Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

Brainlab Elements 7.0 is a suite of medical image processing software applications for surgical and radiotherapy treatment planning. It includes Image Fusion (rigid and deformable image registration), Image Fusion Angio (cerebrovascular image co-registration), Contouring (anatomical structure segmentation with AI-assisted tumor detection), Fibertracking (white matter tract visualization), and BOLD MRI Mapping (functional activation analysis). The software is not intended for diagnostic purposes and supports cranial and extracranial surgical planning and radiotherapy treatment planning.

The subject device maintains core functionality of the predicate (Image Fusion 4.5, Contouring 4.5, Fibertracking 2.0, Image Fusion Angio 1.0, BOLD MRI Mapping 1.0) with enhancements including: support for ultrasound in virtual iMRI calculations, automatic tumor segmentation using machine learning, probabilistic tracking algorithms (CSD) alongside deterministic tracking, blending mode for multi-modal visualization, automatic resection cavity segmentation, and expanded operating system support (Windows Server 2022). Hardware requirements increased to support advanced features (e.g., GPU requirements for AI tumor segmentation).

Not stated in this summary.

Brainlab Elements 7.0 is substantially equivalent because it maintains the same indications for use, intended user profiles, and clinical applications as the predicate device (K223106). Although new features were added (AI tumor segmentation, probabilistic tracking, ultrasound support), these represent enhancements to existing functional categories rather than fundamentally new intended uses. The device operates on the same DICOM image data, uses the same registration and visualization methodologies, and is deployed in identical clinical environments (hospital surgical and radiotherapy planning rooms). Performance validation confirmed that new features (e.g., AI tumor segmentation with Dice ≥0.7, CSD tracking algorithms) function as intended and do not introduce new risks or change the device's role in treatment planning workflows.