CINA-VCF
Avicenna.AICINA-VCF is an AI-powered software device designed to analyze chest and abdominal CT scans in patients aged 50 and above to identify suspected vertebral compression fractures. It operates alongside standard imaging workflows to prioritize and notify clinicians of potentially positive cases, helping improve triage speed and efficiency without altering original images or serving as a diagnostic tool itself.
Intended Use
CINA-VCF is a radiological computer aided triage and notification software indicated for use in patients aged 50 years and over undergoing non-enhanced or contrast-enhanced CT scans which include the chest and/or abdomen. It assists hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCF) findings using an AI algorithm.
Technology
CINA-VCF runs on standard servers and integrates with the CINA Platform or other medical image communication systems. It receives and processes DICOM CT images using AI deep learning models trained on a large, multinational dataset to detect vertebral compression fractures from T1 to L5 vertebrae. It utilizes additional models to locate spine anatomy and exclude vertebrae with vertebroplasty or orthopedic material. Notifications and previews of suspect cases are provided without altering original images.
Performance
The device was validated with a blinded, multicenter study on 474 CT cases (180 positive for VCF) from US and international sites. It showed a ROC AUC of 0.974 exceeding the performance goal, with sensitivity of 95.2% and specificity of 92.9%. The time-to-notification mean was ~23.4 seconds, notably faster than the predicate device. Software verification and validation testing confirmed all design requirements were met.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/5/2024
2 months - 2
FDA Approval
5/31/2024
Other devices from Avicenna.AI
- CINA-CSpine2024 • 510K
- CINA-ASPECTS2024 • 510K
- CINA-iPE2024 • 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.