SIS System
Surgical Information Sciences, Inc.The SIS System by Surgical Information Sciences, Inc. is an advanced software tool that assists clinicians, including surgeons, neurologists, and radiologists, by providing detailed visualization and 3D models of specific brain structures. It uses machine learning models trained on high-resolution MR images to aid in planning and guiding deep brain stimulation surgeries and other neurological procedures, helping to precisely locate key brain areas and implanted leads for improved surgical outcomes.
Intended Use
SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including image processing, fusion, and intraoperative functional planning, used with stereotactic image guided surgery or other devices for visualizing and localizing specific brain nuclei in neurological procedures, including Deep Brain Stimulation Lead Placement.
Technology
The SIS System is software-only, employing pre-trained deep learning neural network models based on ultra-high resolution 7T MR images and clinical 1.5T and 3T MR images to generate patient-specific 3D anatomical models of brain structures. It supports visualization and localization of the subthalamic nucleus, globus pallidus, and ventral intermediate nucleus, and can also identify implanted leads in post-operative CT images.
Performance
Software testing confirmed that the SIS System functions as specified and similarly to the predicate device. Clinical validation with separate data sets showed the model visualizations of the ventral intermediate nucleus met pre-specified accuracy criteria in center of mass distance, surface distance, and Dice coefficient metrics, supporting safe and effective use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/19/2024
1 month - 2
FDA Approval
6/14/2024
Other devices from Surgical Information Sciences, Inc.
- SIS System2023 • 510K
- SIS System (Version 5.6.0)2022 • 510K
- SIS System (Version 5.1.0)2021 • 510K
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