BriefCase
Aidoc Medical, Ltd.BriefCase is a software device that uses artificial intelligence to analyze chest X-ray images for signs of pneumothorax. It notifies trained medical specialists of suspected positive cases via a desktop app to help prioritize patient care. The software works alongside standard clinical workflows without altering the original images or diagnostic process.
Intended Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of Chest X-Ray cases in adults or transitional adolescents aged 18 and older. The device assists hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspect positive cases with Pneumothorax findings.
Technology
BriefCase consists of three modules: Aidoc Hospital Server (image acquisition), Aidoc Cloud Server (image processing), and Aidoc Worklist Application (workflow integration and notification). The software uses an AI deep learning algorithm to analyze filtered and de-identified DICOM images and passively notify suspect cases in a standalone desktop app without modifying the original images.
Performance
Performance was evaluated in a multicenter, retrospective blinded study of 619 chest X-ray cases, achieving AUC of 0.969, sensitivity of 94.2%, and specificity of 90.8% for pneumothorax detection. Time-to-notification was 13.1 seconds, comparable to predicate device. The device met all pre-specified performance goals, supporting its safety and effectiveness in aiding triage.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/23/2021
2 months - 2
FDA Approval
3/14/2022
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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