CINA-CSpine
Avicenna.AICINA-CSpine by Avicenna.AI is a radiological computer-assisted triage and notification software that uses AI algorithms to analyze cervical spine CT scans for suspected acute fractures. It helps hospital networks and trained physicians by flagging potential fracture cases and prioritizing image review, enabling faster and more efficient diagnosis and patient care. It operates alongside the standard care workflow without altering original images, providing notifications with preview images for informational purposes.
Intended Use
CINA-CSpine is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images. It assists hospital networks and trained physician specialists by flagging and communicating suspected positive findings compatible with acute cervical spine fractures, including non-displaced fracture lines and displaced fracture fragments. It uses AI to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation. It is not designed to detect vertebral compression fractures, does not alter original images, and is not intended as a diagnostic device. Results are used to assist with triage and prioritization based on professional judgment.
Technology
The device processes cervical spine CT scans using deep learning models trained on over 1,300 cases from multiple international sites and scanner types. It runs on standard servers/workstations, integrates with the CINA Platform or other medical image communication devices, and receives DICOM images which it analyzes sequentially to detect suspected cervical spine fractures. Notifications with compressed preview images are sent to a worklist application for clinician review. The device operates in parallel to standard care without altering original images or workflow.
Performance
Performance validation included a retrospective, multicenter, multinational, blinded study on 328 clinical cases, achieving sensitivity of 90.3% and specificity of 91.9% in detecting cervical spine fractures, comparable to the predicate device. The mean time-to-notification was approximately 2.9 minutes for all cases and 2.8 minutes for true positives, faster than the predicate device. Software verification and validation confirmed compliance with DICOM standards and met all performance requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/5/2024
5 months - 2
FDA Approval
9/12/2024
Other devices from Avicenna.AI
- CINA-VCF2024 • 510K
- CINA-ASPECTS2024 • 510K
- CINA-iPE2024 • 510K
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