Bone VCAR

GE HealthCare
Bone VCAR Model Card

Bone VCAR provides an automated spine labeling application based on a deep learning model. It can identify and label segments of the spine or the entire spine in a matter of seconds.

Product Details
Model Identifier
Manufacturer
GE HealthCare
Product
Bone VCAR
Version
Unknown
Date Cleared
04/08/2019
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
CT Spine
Exclusion Criteria
Unspecified
Instructions for Use
Not available
Indications for Use
Indication of Use
Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by providing tools to label the spine and optimize the display of anatomy within the CT image. Bone VCAR is designed to support the clinician in visualization of the spine, by providing initial identification of vertebrae to assist in report dictation. The software also assists the user by providing optimized display settings for easier identification of anatomy to facilitate fast image review and reporting of findings. Bone VCAR may be used for multiple care areas and is not specific to any disease state. It can be utilized during the review of various types of exams including trauma, oncology, and routine body.
Intended User
Clinicians
Age
Unknown
Anatomy
Spine
Modality
CT
Output
� Multiplanar Reconstruction (MPR) displays of axial, sagittal, coronal, oblique, x-section and curved views which can be displayed in thin/thick, Average, Maximum Intensity Projection (MIP), Minimum intensity Projection (MinIP), Volume Rendering (VR) modes � Display of anatomical labels automatically with editing capability of all labels such as the spine. � Display of curved views automatically and editing capability of curved views through anatomical regions such as the spine for enhanced display options � Access to all standard volume viewer tools for measuring distances, areas, Hounsfield unit values and annotating within the images � Synchronization of views when multiple series are loaded with spine labeling for all series loaded.
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
Unknown
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: Unknown
  • International: Unknown
  • Unknown: Unknown
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)
All
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
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