brAIn Shoulder Positioning
Avatar MedicalbrAIn™ Shoulder Positioning is a cloud-based software tool designed to assist shoulder surgeons in preoperative planning and visualization for total shoulder replacement surgeries. It uses AI to automatically segment shoulder CT scans and provides an interactive 3D interface to position implants and review anatomical changes, helping surgeons plan surgeries with detailed measurements and visualizations.
Intended Use
brAIn™ Shoulder Positioning is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.
Technology
Cloud-based application that processes DICOM shoulder CT scans, performs automatic machine learning-based segmentation of scapula and humerus, provides manual implant positioning within an interactive 3D viewer including soft tissue visualization, and outputs planning reports with measurements and images.
Performance
The device underwent comprehensive nonclinical software verification and validation testing, including segmentation accuracy validated with a mean Dice Similarity Coefficient ≥ 0.95, shoulder side detection validation against clinical specialist review, landmark measurement accuracy within 1 degree or mm criteria, and stability testing for multiple simultaneous users. Testing confirmed the software meets performance and safety specifications and demonstrates equivalence to the predicate device.
Predicate Devices
No predicate devices specified
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