ENT EM
Brainlab AGENT EM is a surgical navigation system designed to assist surgeons during ear, nose, and throat procedures by providing real-time guidance using electromagnetic tracking. It integrates with patient imaging data from multiple modalities to accurately localize instruments and anatomical structures, improving surgical precision and safety. The device includes an AI/ML-based algorithm to aid in the registration step by automatically detecting anatomical landmarks, streamlining the planning and navigation process.
Intended Use
ENT EM is intended as an image-guided planning and navigation system to enable ENT procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as intranasal structures and paranasal sinus surgery including functional endoscopic sinus surgery (FESS) and anterior skull base procedures.
Technology
ENT EM uses electromagnetic tracking technology combined with image-guided surgery platforms and surgical instruments. It employs software modules for registration, instrument calibration, patient referencing, and navigation. It introduces an AI/ML convolutional neural network algorithm to aid the registration step by providing automatic detection of anatomical landmarks to support pre-registration based on guide points. The system continuously localizes instruments relative to patient imaging data for navigation during ENT surgeries.
Performance
Performance testing included software verification and validation, including AI-based landmark detection showing equivalent performance compared to conventional methods. System accuracy evaluation demonstrated mean positional error ≤2 mm and mean angular error ≤2°, meeting acceptance criteria. Usability testing in simulated clinical environments confirmed safety and effectiveness. Electrical safety and EMC tests confirmed compliance. Biocompatibility and reprocessing validation were provided for instruments. No clinical testing was needed due to established technology. Bench testing confirmed substantial equivalence with predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/13/2022
4 months - 2
FDA Approval
4/27/2023
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