SMART Bun-Yo-Matic CT
Disior LtdSMART Bun-Yo-Matic CT is an AI-based software tool that helps orthopedic healthcare professionals by automatically segmenting foot and ankle bones from CT images, creating 3D anatomical models, measuring structures, and providing surgical planning visualizations. This supports diagnosis and treatment planning, especially for conditions like hallux valgus, through detailed, interactive reports and templates.
Intended Use
Software to be used by orthopedic healthcare professionals for diagnosis and surgical planning using CT images of foot and ankle. Provides 3D visualization, measurements, and surgical planning related to foot and ankle orthopedic conditions.
Technology
Automatic software tool that segments foot and ankle bones from CT images, generating 3D models and case reports with measurements. Incorporates machine learning algorithms validated on diverse CT datasets. Provides surgical planning with instrument parameters and implant visualization via a GUI web application.
Performance
Performance testing demonstrated the device meets acceptance criteria for segmentation accuracy and surgical planning measurements. Tests included software verification and validation at unit, integration, and system levels, as well as non-clinical bench testing with multiple images evaluated by qualified experts. Clinical data not required to support safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/6/2024
3 months - 2
FDA Approval
6/20/2024
Other devices from Disior Ltd
- SMART Bun-Yo-Matic X-Ray2024 • 510K
- Bonelogic2023 • 510K
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