SIS System (Version 5.1.0)
Surgical Information Sciences, Inc.The SIS System (Version 5.1.0) is a medical imaging software that helps surgeons, neurologists, and radiologists visualize specific brain structures such as the subthalamic nuclei and globus pallidus from MRI and CT scans. It uses advanced deep learning models to create 3D anatomical models to aid in stereotactic surgical planning and lead placement, improving visualization and accuracy during procedures.
Intended Use
SIS System is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing and visualization. The device can be used in conjunction with other clinical methods as an aid in visualization of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively).
Technology
The SIS System uses pretrained deep learning neural network models based on ultra-high resolution 7T MRI datasets to predict patient-specific 3D brain structures from clinical MRI scans. It incorporates updated deep learning convolutional neural network models optimized for brain image segmentation. It also segments implanted leads from postoperative CT images and determines their orientation relative to segmented brain structures.
Performance
The device underwent verification and validation testing including visualization accuracy testing for target brain regions, MRI to CT registration accuracy, lead segmentation, and electrode orientation detection accuracy. Orientation detection was correct in 91% of trusted cases within ±30° accuracy, demonstrating performance comparable to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/11/2021
2 months - 2
FDA Approval
3/31/2021
Other devices from Surgical Information Sciences, Inc.
- SIS System2024 • 510K
- SIS System2023 • 510K
- SIS System (Version 5.6.0)2022 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.