(7 days)
The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis.
The CorVista® System is a non-invasive medical device system comprised of several hardware and software components that are designed to work together to allow a physician to evaluate the patient for the presence of cardiac disease, or cardiac disease indicators, using a static detection algorithm. The CorVista System has a modular design, where disease-specific "Add-On Modules" will integrate with a single platform, the CorVista Base System, to realize its intended use. The CorVista Base System is a combination of hardware, firmware, and software components with the functionality to acquire, transmit, store, and analyze data, and to generate a report for display in a secure web-based portal. The architecture of the CorVista Base system allows for integration with indication-specific "Add-Ons" which perform data analysis using a machine learned detection algorithm to indicate the likelihood of specific diseases at point of care. The CAD Add-On indicates the likelihood of significant Coronary Artery Disease (CAD). The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis.
Here's a breakdown of the acceptance criteria and the study proving the CorVista® System meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state pre-defined acceptance criteria in a quantitative format (e.g., "Sensitivity >= X%"). Instead, it presents the device's performance results and implies that these results were deemed acceptable for substantial equivalence to the predicate device. The comparison to CCTA's "rule out performance" suggests a benchmark, but not a strict acceptance criterion.
| Performance Metric | Reported Device Performance (CorVista® System) | Implicit Acceptance Criteria (based on text) |
|---|---|---|
| Sensitivity | 88% | Comparable to rule out performance of coronary computed tomography angiography (CCTA) |
| Specificity | 51% | Comparable to rule out performance of coronary computed tomography angiography (CCTA) |
| AUC-ROC (Area Under the Receiver Operating Characteristic Curve) | 0.80 | Acceptable performance for aiding diagnosis and comparable to CCTA rule-out performance |
| Repeatability of CAD Score | Demonstrated acceptable results | "produces CAD score results that are both repeatable and repeatable" |
| Reproducibility of CAD Score | Demonstrated acceptable results | "produces CAD score results that are both repeatable and reproducible" |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: N = 1,816 subjects.
- Population A (CAD+ for Sensitivity Testing): Number not specified, but this population was evaluated for sensitivity.
- Population B (CAD- for Specificity Testing): Number not specified, but this population was evaluated for specificity.
- Data Provenance: Prospective, multicenter, non-randomized, repository study. The text does not explicitly state the country of origin, but given the FDA submission, it implicitly refers to data collected in the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The text states that the ground truth for CAD was established via "invasive catheterization (ICA)" or "core-lab adjudicated CTA."
- Number of Experts: Not explicitly stated for ICA or CTA adjudication.
- Qualifications of Experts: It implies that medical professionals performed the ICA, and a core-lab performed the CTA adjudication. The specific qualifications (e.g., number of years of experience for radiologists or cardiologists performing these procedures/adjudications) are not detailed.
4. Adjudication Method for the Test Set
The adjudication method for the ground truth was:
- For ICA: Clinical outcome from invasive coronary angiography. This is a direct, invasive diagnostic procedure.
- For CTA: "Core-lab adjudicated CTA." This implies a standardized process by a specialized lab, likely involving multiple readers or a defined quality control process, but the specific multi-reader method (e.g., 2+1, 3+1) is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not explicitly stated to have been done for human readers with and without AI assistance to assess improvement. The study described focuses on the standalone performance of the CorVista System compared to established diagnostic methods (ICA/CTA). The device is intended to be an "aid in diagnosis" used "in conjunction with their clinical judgment," but the study design presented does not evaluate the human-AI interaction in a comparative effectiveness study setting.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The described clinical testing focuses on the algorithm's performance in indicating the likelihood of significant CAD by comparing its predictions to objective ground truth (ICA/CTA results). The reported sensitivity, specificity, and AUC-ROC are measures of the algorithm's standalone performance.
7. The Type of Ground Truth Used
- Objective Clinical Data / Outcomes Data: The ground truth for the test set was established by:
- Invasive Coronary Angiography (ICA): This is considered a gold standard for diagnosing CAD.
- Core-lab Adjudicated Coronary Computed Tomography Angiography (CTA): This is another strong diagnostic imaging modality, with the "core-lab adjudicated" aspect indicating a high level of rigor in interpretation.
These methods directly determine the patient's actual CAD classification (CAD+ or CAD-).
8. The Sample Size for the Training Set
- The text states the ground truth for the "Model Training and Validation" was "Guideline-driven ground truth via invasive catheterization or core-lab adjudicated CTA." However, the specific sample size for the training set is not provided. The N=1,816 refers to the validation population (test set) used for performance testing.
9. How the Ground Truth for the Training Set Was Established
- The ground truth for model training (and validation) was established using "Guideline-driven ground truth via invasive catheterization or core-lab adjudicated CTA." This implies that the same rigorous, objective diagnostic methods used for the test set's ground truth were also used to label the data utilized during the training and internal validation phases of the algorithm development.
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