Intended Use

Accessory to MIM software to automatically contour anatomical structures in CT and MR images using machine-learning algorithms, supporting tasks like adaptive therapy, radiation therapy planning, and follow-up management. Results must be reviewed and edited if necessary.

Technology

Software accessory to MIM software that employs machine-learning neural network models to automatically generate contours on medical images. Supports server-based, cloud, and local deployment on Windows, Mac, and Linux platforms.

Performance

Trained with a diverse dataset of 326 CT images from 37 clinical sites worldwide, the software's neural network models were evaluated on 819 independent images across 10 institutions. The performance was measured using the Dice coefficient and showed equivalence or superiority compared to predicate atlas-based segmentation software. Preliminary user evaluation showed comparable time-saving efficiency.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/16/2022

    3 months
  • 2

    FDA Approval

    4/6/2023

Other devices from MIM Software Inc.

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