StrokeSENS LVO
Circle Neurovascular Imaging, IncStrokeSENS LVO is software that uses AI to analyze CT angiograms of the head to identify suspected large vessel occlusions, which can cause strokes. It assists healthcare providers by flagging potential LVO cases and sending notifications to specialists in near real-time, helping prioritize urgent cases and improve workflow efficiency. The software does not alter the original images and is intended to be used alongside existing diagnostic workflows.
Intended Use
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images. It sends notifications to clinicians of suspected LVO that requires review.
Technology
StrokeSENS LVO consists of a DICOM-compliant software system with two main components: a Processing Engine that analyzes CTA head images to detect LVO using a machine learning binary classifier, and a compatible Radiological Software Platform that handles image retrieval and notification workflows. The system outputs a binary positive/negative result and notifies clinicians via email or workstation for triage purposes.
Performance
Performance testing included a retrospective study on 400 independent CTA studies with a balanced prevalence of LVO, achieving 89.4% sensitivity and 87.4% specificity for detecting LVO. The device processes images rapidly, with an average notification time of 0.75 minutes, exceeding the goal of under 5 minutes. Software verification followed ISO and FDA guidelines ensuring safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/20/2021
2 months - 2
FDA Approval
10/14/2021
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