BriefCase-Quantification
Aidoc Medical, Ltd.BriefCase-Quantification is an AI-based software that analyzes contrast-enhanced CT scans to measure aortic diameters at key anatomical landmarks, helping clinicians assess normal and aneurysmal aortas. It processes CT images in a cloud environment, produces measurement results for review, and is intended to assist but not replace radiologist evaluations.
Intended Use
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta in adults or transitional adolescents aged 18 and older. It assists hospital networks and trained medical specialists by providing aortic diameter measurements across the aorta to evaluate normal and aneurysmal aortas, but is not intended for evaluating post-operative aortas.
Technology
The software operates as a single AI-based algorithmic module running on a Linux-based cloud server. It receives filtered DICOM CT images, applies deep learning algorithms to measure the maximum aortic diameter and landmarks, and outputs measurement images and tabular results for review through integrated image communication platforms and PACS systems. The measurements are unofficial and require radiologist review.
Performance
A multicenter, retrospective, blinded study of 212 contrast-enhanced CT cases demonstrated the algorithm achieved a mean absolute error of 1.88 mm compared to ground truth measurements by US board-certified radiologists. This performance met the pre-specified endpoint and was comparable to the predicate device. Bland-Altman analysis showed minimal bias. Clinical subgroups included aneurysm, atherosclerosis, dissection, among others.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/26/2024
3 months - 2
FDA Approval
11/22/2024
Other devices from Aidoc Medical, Ltd.
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Quantification2024 • 510K
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