Hyper Insight - ICH is an AI-powered clinical software tool that analyzes brain CT scans to detect suspected intracranial hemorrhage. It provides timely notifications to medical specialists to prioritize patient care, helping clinicians triage potential emergencies more efficiently. The software serves as a supplementary notification aid rather than a definitive diagnostic tool, enhancing workflow efficiency and supporting faster treatment decisions.
Intended Use
Hyper Insight - ICH is a notification-only workflow tool for trained clinicians to identify patients' brain CT images and share them with medical specialists in parallel with standard patient care workflow. Hyper Insight - ICH uses deep learning-based AI algorithms to analyze images to find suspected intracranial hemorrhage and notifies and shares the findings to medical specialists. Identification of images with suspected intracranial hemorrhage is for notification purposes only, not diagnostic purposes.
Technology
Hyper Insight - ICH is software as a medical device (SaMD) that detects intracranial hemorrhage by analyzing non-contrast CT images. It integrates with third-party worklist applications to receive and send DICOM images and alerts. The device uses deep learning algorithms to analyze CT scans and returns a binary output indicating suspected presence of acute ICH for notification purposes only.
Performance
A retrospective study evaluated the device with 394 brain CT images from 13 clinical sites. The software showed sensitivity of 95.45% and specificity of 98.47%, meeting prespecified performance goals of at least 80%. The AUC was 0.9864, and the average notification time was 16.39 seconds, faster than the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/5/2024
4 months - 2
FDA Approval
7/1/2024
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