JBS-LVO is an AI-powered radiological software tool designed to analyze CT angiograms of the brain to detect suspected large vessel occlusions (LVOs). It notifies neurovascular specialists quickly via mobile app notifications to aid in rapid patient triage, supporting timely treatment decisions. The software provides compressed preview images for informational purposes, while diagnosis is made by specialists reviewing full-resolution scans.
Intended Use
JBS-LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. It analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist of suspected large vessel occlusion, recommending review of those images. Preview images are compressed and for informational purposes only.
Technology
The device uses a locked AI software algorithm employing a convolutional neural network (CNN) hosted on a server to automatically analyze brain CTA images for suspected LVOs in terminal ICA and MCA-M1 segments. It integrates with hospital PACS systems using DICOM and sends notifications via a mobile app with compressed preview images. It also includes an advanced 'Critical Pathway' feature for real-time patient care management and communication.
Performance
Performance validation testing shows that JBS-LVO achieves high sensitivity (91.8%) and specificity (92.8%) in detecting LVOs compared to board-certified neuroradiologist ground truth. The time from CTA acquisition to notification averages 2.95 minutes, meeting or exceeding predicate devices. Testing demonstrated safety and effectiveness comparable to predicate devices (Viz LVO K223042 and Rapid LVO K221248).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/24/2024
4 months - 2
FDA Approval
9/27/2024
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