Intended Use

AATMA™ is a medical image processing library intended to produce derived data sets for use as input into radiation therapy treatment planning systems or other intermediate pre-treatment-planning applications.

Technology

The device uses machine-learning convolutional neural networks (auto-segmentation algorithms) with pre-trained models on specific datasets, functioning as a computational engine accessed via API, producing derived datasets in standard formats like DICOM without a user interface.

Performance

Performance testing included software verification, validation, and algorithmic testing on Head & Neck and Male Pelvis models trained on large clinical CT datasets. Testing showed average DICE coefficients of 0.84 and 0.93 respectively, meeting acceptance criteria. No clinical or animal testing was performed; performance was compared to a predicate device showing substantial equivalence.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    7/16/2021

    3 months
  • 2

    FDA Approval

    10/25/2021

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