SMART PCFD
Disior LtdSMART PCFD is an AI-powered software that assists orthopedic healthcare professionals in diagnosing and planning surgery for Progressive Collapsing Foot Deformity (PCFD) using weight-bearing CT images. It provides 3D models of foot and ankle anatomy, measurements, and surgical planning tools to support clinical decision-making and improve patient care.
Intended Use
SMART PCFD software includes AI-powered algorithms and is intended to be used to support orthopedic healthcare professionals in the diagnosis and surgical planning of Progressive Collapsing Foot Deformity (PCFD) in a hospital or clinic environment using weight-bearing CT (WBCT).
Technology
The software segments foot and ankle bones from CT images, creates 3D anatomical models, provides radiographic measurements and surgical planning tools for common flatfoot procedures. It's based on machine learning algorithms previously validated in a predicate device.
Performance
Software verification and validation were performed at unit, integration, and system levels; non-clinical bench testing showed surgical planning accuracy within ±1 degree for angles and ±1.0 mm for distances. Clinical data were deemed not necessary for safety and effectiveness.
Predicate Devices
No predicate devices specified
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