Viz SDH
Viz.ai, Inc.Viz SDH is an AI-driven software designed to analyze non-contrast CT scans of the head to detect subdural hemorrhages. It provides rapid notifications of suspected cases to neurovascular or neurosurgical specialists through a mobile application, improving workflow efficiency and potentially expediting patient care decisions. The system does not replace diagnostic evaluation but serves as a parallel workflow triage tool to alert specialists early.
Intended Use
Viz SDH is a notification-only, parallel workflow tool for hospital networks and trained clinicians to identify and communicate images with suspected subdural hemorrhage to specialists, independent of standard of care workflow.
Technology
Viz SDH includes an AI/ML software algorithm hosted on Viz.ai servers that analyzes non-contrast head CT images for subdural hemorrhage and sends notifications to specialists via a mobile app with non-diagnostic image preview capability. The mobile module integrates with the Viz VIEW non-diagnostic DICOM viewer.
Performance
The device was tested on 542 non-contrast CT scans from three US clinical sites, with a sensitivity of 94% and specificity of 92% for detecting subdural hemorrhage. The area under the ROC curve was 0.96. Average notification time was approximately 1.15 minutes, comparable to a predicate device. Performance stratified by site, age, gender, hemorrhage type, scanner manufacturer/model, and slice thickness showed consistent results meeting preset goals.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/16/2022
5 months - 2
FDA Approval
7/25/2022
Other devices from Viz.ai, Inc.
- Viz HDS, Viz Volume Plus, Viz ICH+2024 • 510K
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- Viz AAA2023 • 510K
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