Bonelogic
Disior LtdBonelogic is a software used by orthopedic healthcare professionals to assist in diagnosis and surgical planning of foot and ankle conditions using CT scan data. It provides semi-automatic segmentation of bones, creates 3D models, and offers measurement tools to support clinical decision-making and treatment planning.
Intended Use
Bonelogic software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. It provides semi-automatic segmentation from CT imaging input, 3D anatomical models of foot and ankle bones, measurement templates, and surgical planning tools.
Technology
Software segments bone anatomy from CT images using semi-automatic tools with optional assisted input via a locked artificial neural network (ANN) model, generating 3D patient-specific bone models for visualization and surgical planning.
Performance
Performance testing included software verification and validation at unit, integration, and system levels, showing 95% model conformance within 1.0 mm and 2.0 degrees for angular measurements. Clinical testing on 82 CT image series showed 100% correct bone identification and 98.8% correct metal detection sensitivity and specificity. Testing datasets included diverse patients and multiple imaging system manufacturers.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/15/2022
11 months - 2
FDA Approval
12/8/2023
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