Automatic Registration
Brainlab AGAutomatic Registration by Brainlab AG is a software tool that facilitates image-guided surgery by automatically registering intraoperatively acquired 3D CT, CBCT, or fluoroscopic images to the surgical environment. This helps surgeons precisely correlate patient images with their anatomy during surgery, improving navigation accuracy and surgical outcomes.
Intended Use
Automatic Registration is a software device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems such as the Brainlab Spine & Trauma Navigation System. It provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images.
Technology
The device correlates intraoperatively acquired patient 3D CT/CBCT or fluoroscopic images to the surgical environment using software modules: Automatic Registration 2.6, Universal Atlas Performer 6.0, Universal Atlas Transfer Performer 6.0. It uses registration matrices, adhesive flat markers, calibration phantom and integrates workflows with 3rd party CT scanners. The new feature uses a locked AI/ML convolutional neural network for vertebra detection in 2D X-ray images to assist registration update, reducing user interaction.
Performance
Software verification and validation testing were conducted according to FDA guidance. Bench tests established system registration accuracy within ≤ 2.5 mm (95th percentile) with mean navigation accuracy ≤ 1.5 mm. AI/ML algorithm was validated for accurate vertebra detection on X-rays. Summative usability testing with 15 users showed no critical issues. No clinical testing was required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/21/2023
3 months - 2
FDA Approval
3/20/2024
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