SMART Bun-Yo-Matic X-Ray
Disior LtdSMART Bun-Yo-Matic X-Ray is a software tool that uses X-ray images of the foot and ankle to create 3D mathematical models, provide radiographic measurements, and assist orthopedic healthcare professionals in diagnosis and surgical planning. The software visualizes patient anatomy and orthopedic fixation devices, enabling precise pre-surgical planning to improve treatment outcomes for foot and ankle conditions such as hallux valgus.
Intended Use
Software for diagnosis and surgical planning of foot and ankle orthopedic conditions using X-ray imaging input.
Technology
Uses machine learning algorithms to generate 3D axes and mathematical models of foot and ankle anatomy and orthopedic fixation devices from weight-bearing X-ray images, producing automated case reports for surgical planning.
Performance
Performance testing included software verification, accuracy assessment against ground truth from expert clinicians, and validation on diverse X-ray and CBCT DRR datasets. Results met acceptance criteria of 95% model conformance within 1.0mm and angular accuracy ±1 degree, showing the device performs as intended without safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/18/2024
3 months - 2
FDA Approval
7/2/2024
Other devices from Disior Ltd
- SMART Bun-Yo-Matic CT2024 • 510K
- Bonelogic2023 • 510K
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