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Intended Use

OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. It processes pre-operative DICOM compatible MR images to generate 3D annotated brain models to aid neurosurgical functional planning and localization of Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM).

Technology

OptimMRI processes brain MR images from commercially available devices in DICOM format, enabling qualified professionals to display, analyze, annotate, and interpret them. It provides 2D and 3D visualization, semi-automatic segmentation using machine learning models for anatomical annotation, and exports outputs compatible with surgical planning systems.

Performance

Performance evaluation compared segmentations produced by OptimMRI against predicate and reference devices on retrospective brain MRI data. The study showed at least 90% of surface distances for STN or VIM segmentations were within 2.0mm of reference, matching performance of predicate device SIS software. No new safety or efficacy issues were identified, supporting substantial equivalence.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    1/19/2023

    6 months
  • 2

    FDA Approval

    7/21/2023

Other devices from RebrAIn, SAS

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