SpineAR SNAP (SyncAR Spine)
Surgical Theater, Inc.SpineAR SNAP is a software-based augmented reality system designed to assist surgeons in pre-operative and intra-operative spinal stereotaxic surgery planning and guidance. It uses AI/ML-powered vertebra segmentation to enhance surgical planning for procedures like pedicle screw placement, visualizing 3D models on a desktop or through an AR headset, improving accuracy and surgical workflow.
Intended Use
SpineAR SNAP is intended for use for pre-operative surgical planning on-screen and in a virtual environment, and intra-operative surgical planning and visualization on-screen and in an augmented environment using the HoloLens2 AR headset display with validated navigation systems. Indicated for spinal stereotaxic surgery and spinal implant procedures such as Pedicle Screw Placement in lumbar and thoracic regions.
Technology
Software-based device running on a high-performance desktop PC, transforming 2D medical images into an interactive 3D scene for surgical planning. Interfaces with 3rd party navigation systems (e.g., Medtronic StealthStation S8) and projects live navigation data and guidance into an AR headset (Microsoft HoloLens2). Incorporates AI/ML vertebra segmentation to optimize surgical planning workflow by segmenting vertebrae with a 3D U-Net neural network model trained on diverse CT and MRI datasets.
Performance
Performance validation conducted on CT and MRI datasets demonstrated high segmentation accuracy, surpassing the acceptance criteria with mean Dice Coefficients above 0.8 for vertebrae and sacrum. The segmentation algorithm was trained and validated on diverse multi-center datasets to ensure robustness across different patient demographics and scanner types. Non-clinical testing including human factors, cybersecurity, and software verification confirmed device safety and effectiveness.
Predicate Devices
No predicate devices specified
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