Brainlab Elements � Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
Brainlab AGBrainlab Elements Trajectory Planning (2.6) is a software designed to help neurosurgeons plan the best paths for surgical instruments during cranial procedures, such as electrode placements or biopsies. It uses anatomical images from scans to plan and guide minimally invasive or open surgeries, enhancing precision and improving patient outcomes.
Intended Use
Brainlab Elements Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures. It is indicated for any medical condition in which stereotactic surgery may be appropriate for instrument placement.
Technology
The software plans minimally invasive pathways for surgical instruments using processing and viewing of anatomical images and corresponding planning data (co-registrations, segmentations, fiber tracts). It creates measurements and coordinates used as input for surgical intervention and supports multiple planning roles such as trajectory creation, stereotaxy, and lead localization.
Performance
Verification included software integration and unit testing, impact analysis for changes, and verification of SOUP and cybersecurity. Bench testing validated the accuracy and robustness of automatic and semi-automatic bone anchor detection on CT data compared to predicate software. Summative usability evaluation confirmed new workflow features for stereotactic platform planning and GUI improvements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2022
4 months - 2
FDA Approval
4/19/2023
Other devices from Brainlab AG
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