brAIn™ Shoulder Positioning
Avatar MedicalbrAIn™ Shoulder Positioning is a cloud-based software tool that assists shoulder surgeons in planning total shoulder replacement surgeries. It automatically segments CT images of the shoulder using machine learning, allowing clinicians to visualize shoulder anatomy, position implants interactively in 3D, and receive detailed pre- and post-operative measurements and reports, facilitating more accurate and efficient surgical planning.
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 web application; uses machine learning for automatic segmentation of shoulder CT scans; interactive 3D viewer for implant positioning; generates multimodal summaries including textual pre/post-op measurements and visual screen captures.
Performance
Software verification and validation testing passed all acceptance criteria. Automatic segmentation was validated against manual segmentation achieving a Dice Similarity Coefficient ≥0.95 on a diverse dataset of 508 3D CT volumes. Shoulder side detection and measurement accuracy validations were successfully completed with no deviations. Conforms to FDA guidance and IEC 62304 standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/18/2024
5 months - 2
FDA Approval
3/20/2025
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