Intended Use

Surgical Reality Viewer is a medical imaging visualization software intended to assist trained healthcare professionals with preoperative and intraoperative visualizations by displaying 2D and 3D renderings of DICOM compliant patient images and normal anatomic segmentations derived from patient images, including manipulation of segmentations and 3D models. Intended for adult patients aged 22 years and over.

Technology

Surgical Reality Viewer accepts DICOM compliant images from CT or MRI scanners and segmentation files in various 3D object file formats. It uses machine learning and computer vision algorithms to generate preliminary segmentations of normal anatomy on demand. Visualization tools include 2D and 3D image manipulation, volume and surface rendering, and immersive 3D viewing. It runs on Windows 10+ systems with specified GPU, CPU, and RAM requirements. The user interface provides tools for review, segmentation editing, annotation, and measurement.

Performance

Performance was tested on 102 CT images, with segmentations verified by trained professionals and thoracic surgeons. The AI segmentation accuracy achieved high Dice scores for various anatomical structures (e.g., lobes avg. 0.97, vessels avg. 0.84, airway avg. 0.96, aorta 0.96). Usability and clinical usefulness were validated by qualitative scoring by medical professionals with scores between 4.7 and 5.0 out of 5.

Predicate Devices

No predicate devices specified

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