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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 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.

The provided text is a 510(k) summary for the SIS System, which is a modification of a previously cleared device. The summary states that "the software verification and validation testing was conducted to validate that the software functions as specified and performs similarly to the predicate device using the same acceptance criteria and the same test designs as used for the previously cleared predicate device." However, the document does not provide the specific acceptance criteria, the detailed results of the performance testing against these criteria, or the methodology of the studies (e.g., sample size, data provenance, ground truth establishment, expert qualifications, etc.) for either the original predicate device or the modified device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about the studies (sample sizes, ground truth establishment, expert qualifications, MRMC studies, etc.) as the information is not present in the provided document. The document only confirms that such testing was performed and that the results demonstrated substantial equivalence to the predicate.

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