(130 days)
SIS Software is an application intended for use in the viewing, presentation of medical imaging, including different modules for image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image quided 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).
SIS Software 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 coniunction with other clinical methods as an aid in visualization of the subthalamic nuclei (STN).
SIS Software uses machine learning and image processing to enhance standard clinical images for the visualization of the subthalamic nucleus ("STN"). The SIS Software supplements the information available through standard clinical methods, providing additional, adjunctive information to surgeons, neurologists and radiologists for use in visualization and planning stereotactic surgical procedures. SIS Software provides a patient specific, 3D anatomical model of the patient's own brain structures that supplements other clinical information to facilitate visualization in neurosurqical procedures. The software makes use of the fact that some structures in the brain are not easily visualized in 1.5T or 3T clinical MRJ, but are better visualized using high-resolution and high-contrast 7T MRI.
The company's software methodology relies on a reference database of high-resolution brain images (7T MRI) and standard clinical brain images (1.5T or 3T MRI). The 7T images allow visualization of anatomical structures that are then used to find regions of interest within the brain (i.e., the STN) on a patient's clinical image.
SIS visualization is incorporated in the standard clinical MR data, thereby not changing the current standard-of-care workflow protocol and does not require any additional visualization software or hardware platforms.
Here's a breakdown of the acceptance criteria and the study that proves the SIS Software meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are focused on the accuracy of the Subthalamic Nuclei (STN) visualization. The study compared the machine-predicted STN to ground truth STN.
| Acceptance Criteria (Pre-specified) | Reported Device Performance |
|---|---|
| 90% of Center of Mass Distances not greater than 2.0mm | 95% of Center of Mass Distances were not greater than 2.0mm (95% CI: 86.91 - 98.37%) |
| 90% of Surface Distances not greater than 2.0mm | 100% of Surface Distances were not greater than 2.0mm (95% CI: 94.25 - 100%) |
| Significance vs. Standard of Care (20% successful visualizations) | The rate of successful visualizations from SIS Software (95% of center of mass distances not greater than 2.0mm) is significantly greater than the standard of care (p |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).