BriefCase-Quantification
Aidoc Medical, Ltd.BriefCase-Quantification is an AI-powered software that analyzes CT scans of the abdominal aorta to measure its maximum diameter. It helps trained medical specialists by providing preliminary diameter measurements to assist with evaluating normal and aneurysmal abdominal aortas, improving the efficiency of radiological assessments. The software is cloud-based, processes images from DICOM format, and integrates output with PACS for clinician review.
Intended Use
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal aorta, in adults or transitional adolescents aged 18 and older. It assists trained medical specialists by providing maximum abdominal aortic diameter measurements of normal and aneurysmal abdominal aortas and is not intended for post-operative aortas.
Technology
The software uses an AI deep-learning algorithm to analyze filtered DICOM CT images on a cloud-based Linux server. It generates annotated preview images showing the maximum abdominal aortic diameter orthogonal to blood flow and exports results to PACS for review. The system is based on improved training on a larger dataset compared to its predicate device.
Performance
A retrospective, blinded multicenter study on 162 CT cases demonstrated the algorithm's mean absolute error of 1.52 mm compared to radiologist ground truth measurements, meeting its primary endpoint with no significant bias. Performance was comparable to the predicate device (mean absolute error 1.95 mm). The study included diverse clinical subgroups and multiple scanner manufacturers.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/22/2024
23 days - 2
FDA Approval
5/15/2024
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.