FFRct

FFRct v 2.18 is a coronary physiologic simulation software that non-invasively assesses coronary artery disease by creating a 3D model from patient CT scans and simulating blood flow to derive FFRct values. This technology aims to provide clinicians with a functional evaluation of coronary lesions, supporting diagnostic assessment when used with other clinical information.

FFRct v 2.18 is a coronary physiologic simulation software designed for the clinical quantitative and qualitative analysis of coronary artery disease in clinically stable, symptomatic patients. It utilizes previously acquired Computed Tomography (CT) DICOM data to generate a patient-specific 3D computer model of the coronary arteries from static CT images. The primary purpose of this software is to provide a non-invasive method for the functional evaluation of coronary arteries, aiding clinicians in their diagnostic process. The core science of the device involves using this 3D model to simulate hemodynamic parameters such as pressure, velocity, and blood flow, from which a mathematically derived quantity, FFRct, is computed. The device's performance characteristics, including its consistency, have been assessed through validation studies like stress and repeatability testing performed on its predicate. The resulting FFRct values and associated functional information are presented graphically and textually to qualified clinicians, intended to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests to support the evaluation and assessment of coronary artery disease. Version 2.18 of the software focuses on clarifying the product boundary at the application programming interface, without altering the fundamental functionality, architecture, or design.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What is the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of FFRct derived from this software compared to invasive FFR measurements across different coronary lesion severities and locations?; How does the FFRct software account for variations in patient-specific physiological parameters (e.g., myocardial mass, microvascular resistance, baseline coronary flow) that are not directly captured in static CT images?; What are the specific image quality requirements for the input CT DICOM data to ensure reliable and accurate FFRct calculations, and how does the software handle suboptimal image quality?; Are there specific patient populations or coronary anatomies (e.g., heavily calcified vessels, diffuse disease, prior stents or bypass grafts) where the performance or applicability of FFRct v 2.18 is limited or requires special consideration?; Beyond the API boundary clarification, what were the detailed results of the stress testing and repeatability testing referenced for the predicate device that ensure the consistent performance of FFRct v 2.18?