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Intended Use

Rapid Aneurysm Triage and Notification (ANRTN) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected saccular aneurysms during routine patient care.

Technology

The device is an AI/ML image processing software integrated within the Rapid Platform that analyzes CTA head scans in DICOM format, applying an artificial intelligence algorithm to detect suspected saccular aneurysms. It generates compressed preview images for informational use and supports study list prioritization or triage in parallel to standard care, without altering original medical images.

Performance

Performance validation included evaluation on 266 CTA cases with ground truth established by experts, achieving high accuracy with an AUC ≥ 0.95, sensitivity of 0.933 and specificity of 0.868. The device was tested across multiple scanner manufacturers, aneurysm sizes, genders, and aneurysm locations, demonstrating robust performance and conformance with relevant standards including DICOM, ISO 14971, IEC 62304, and IEC 62366.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    1/10/2023

    6 months
  • 2

    FDA Approval

    7/27/2023

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