Annalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd.Annalise Enterprise CTB Triage Trauma is an AI software tool designed to analyze non-contrast brain CT scans and assist clinicians by prioritizing cases with features suggestive of mass effect. It integrates with image and order management systems to notify users for earlier review, improving workflow efficiency without replacing clinical decision-making.
Intended Use
A device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of mass effect. It analyzes non-contrast brain CT studies using an AI algorithm and provides study-level output to order and imaging management systems for worklist prioritization or triage.
Technology
Software workflow tool using a convolutional neural network AI algorithm trained via deep learning on diverse non-contrast brain CT data. Interfaces with PACS/RIS to process studies and inject prioritization notifications into worklists parallel to standard clinical workflow.
Performance
The device performance was validated in a standalone retrospective study with 626-762 adult brain CT cases, annotated by board-certified neuroradiologists, showing high sensitivity (up to 97%) and specificity (up to 92.9%) for detecting mass effect. Triage effectiveness testing demonstrated turnaround time comparable to predicate devices, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/12/2023
4 months - 2
FDA Approval
9/22/2023
Other devices from Annalise-AI Pty Ltd.
- Annalise Enterprise CTB Triage Trauma2023 • 510K
- Annalise Enterprise CTB Triage-OH2023 • 510K
- Annalise Enterprise CTB Triage Trauma2023 • 510K
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