Intended Use

Contour ProtégéAI is an accessory to MIM software used for the contouring of anatomical structures in imaging data using machine-learning-based algorithms automatically. It supports CT and MR modalities and requires use alongside MIM software for review and editing.

Technology

Uses machine-learning algorithms to automatically create contours on CT and MR images. Operates as a server-based application deployed on MIMcloud for data management and runs on Windows, Mac, and Linux platforms.

Performance

Performance was established through training neural networks on large multi-institutional CT and MR datasets. Testing on 286 CT and 72 MR images from independent institutions showed the device was non-inferior to predicate device contours based on Dice coefficient, meeting clinically acceptable limits.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/25/2019

    7 months
  • 2

    FDA Approval

    7/2/2020

Other devices from MIM Software Inc.

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