CINA-iPE
Avicenna.AICINA-iPE is an AI-powered software that analyzes contrast-enhanced CT scans (not dedicated CTPA) to help detect incidental pulmonary embolisms. It flags suspected positive cases in real-time to assist radiologists in prioritizing patients and improving workflow efficiency. It operates alongside standard care without altering original images and provides informative preview notifications but does not replace diagnostic review.
Intended Use
CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for clinical indications other than pulmonary embolism suspicion, including at least part of the lung. It assists hospital networks and trained radiologists by flagging suspected incidental Pulmonary Embolism (iPE) findings to improve workflow triage. Intended for adults and transitional adolescents (18-21). It uses AI to analyze images and highlight suspected iPE cases in a standalone app parallel to standard care. Not designed to detect PE in subsegmental arteries. Notifications include compressed preview images for informational purposes only and are not for diagnostic use.
Technology
CINA-iPE runs on standard server/workstation, integrates with the CINA Platform or other medical image communication devices, and uses deep learning models trained on 5,429 multi-scanner cases to detect incidental pulmonary embolisms on contrast-enhanced CT images. It processes DICOM images and sends flagged notifications to worklist applications for radiologist prioritization, providing unannotated compressed preview images marked 'not for diagnostic use'. It does not alter original images and operates in parallel with standard of care workflows.
Performance
Performance testing included retrospective, multicenter, blinded studies on 381 anonymized clinical cases (47.5% positive iPE). The device showed sensitivity of 87.8% [95% CI: 82.2%-92.2%] and specificity of 92.0% [95% CI: 87.3%-95.4%], achieving the 80% performance goal and comparable to predicate device BriefCase. Time-to-notification was 1.5 minutes mean for CINA-iPE versus 4.7 minutes for predicate, showing effective triage. Testing accounted for multiple scanners and patient demographics.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/15/2023
2 months - 2
FDA Approval
3/13/2024
Other devices from Avicenna.AI
- CINA-CSpine2024 • 510K
- CINA-VCF2024 • 510K
- CINA-ASPECTS2024 • 510K
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