Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Brainlab AGThe Cranial Navigation and Cranial EM System by Brainlab AG is an image-guided surgical navigation system designed to assist surgeons during cranial and craniofacial procedures. It uses imaging data like CT, MR, X-Ray, and ultrasound to track surgical instruments relative to patient anatomy. The system integrates artificial intelligence via machine learning algorithms to detect brain abnormalities and anatomical landmarks in MR images to enhance registration accuracy and view centering, helping surgeons perform more precise navigation in complex brain surgeries.
Intended Use
Image-guided planning and navigation system to enable navigated cranial surgery and neurosurgical procedures using multiple imaging modalities (CT, CTA, X-Ray, MR, MRA, ultrasound).
Technology
The device uses optical and electromagnetic tracking technologies integrated within an Image Guided Surgery (IGS) platform (Curve, Kick, Buzz Navigation). The AI/ML algorithm is a convolutional neural network trained for detection of brain abnormalities and anatomical landmarks in T1-weighted contrast-enhanced MR images to support registration and improve visualization. This is a locked, static algorithm integrated within the software modules for registration and navigation.
Performance
The device underwent software verification and validation consistent with FDA guidance for software in medical devices. AI/ML-based features were performance tested comparing conventional atlas-based detection versus machine learning detection, showing equivalent or better performance. Usability evaluation was performed simulating clinical environment. Accuracy testing showed a mean positional error ≤ 2 mm and mean angular error ≤ 2°, meeting acceptance criteria. Electrical safety, EMC, and biocompatibility testing of instruments were also conducted. No clinical testing was needed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/25/2022
8 months - 2
FDA Approval
7/21/2023
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