BriefCase
Aidoc Medical, Ltd.BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes frontal chest X-rays to detect and flag cases where an endotracheal tube (ETT) is improperly positioned relative to the carina. It assists hospital networks and trained specialists by prioritizing worklists to enable quicker review of potentially urgent cases. The software operates alongside standard care without altering original images, providing early alerts that help clinicians review and manage patient care more efficiently.
Intended Use
BriefCase is a radiological computer-aided triage and notification software indicated for use in the analysis of frontal chest X-ray (CXR) images 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 communicating suspected positive cases of vertically malpositioned endotracheal tube (ETT) in relation to the carina.
Technology
BriefCase software integrates an AI algorithm running on a Microsoft Windows server with modules for image acquisition, cloud-based processing, and desktop workflow integration. It processes DICOM images, filtering and de-identifying them, then analyzes each series chronologically to detect suspect cases of malpositioned ETT. Notifications are sent to a desktop application that displays flagged cases with compressed preview images for prioritization without altering original diagnostic images.
Performance
A retrospective multicenter study with 921 cases from 5 US clinical sites assessed BriefCase's ability to detect vertically malpositioned ETT versus expert radiologist ground truth. Sensitivity was 86.81% and specificity 92.02%, exceeding the 80% performance goal. Time-to-notification was averaged at 4.93 minutes versus 157 minutes for standard-of-care image review, demonstrating effective triage acceleration. Additional performance metrics including PPV, NPV, likelihood ratios, and patient demographics were reported.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/6/2022
6 months - 2
FDA Approval
11/18/2022
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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