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Intended Use

Annalise Enterprise is designed for use in the medical care environment to aid in triage and prioritization of studies with features suggestive of vasogenic edema, analyzing non-contrast brain CT studies, and is intended for use by clinicians qualified to interpret such studies in patients 22 years or older.

Technology

The device uses an AI algorithm based on a convolutional neural network trained with deep learning techniques on a diverse dataset of non-contrast brain CT images. It interfaces with PACS/RIS systems to automatically analyze images and provide notification for prioritization if findings suggestive of vasogenic edema are identified, working alongside standard clinical workflows without downgrading case priority.

Performance

Performance testing included a retrospective, blinded study of non-contrast brain CT cases annotated by multiple neuroradiologists as ground truth. The device demonstrated high sensitivity (up to 94.9%) and specificity (up to 97.4%) in detecting vasogenic edema and effectively reduced triage turnaround time (81.6 seconds), comparable to the predicate device, supporting its safety and effectiveness for clinical use.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/16/2023

    3 months
  • 2

    FDA Approval

    9/22/2023

Other devices from Annalise-AI Pty Ltd

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