X-Guide Surgical Navigation System
X-Nav Technologies, LLCThe X-Guide Surgical Navigation System is an advanced computer-assisted navigation tool designed to assist dental surgeons during preoperative planning and intraoperative guidance of dental implants and endodontic access procedures. It integrates machine learning software to automatically process CT and intraoral scan images to segment anatomical structures and enhance surgical precision, improving patient safety and surgical outcomes.
Intended Use
The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures for partially edentulous and edentulous adult and geriatric patients.
Technology
The system integrates machine learning software trained on varied CT and intraoral scan data to automatically segment anatomical features (teeth, maxilla, mandible, sinuses, nerve canals) and assist with surgical planning including pan curve creation, IOS to CT registration, and surface generation, overlaid on original CT images without altering them. It uses stereo cameras and video tracking for accurate real-time tracking of surgical instruments relative to patient anatomy.
Performance
No clinical studies were performed for this submission. Software verification and validation testing demonstrated that the machine learning outputs correct anatomical segmentations and the integrated software meets specified requirements. Risk analysis per ISO 14971:2019 was conducted, and IEC 62304 software development standards were followed. The device compliance includes adherence to ASTM F2554-18 for positional accuracy of computer-assisted surgical systems.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/19/2023
7 months - 2
FDA Approval
2/21/2024
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