SIS Software
Surgical Information Sciences, Inc.SIS Software is designed to help medical professionals such as surgeons, neurologists, and radiologists visualize and plan surgeries targeting brain structures, particularly the subthalamic nucleus. It uses machine learning and image processing to enhance standard MRI images and create patient-specific 3D models of brain anatomy, supporting safer and more precise stereotactic surgical procedures.
Intended Use
SIS Software is intended for viewing, presentation, and documentation of medical imaging with modules for image processing, image fusion, and intraoperative functional planning to aid in visualization of the subthalamic nuclei as an adjunct to stereotactic surgical procedures.
Technology
The software uses machine learning and a reference database combining high-resolution 7T MRI and standard clinical MRI (1.5T or 3T) images to create enhanced 3D models of brain structures that are difficult to visualize on routine MRI, facilitating neurosurgical planning without requiring changes to standard imaging protocols.
Performance
Performance testing included developmental and pivotal validation using retrospective and separate clinical datasets. The software's predictions of the subthalamic nucleus location were within an average of 1mm from the gold-standard 7T MRI segmentations, with 90-95% of measurements under 2mm, demonstrating performance significantly better than standard care and meeting all pre-specified criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/7/2016
4 months - 2
FDA Approval
2/14/2017
Other devices from Surgical Information Sciences, Inc.
- SIS System2024 • 510K
- SIS System2023 • 510K
- SIS System (Version 5.6.0)2022 • 510K
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