SIS Software version 3.3.0
Surgical Information Sciences, Inc.SIS Software version 3.3.0 is a medical imaging application that assists clinicians, including surgeons and neurologists, by enhancing and visualizing brain MRI images, specifically the subthalamic nucleus (STN). It uses AI and image processing techniques to create 3D models and supports image fusion and co-registration between MRI and CT scans to guide stereotactic surgical procedures more accurately.
Intended Use
SIS Software is intended for use in viewing, presentation, and documentation of medical imaging, including image processing, image fusion, and intraoperative functional planning where 3D output aids stereotactic image guided surgery. It helps visualize the subthalamic nuclei as an aid in clinical procedures.
Technology
The software uses machine learning and image processing to enhance clinical MRI images by referencing a high-resolution 7T MRI database. It generates patient-specific 3D models of brain structures and supports co-registration of postoperative CT scans with preoperative MRI, segmenting CT electrodes to assist in visualization and surgical planning.
Performance
Validation testing demonstrated accurate visualization of STN with center of mass errors mostly under 2 mm, registration accuracy under 0.5 mm, and segmentation of electrodes in CT scans within 1 mm and 5 degrees orientation difference. Anomaly detection in the software improved sensitivity while maintaining specificity, supporting safe and effective surgical planning.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/31/2018
4 months - 2
FDA Approval
3/19/2019
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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