VEA Align; spineEOS
EOS imagingVEA Align and spineEOS are cloud-based medical imaging software products by EOS imaging designed to assist healthcare professionals. VEA Align helps assess spinal and lower limb alignment using 2D X-rays with AI-generated anatomical landmarks for precise angle and length measurements. spineEOS facilitates preoperative planning for spine surgeries with access to 3D spine datasets and clinical measurements, enabling tailored surgical strategies. Both tools support clinicians by improving diagnostic accuracy and surgical planning through advanced image analysis and AI.
Intended Use
VEA Align assists healthcare professionals with global alignment assessment through clinical parameters computation using biplanar 2D X-ray images acquired with EOS imaging systems. spineEOS assists healthcare professionals with preoperative planning of spine surgeries using EOS images and associated 3D datasets.
Technology
Cloud-based software using biplanar 2D X-ray images and associated 3D datasets generated exclusively by EOS imaging systems. Implements a machine learning-based algorithm for initial placement of anatomical landmarks with user adjustments. spineEOS includes surgical planning tools to define patient-specific strategies. Software operates on cloud infrastructure with user access management.
Performance
Verification and validation testing showed the AI algorithm accurately places skeletal landmarks, reconstructs 3D spine models, and meets acceptance criteria (median error ≤ 3mm, 3rd quartile ≤ 5mm). Tested on over 538 patients across diverse subgroups, demonstrating generalizability and substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/1/2024
3 months - 2
FDA Approval
6/25/2024
Other devices from EOS imaging
- VEA Align2024 • 510K
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