BriefCase-Triage
Aidoc Medical, Ltd.BriefCase-Triage is an AI-powered software designed to analyze CT scans of the cervical spine in adults, helping hospital networks and medical specialists by flagging potential fractures. It provides notifications and preview images of suspected cases, enabling faster prioritization of urgent findings to improve clinical workflow and patient care, while not altering original diagnostic images.
Intended Use
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT scans that include the cervical spine, in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of linear lucencies in the cervical spine bone in patterns compatible with fractures.
Technology
The device is a software package that uses an AI deep learning algorithm to analyze filtered DICOM CT images of the cervical spine on a Linux-based cloud server. It processes images chronologically, detects suspected fractures, and sends notifications with compressed, low-quality grayscale preview images for triage prioritization. It integrates with image communication platforms and operates in parallel with standard image interpretation workflow without altering diagnostic images.
Performance
A retrospective, blinded, multicenter study on 487 CT cases was conducted. Sensitivity and specificity exceeded 80% goals, with sensitivity at 92.1% and specificity at 92.6%. Time-to-notification was significantly faster than predicate devices, averaging 15.1 seconds versus 234 seconds. Performance was maintained across various slice thicknesses and multiple operating points assuring safety and effectiveness in triage workflow.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/19/2024
29 days - 2
FDA Approval
10/18/2024
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Quantification2024 • 510K
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