Intended Use

a2z-Unified-Triage is a radiological computer-aided triage and notification software indicated for use in the analysis of abdominal/pelvic CT images in adults aged 22 and older to assist hospital networks and trained specialists in workflow triage by flagging and communicating suspected positive cases of seven specified abdominopelvic findings.

Technology

The device uses AI deep learning models analyzing CT studies to detect presence of seven abdominopelvic findings, returning binary outputs with key DICOM image slices for informational purposes. It supports cloud-based and on-premises deployment, integrates with clinical imaging systems for workflow prioritization, and operates in parallel with standard care without altering original images.

Performance

Clinical performance testing on 675 diverse abdominal/pelvic CT cases demonstrated high accuracy with sensitivity and specificity exceeding 80% for all seven targeted findings. Ground truth was established by U.S. board-certified radiologists using a two-reader plus adjudicator method. The device maintained robust performance across demographics, imaging parameters, and clinical scenarios. Mean triage turnaround time was approximately 58 seconds, supporting clinical workflow integration.

Predicate Devices

No predicate devices specified

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