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Intended Use

uAI Easy Triage ICH is a radiological computer-assisted triage and notification software device indicated for analysis of non-enhanced head CT images. The device assists hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected positive findings of Intracranial Hemorrhage (ICH).

Technology

The device uses artificial intelligence convolutional neural networks (CNN) and advanced image processing to analyze non-contrast head CT images and identify potential intracranial hemorrhage. It integrates with the uAI Easy Triage platform, providing active and passive notifications, including pop-up alert icons and summary information about suspected findings. It reads DICOM files, verifies protocols, runs the triage algorithm, and outputs findings in a compatible DICOM format.

Performance

The AI algorithm was trained on 9791 images from multiple sites in China and internally tested. The final validation used 295 independent US-based non-contrast head CT scans with nearly equal positive and negative ICH cases. Compared to expert neuroradiologists' readings, the software showed 92% sensitivity and 95% specificity, exceeding acceptance criteria. The average notification time was 41.1 seconds. No clinical or animal studies were required; software verification and validation testing were done.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/2/2024

    1 month
  • 2

    FDA Approval

    9/24/2024

Other devices from Shanghai United Imaging Intelligence Co., Ltd.

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