 1.04, y-intercept = 8 U/mL |
| Analytical Sensitivity | <3.5 U/mL (Inferred from reported value) | <3.5 U/mL |
| Assay Upper Limit of Normal (ULN) | Established through testing healthy volunteers. | 38.6 U/mL (based on 314 healthy volunteers) |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Recurrence Monitoring Study: 162 patients for the primary analysis of clinical performance as an aid in monitoring recurrence. These patients provided 942 specimens.
- Sample Size for Metastatic Disease Management Study: 97 breast cancer patients with metastatic disease. Calculations were based on the 79 patients who had assay levels above the ULN.
- Sample Size for Correlation Study: 203 specimens overall, with a subset of 103 women with histologically confirmed breast cancer.
- Data Provenance: The studies were described as "multicenter-prospective studies" (for recurrence monitoring and metastatic disease management). The specific countries of origin are not explicitly stated, but the submission is to the U.S. FDA by a U.S. company, suggesting North American or international sites. The "healthy volunteer donors" for ULN determination were tested at "three laboratories."
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1. For the recurrence monitoring study, "Breast cancer recurrence was established using clinical symptoms, and/or general or specific imaging techniques; e.g., x-ray, mammogram, magnetic resonance imaging, computerized tomography, ultrasound, bone or liver scan." This indicates a clinical diagnosis process, but no specific adjudication protocol is mentioned.
For the metastatic disease management study, disease progression or regression was used as an endpoint, but the adjudication of these changes is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was described. The device is an in vitro diagnostic test (an automated assay), not an image reading device that would typically involve multiple human readers. The comparison was the performance of the assay against clinical outcome and against a predicate device, rather than human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, the studies presented are for the standalone performance of the ACS:180 BR assay. It's an automated chemiluminescence system measuring a biomarker, so its performance is inherently "algorithm only" in terms of measurement and result reporting. The clinical utility is then evaluated by how well these results correlate with actual disease status.
7. Type of Ground Truth Used
- For Recurrence Monitoring: "Disease recurrence as defined by clinical outcome." This was established using "clinical symptoms, and/or general or specific imaging techniques; e.g., x-ray, mammogram, magnetic resonance imaging, computerized tomography, ultrasound, bone or liver scan." This indicates a combination of clinical follow-up and imaging.
- For Metastatic Disease Management: "Changing disease status" (progression or regression) determined clinically, with a 20% increase in assay levels used as an indication of progressing disease.
- For Specificity (Non-breast malignancies/Other conditions): Diagnosis of the specific malignancy or condition.
- For Correlation with Predicate Device: The value obtained from the predicate device (Biomira TRUQUANT® BR™ RIA).
- For ULN determination: Serum samples from "healthy volunteer donors."
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. The ACS:180 BR is a quantitative immunoassay, not an AI/ML algorithm that is "trained" in the typical sense. The "training" in this context would be the assay development and optimization, which isn't described with a specific dataset size.
9. How Ground Truth for Training Set Was Established
As noted above, a distinct "training set" with established ground truth, as understood in machine learning, is not applicable or described for this type of in vitro diagnostic assay. Instead, the assay is developed based on chemical and biological principles to detect a specific antigen. The performance studies described (clinical performance, analytical sensitivity, specificity, etc.) serve as validation of the assay's accuracy and utility.
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