SIS Software Version 3.6.0
Surgical Information Sciences, Inc.SIS Software Version 3.6.0 is an advanced medical imaging application designed to assist neurosurgeons, neurologists, and radiologists by processing MRI and CT scans to create detailed 3D models of brain structures, particularly the subthalamic nuclei. It uses machine learning to enhance images, aiding in the visualization and planning of stereotactic brain surgeries, thereby improving surgical accuracy and patient outcomes.
Intended Use
SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including 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. It can be used as an aid in visualization of the subthalamic nuclei (STN). Typical users are medical professionals including surgeons, neurologists and radiologists.
Technology
SIS Software uses machine learning and image processing algorithms to import MRI and CT imaging sets, segment anatomical structures, perform image fusion, and generate 3D patient-specific anatomical models to aid in surgical planning. It features enhanced MR to CT registration methodologies and image processing to accommodate CT images with gantry tilt. The software enables both automated and manual tools for segmentation and fusion and supports 2D/3D visualization and intraoperative planning.
Performance
Software verification and validation testing repeated with the modified software confirmed it functions as specified and similarly to the previously cleared version. MRI to CT registration testing showed error within acceptance criteria, comparable to the predicate device. Testing of CT image processing with gantry tilt demonstrated that cropping and segmentation performance were unaffected compared to the predicate. These tests support that the software is as safe and effective as the predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/23/2019
21 days - 2
FDA Approval
9/13/2019
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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