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SIS System is intended for use in the viewing, presentation 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. The device can be used in conjunction with other clinical methods as an aid in visualization of the subthalamic nuclei (STN), globus pallidus externa and interna (GPe and GPi, respectively) and the ventral intermediate nucleus (Vim) 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.

The SIS System is a software only device based on machine learning and image processing. The device is designed to enhance standard clinical images for the visualization of structures in the basal ganglia and thalamus areas of the brain, specifically the subthalamic nucleus (STN), globus pallidus externa and interna (GPe/GPi), and ventral intermediate nucleus (Vim). The output of the SIS system supplements the information available through standard clinical methods by providing additional, adjunctive information to surgeons, neurologists, and radiologists for use in viewing brain structures for planning stereotactic surgical procedures and planning of lead output. The SIS System provides a patient-specific, 3D anatomical model of specific brain structures based on the patient's own clinical MR image using pre-trained deep learning neural network models. The model training method incorporates ultra-high resolution 7T (7 Tesla) Magnetic Resonance (MR) images to determine ground truth for the training dataset, which is comprised of clinical (1.5T and 3T) MR imaqes. These pre-trained deep learning neural network models are then applied to a patient's clinical image to predict the shape and position of the patient's specific brain structures of interest. SIS System is further able to locate and identify implanted leads, where implanted, visible in post-operative CT images and place them in relation to the brain structure of interest from the preoperative processing. The proposed device is a modification to the SIS System version 6.0.0 that was cleared under K230977. The primary change is the addition of new brain structures to prediction - Vim is now supported based on pre-trained deep learning neural network models.

SIS System is intended for use in the viewing, presentation 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 processing, visualization and localization. The device can be used in coniunction with other cinical methods as an aid in visualization 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.

The SIS System is a software only device based on machine learning and image processing. The device is designed to enhance standard clinical images for the visualization of structures in the basal gandlia area of the brain, specifically the subthalamic nucleus (STN) and globus pallidus externa and interna (GPe/GPi). The output of the SIS system supplements the information available through standard clinical methods by providing additional, adjunctive information to surgeons, neurologists, and radiologists for use in viewing brain structures for planning stereotactic surqical procedures and planning of lead output. The SIS System provides a patient-specific, 3D anatomical model of specific brain structures based on the patient's own clinical MR image using pre-trained deep learning neural network models. As discussed in more detail below, the method incorporates ultra-high resolution 7T (7 Tesla) Maqnetic Resonance images to determine ground truth for the training data set to train the deep learning models. These pre-trained deep learning neural network models are then applied to a patient's clinical image to predict the shape and position of the patient's specific brain structures of interest. SIS System is further able to locate and identify implanted leads, where implanted, visible in post-operative CT images and place them in relation to the brain structure of interest from the preoperative processing. The proposed device is a modification to the SIS System version 5.6.0 that was cleared under K223032. The primary changes are the addition of two compatible leads, minor modification to image registration algorithm, and a feature to allow users to view post-operative 3D model in a different coordinate system.

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.

The SIS System version 5.6.0 is a software only device based on machine learning and image processing. The device is designed to enhance standard clinical images for the visualization of structures in the basal ganglia area of the brain, specifically the subthalamic nucleus (STN) and globus pallidus externa and interna (GPe/GPi). The output of the SIS system supplements the information available through standard clinical methods by providing additional, adjunctive information to surgeons, neurologists, and radiologists for use in viewing brain structures for planning stereotactic surqical procedures and planning of lead output. The SIS System version 5.6.0 provides a patient-specific, 3D anatomical model of specific brain structures based on the patient's own clinical MR image using pre-trained deep learning neural network models. As discussed in more detail below, the method incorporates ultra-high resolution 7T (7 Tesla) Magnetic Resonance images to determine ground truth for the training data set to train the deep learning models. These pre-trained deep learning neural network models are then applied to a patient's clinical image to predict the shape and position of the patient's specific brain structures of interest. SIS System is further able to locate and identify implanted leads, where implanted, visible in post-operative CT images and place them in relation to the brain structure of interest from the preoperative processing. The proposed device is a modification to the SIS System version 5.1.0 that was cleared under K210071. The primary change is an update to the indications for use statement to clarify that deep brain stimulation (DBS) lead placement is a type of procedure that may be assisted by the information generated by the SIS System. The technological characteristics of the proposed device are fundamentally the same with minor updates to the backend of the software. The core algorithm that processes patient images has not changed since the prior clearance.

SIS System is an application intended for use in the viewing, presentation 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 quided surgery or other 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).

The SIS System version 5.1.0, a software only device based on machine learning and image processing, is designed to enhance standard clinical images for the visualization of structures in the basal ganglia area of the brain, specifically the subthalamic nucleus (STN) and globus pallidus externa and interna (GPe/GPi). The output of the SIS system supplements the information available through standard clinical methods by providing additional, adjunctive information to surgeons, neurologists, and radiologists for use in viewing brain structures for planning stereotactic surgical procedures and planning of lead output. The SIS System version 5.1.0 provides a patient-specific, 3D anatomical model of specific brain structures based on the patient's own clinical MR image using pretrained deep learning neural network models. This method incorporates ultra-high resolution 7T (7 Tesla) Magnetic Resonance images to determine ground truth for the training data set to train the deep learning models. These pre-trained deep learning neural network models are then applied to a patient's clinical image to predict the shape and position of the patient's specific brain structures of interest. The SIS System is further able to locate and identify implanted leads, where implanted, visible in post-operative CT images and place them in relation to the brain structure of interest from the preoperative processing. The proposed device is a modification to the SIS Software version 3.6.0 that was cleared under K192304. The changes made to the SIS System include (1) an updated algorithm that is based on deep learning Convolutional Neural Network models that were architected and optimized for brain image segmentation; (2) the addition of new targets for visualization, specifically the globus pallidus externa and interna (GPe/GPi); and (3) the addition of a functionality to determine the orientation of a directional lead, following its segmentation from the post-operative CT image.

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 conjunction 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 adjunctive information 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 neurosurgical procedures. The version of the software that is the subject of the current submission (Version 3.6.0) is a modification to the predicate SIS Software version 3.3.0 that was cleared under K183019. The subject and predicate devices rely on the same core technological principles. The only minor changes were modifications to enable the use of a more comprehensive MR to post operation CT registration methodology, and image processing techniques for CT images acquired with gantry tilt. The web user interface has also been enhanced to allow additional options for administrators/supervisors, and has added audit logging functions.

SIS Software is an application intended for use in the viewing, presentation 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 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 conjunction 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 adjunctive information 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 neurosurgical procedures. The version of the software that is the subject of the current submission (Version 3.3.0) can also be employed to co-register a post-operative CT scan with the clinical scan of the same patient from before a surgery (on which the software has already visualized the STN) and to segment in the CT image (where needed), to further assist with visualization.

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.