Bonelogic

Disior Ltd
Bonelogic Model Card
Product Details
Model Identifier
Manufacturer
Disior Ltd
Product
Bonelogic
Version
Unknown
Date Cleared
12/08/2023
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
CT Image of foot and ankle
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
Bonelogic software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. Bonelogic software provides: • Semi-automatic segmentation with manual or assisted input of bony structure identification from CT imaging input, • Three-dimensional mathematical models of the anatomical structures of foot and ankle, • Measurement templates containing radiographic measures of foot and ankle, and tools for manually obtaining linear and angular measurements, • Surgical planning application for foot and ankle using three-dimensional models of the anatomical structures and radiographic measures. The three-dimensional models of the anatomical structures combined with the measurements can be used for the diagnosis of orthopaedic healthcare conditions. The surgical planning application containing the three-dimensional structural models combined with the measurements can be used for the planning of treatments and operations to correct orthopaedic healthcare conditions of foot and ankle.
Intended User
Orthopedic healthcare professionals
Age
Unknown
Anatomy
Lower Extremity
Modality
CT
Output
• Semi-automatic segmentation with manual or assisted input of bony structure identification from CT imaging input, • Three-dimensional mathematical models of the anatomical structures of foot and ankle, • Measurement templates containing radiographic measures of foot and ankle, and tools for manually obtaining linear and angular measurements, • Surgical planning application for foot and ankle using three-dimensional models of the anatomical structures and radiographic measures. The three-dimensional
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unknown
Age Range (Years)
Unknown
Sex (%)
  • Female: Unknown
  • Male: Unknown
  • Unknown: Unknown
Output
Unknown
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
  • USA: Unknown
  • International: Unknown
  • Unknown: Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
Model Performance
Study Type
Performance Testing Type
Stand-Alone Performance
Standalone Model Performance
Reference Standard (Ground Truth)
Interpretation by Reviewing Clinician
No. of Cases
275
Age Range (Years)
Unknown
Sex (%)
  • Female: Unknown
  • Male: Unknown
  • Unknown: Unknown
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
USA: 50
International: 50
Output
Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
Reader Study Performance
No. of Readers
N/A
No. of Cases
N/A
No. of Sites
N/A
Output
N/A
Age Range (Years)
N/A
Sex (%)
  • Female: N/A
  • Male: N/A
  • Unknown: N/A
Race (%)
  • White: N/A
  • Black or African American: N/A
  • American Indian or Alaska Native: N/A
  • Asian: N/A
  • Native Hawaiian or Other Pacific Islander: N/A
  • Unknown: N/A
Ethnicity (%)
  • Hispanic or Latino: N/A
  • Not Hispanic or Latino: N/A
  • Unknown: N/A
Geographic Region (%)
  • USA: N/A
  • International: N/A
  • Unknown: N/A
Scanner Manufacturer(s)
N/A
Scanner Model(s)
N/A
Model Accuracy
N/A
Model Sensitivity
N/A
Model Specificity
N/A
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
Unknown
Slice Thickness
Unknown
Contrast Use
Unknown
MRI Field Strength
Unknown
Reconstruction Kernel Used
Unknown
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
Unknown
All Products And Platforms from Disior Ltd