RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
Brainlab AGRT Elements 4.5 is a computer-based software suite designed to assist clinicians in planning radiation treatments for brain, spine, and extracranial lesions. It supports stereotactic and conformal radiation therapy by providing optimized treatment plans, dose reviews, and AI-based tumor segmentation, helping improve accuracy and efficiency in patient treatment.
Intended Use
The device is intended for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment and indicated for cranial, head and neck and extracranial lesions.
Technology
Software platform with multiple modules supporting radiation treatment planning using co-registered DICOM image sets from CT, MRI, PET. Includes AI/ML powered tumor segmentation trained on MRI data and dose optimization algorithms (Pencil Beam and Monte Carlo). Outputs DICOM RT dose plans for linear accelerator radiation therapy delivery.
Performance
The device underwent extensive performance testing including software verification, optimization algorithm comparison, dose calculation validation for accuracy with phantom measurements, validation of reference beam models, small field dose calculation, and AI tumor segmentation accuracy. The AI segmentation was validated on 595 scans from 412 patients across multiple clinical sites, showing good Dice scores (≥0.7) with high precision and recall for cranial tumors including metastases and meningiomas.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/14/2025
4 months - 2
FDA Approval
6/17/2025
Other devices from Brainlab AG
- 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)2025 • 510K
- TraumaCad Neo (1.1)2025 • 510K
- Mixed Reality Spine Navigation2025 • 510K
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