BriefCase-Triage
Aidoc Medical, Ltd.BriefCase-Triage by Aidoc Medical is an AI-powered software that analyzes CT pulmonary angiography images to detect suspected cases of Central Pulmonary Embolism. It provides notifications and low-quality preview images to assist trained clinicians in prioritizing urgent cases, helping speed up patient care without replacing the standard diagnostic process.
Intended Use
Radiological computer-aided triage and notification software for analysis of CTPA images to assist hospital networks and trained specialists in flagging suspected positive cases of Central Pulmonary Embolism in adults and adolescents 18+.
Technology
The software runs on a Linux-based server in a cloud environment, receiving filtered DICOM images and processing them chronologically using a deep-learning AI algorithm. It provides pop-up notifications with compressed, low-quality preview images for prioritization only. The software integrates with image communication platforms and desktop review applications without altering the original images.
Performance
A retrospective multicenter study on 328 unique patient cases showed sensitivity of 89.2% and specificity of 94.5% for Central PE detection, surpassing an 80% performance goal. Time-to-notification averaged 29.3 seconds, significantly faster than the predicate device at 158.4 seconds, demonstrating effective triage speed enhancement.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/8/2023
1 month - 2
FDA Approval
10/30/2023
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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