Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
Brainlab AGAlignment System Cranial by Brainlab AG is a surgical navigation system designed to assist surgeons during cranial stereotactic procedures such as biopsies of intracranial lesions and placement of stereo-electroencephalography electrodes. It integrates optical tracking with advanced software and hardware to precisely guide surgical instruments, improving accuracy and safety. The system includes artificial intelligence features that aid in patient registration processes by detecting anatomical landmarks, enhancing surgical planning and execution.
Intended Use
Intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures, including biopsy of intracranial lesions and placement of SEEG electrodes.
Technology
A combined hardware and software system using optical tracking cameras to track surgical instruments relative to patient anatomy on pre- or intraoperative images. The system uses AI/ML with a convolutional neural network to support a pre-registration step by providing guide points based on anatomical landmarks, improving registration accuracy. The system supports positioning devices that are either robotic or manual with articulated arms for instrument guidance.
Performance
Software verification and validation were performed with FDA recommended guidance, showing equivalent performance of AI/ML landmark detection compared to conventional methods. Usability studies demonstrated safe and effective use in clinical relevant workflows. System accuracy testing showed mean positional error ≤ 2mm and mean angular error ≤ 2°, meeting acceptance criteria. Additional testing confirmed electrical safety, EMC compliance, and mechanical durability of instruments. No new clinical testing was conducted as the optical tracking tech is well established.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/23/2022
8 months - 2
FDA Approval
9/9/2023
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