SIS System (Version 5.6.0)
Surgical Information Sciences, Inc.The SIS System version 5.6.0 is a medical imaging software that helps surgeons, neurologists, and radiologists visualize specific brain structures in 3D to assist with planning neurological surgeries such as deep brain stimulation. It uses advanced image processing and machine learning techniques to create patient-specific anatomical models from MRI and CT images, improving precision during surgical interventions.
Intended Use
SIS System is 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, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement. Typical users of the SIS Software are medical professionals, including but not limited to surgeons, neurologists and radiologists.
Technology
The SIS System version 5.6.0 is a software-only device based on machine learning and image processing. It enhances standard clinical MRI images for visualization of basal ganglia structures of the brain using pre-trained deep learning neural networks trained with ultra-high resolution 7 Tesla MR images as ground truth. The software provides patient-specific 3D anatomical models of the subthalamic nucleus and globus pallidus from patient MRI scans, segments implanted leads visible in post-operative CT images, and spatially relates these to the brain structures. It updates minor backend software elements but retains the core algorithm from prior versions.
Performance
The software underwent repeated software verification and validation testing to confirm it functions as intended and performs comparably to the previously cleared version 5.1.0. Testing covered visualization accuracy of target brain structures, MRI to CT registration accuracy, postoperative CT image lead segmentation, and electrode orientation detection. Results demonstrated that version 5.6.0 is as safe and effective as the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/29/2022
1 month - 2
FDA Approval
11/21/2022
Other devices from Surgical Information Sciences, Inc.
- SIS System2024 • 510K
- SIS System2023 • 510K
- SIS System (Version 5.1.0)2021 • 510K
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