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.

Technology

Contour ProtégéAI+ uses machine-learning algorithms for creating anatomical contours on medical CT and MR images. It operates on multiple computer systems (Windows, Mac, Linux) and can be deployed locally or on a cloud-based remote server (MIMcloud).

Performance

The device was tested on 770 images from 32 institutions, showing equivalent or superior performance to predicate atlas segmentation software based on Dice scores and mean distance agreement (MDA). User evaluations demonstrated clinically meaningful time savings. Cumulative Added Path Length (APL), a surrogate for editing time, was significantly lower than predicate devices. Testing included extensive neural network models, with validations for multiple anatomical structures and multiple CT models.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    1/7/2025

    27 days
  • 2

    FDA Approval

    2/3/2025

Other devices from MIM Software Inc.

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