Elucid FFR-IQ (B.1)
Elucid Bioimaging, Inc.Elucid FFR-IQ is an AI-powered software that analyzes coronary CT angiography images to estimate blood flow and help clinicians evaluate the presence and impact of coronary artery disease, providing valuable support in making clinical decisions without invasive procedures.
Intended Use
Elucid FFR-IQ is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable patients with known or suspected coronary artery disease. It provides FFR-CT (CT-derived FFR) values estimated from coronary CTA images using AI-enabled algorithms. FFR-IQ is intended to support the functional evaluation of coronary artery disease.
Technology
FFR-IQ integrates anatomy and biology data, such as plaque composition and amount, to estimate FFR-CT values from static coronary CTA images using deep learning neural networks. The analysis relies on 3D segmentation results from Plaque-IQ, an AI-enabled algorithm, to assess FFR-CT values along the coronary tree.
Performance
The device was validated through extensive nonclinical software verification, cybersecurity, human factors, and usability testing. Clinical validation was provided by the ELUCIDATE (NCT06018194) retrospective multicenter study analyzing 491 vessels across 347 patients, comparing FFR-IQ simulated FFR-CT against invasive FFR. The study met sensitivity and specificity endpoints, with overall sensitivity of 92.2% and specificity of 93.1%.
Predicate Devices
No predicate devices specified
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