Intended Use

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on anatomical structures in CT and MR imaging data using machine-learning-based algorithms. It supports quantitative analysis, adaptive therapy, and radiation therapy treatment planning.

Technology

Contour ProtégéAI uses neural network machine-learning algorithms trained on a large dataset of over 4000 CT images from multiple international sites. It is deployed as a server-based application supporting Linux OS and locally on Windows or Mac. The software automatically segments multiple anatomical structures in CT and MR images to generate contours for clinical use, which must be reviewed and edited as needed with visualization software.

Performance

Performance evaluation involved non-inferiority testing comparing Contour ProtégéAI segmentation results to a reference atlas segmentation device (MIM 4.1 SEASTAR). The neural network models were trained on diverse datasets excluding test subjects. Dice coefficients showed Contour ProtégéAI was equivalent or superior in segmenting numerous anatomical structures across CT images, demonstrating safety and effectiveness comparable to predicate and reference devices.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/20/2021

    1 month
  • 2

    FDA Approval

    2/3/2022

Other devices from MIM Software Inc.

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