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The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to provide a binary output indicating the likelihood of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension. 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 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 Cor Vista 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 PH Add-On indicates the likelihood of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension. 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 device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance metrics, which the document states "passed the pre-specified secondary endpoint."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: N = 386 subjects. These subjects were divided into Population A (elevated mPAP population for Sensitivity Testing) and Population B (non-elevated mPAP population for Specificity Testing).
• Data Provenance: The study was a prospective, multicenter, non-randomized, repository study. The document does not explicitly state the country of origin, but "Analytics for Life, Inc." is located in Toronto, ON, Canada, which might suggest Canadian or North American centers.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Ground Truth Establishment: Ground truth was established via "invasive right heart catheterization (RHC)" and "core lab adjudicated Transthoracic echocardiogram (TTE)."
• Number and Qualifications of Experts:
  • For RHC: Not specified, but generally performed by interventional cardiologists or pulmonologists.
  • For TTE: "Core lab adjudicated." The number of experts involved in the core lab adjudication and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text.

4. Adjudication Method for the Test Set

The document states "core lab adjudicated TTE" was used. The specific adjudication method (e.g., 2+1, 3+1) is not specified.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study comparing human readers with AI vs. without AI assistance was not explicitly mentioned or described in the provided text. The study focused on the standalone performance of the CorVista System.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the described clinical testing evaluates the standalone performance of the CorVista System with PH Add-On. The results (sensitivity, specificity, NPV, AUC-ROC) are for the algorithm's prediction compared to the established ground truth. The device is intended to be used "in conjunction with their clinical judgment," but the performance metrics provided are for the algorithm's direct output.

7. The Type of Ground Truth Used

The ground truth used was guideline-driven ground truth via invasive catheterization (Right Heart Catheterization for elevated mPAP) or core-lab adjudicated Transthoracic echocardiogram (TTE) for non-elevated mPAP. This combines a definitive invasive measure with an expert-adjudicated non-invasive imaging modality.

8. The Sample Size for the Training Set

The sample size for the training set is not specified in the provided text. The document refers to model training and validation but only provides details about the clinical validation (test set) population.

9. How the Ground Truth for the Training Set Was Established

The document states: "Guideline-driven ground truth via invasive catheterization or core-lab adjudicated TTE." This method described for ground truth establishment for the test set is also stated as the method for "Ground Truth for Model Training and Validation," implying the same approach was used for the training data, although specific details on how this was applied to the training set are not elaborated upon.

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