EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)
Ever Fortune.Ai, Co., Ltd.The EFAI Neurosuite CTA LVO Assessment System is an AI-powered tool designed to help clinicians quickly identify and prioritize cases of suspected large vessel occlusion (LVO) in head CT angiography scans. By flagging these urgent cases, the software streamlines workflow and enables faster evaluation for possible stroke, supporting better patient outcomes.
Intended Use
Radiological computer aided triage and notification software indicated for use in the analysis of CTA head images, to assist clinicians in workflow triage by flagging and communication of suspected positive ICA, MCA-M1, or MCA-M2 Large Vessel Occlusion (LVO) findings.
Technology
A software-only system that uses deep learning (artificial intelligence) to analyze contrast-enhanced head CTA scans for possible large vessel occlusion, providing passive notifications through PACS/workstation to facilitate case triage. Does not annotate images or highlight locations and does not alter original images.
Performance
Performance was validated through software verification/validation and a retrospective, blinded multicenter clinical study of 313 CTA head cases, demonstrating high sensitivity (0.96), specificity (0.94), and rapid system processing time (mean 3.03 minutes). Subgroup analyses showed consistent performance across demographic and imaging acquisition variables.
Predicate Devices
No predicate devices specified
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