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Intended Use

Annalise Enterprise is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of obstructive hydrocephalus in non-contrast brain CT studies. It provides study-level output to imaging and order management systems for worklist prioritization or triage, is intended for use by trained clinicians qualified to interpret brain CT studies, and is for patients aged 22 years or older. It is not intended for standalone clinical decision making or to preclude clinical assessment.

Technology

The device uses an AI algorithm based on a convolutional neural network trained on over 200,000 annotated CT brain images from various manufacturers using deep learning. It processes non-contrast brain CT studies obtained via PACS/RIS, identifies suspected obstructive hydrocephalus findings, and communicates prioritization notifications to imaging and order management systems. It operates in parallel with standard clinical workflows without downgrading existing study priorities.

Performance

Performance was assessed in a retrospective, independent dataset test including 175-191 cases from US hospital sites, with representation across demographics and scanner types. The AI showed high sensitivity (up to 97.6%) and specificity (up to 97.0%) for obstructive hydrocephalus detection. Triage turn-around time was comparable to the predicate device (~81.6 seconds). The device was shown to be safe, effective, and substantially equivalent to the predicate device.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    4/18/2023

    3 months
  • 2

    FDA Approval

    8/15/2023

Other devices from Annalise-AI Pty Ltd

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