Intended Use

Contour ProtégéAI is an accessory to MIM software. It includes processing components to automatically contour imaging data using machine-learning based algorithms.

Technology

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through machine-learning algorithms. It operates on Windows, Mac, and Linux systems, deployable on remote servers or locally, and uses trained neural network models based on a large multi-institutional dataset of CT images.

Performance

Performance testing includes non-inferiority comparison against a predicate device using Dice scores, MDA scores, and user beta testing for time savings. Validation was performed on a disjoint set of 754 images from 27 institutions covering diverse patient demographics and scanner manufacturers. Results showed equivalence or better performance than the predicate device across multiple anatomical structures and models. Localization accuracy and cumulative added path length (APL) were also assessed, supporting safety and effectiveness.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/16/2023

    4 months
  • 2

    FDA Approval

    11/8/2023

Other devices from MIM Software Inc.

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