Embo ASSIST AI

GE HealthCare
Embo ASSIST AI Model Card

Embo ASSIST with Virtual Injection is a 3D visualization software solution designed to help clinicians simulate injections dynamically, and thus perform embolization procedures with confidence.

Product Details
Model Identifier
Manufacturer
GE HealthCare
Product
Embo ASSIST AI
Version
vxtl_17.0-4.24
Date Cleared
03/21/2023
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
CBCT with intra arterial injection
Exclusion Criteria
Pediatrics
Instructions for Use
Indications for Use
Indication of Use
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature during the planning phase of embolization procedures. FlightPlan for Embolization is not intended to be used during therapy delivery. The output includes segmented vasculature, and selective display of proximal vessel and distal vessels from a reference point determined by the user. User-defined data from the 3D X-ray angiography images may be exported for use during the guidance phase of the procedure. The injection points should be confirmed independently of FlightPlan for Embolization prior to therapy delivery
Intended User
Clinicians
Age
Adult
Anatomy
Whole Body
Modality
3D-Angio
Output
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature during the planning phase of embolization procedures. FlightPlan for Embolization is not intended to be used during therapy delivery. The output includes segmented vasculature, and selective display of proximal vessel and distal vessels from a reference point determined by the user. User-defined data from the 3D X-ray angiography images may be exported for use during the guidance phase of the procedure. The injection points should be confirmed independently of FlightPlan for Embolization prior to therapy delivery.
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unspecified
Age Range (Years)
Unspecified
Sex (%)
  • Female: Unspecified
  • Male: Unspecified
  • Unknown: Unspecified
Output
Unspecified
Race (%)
  • White: Unspecified
  • Black or African American: Unspecified
  • American Indian or Alaska Native: Unspecified
  • Asian: Unspecified
  • Native Hawaiian or Other Pacific Islander: Unspecified
  • Unknown: Unspecified
Ethnicity (%)
  • Hispanic or Latino: Unspecified
  • Not Hispanic or Latino: Unspecified
  • Unknown: Unspecified
Geographic Region (%)
  • USA: Unspecified
  • International: Unspecified
  • Unknown: Unspecified
Scanner Manufacturer(s)
Unspecified
Scanner Model(s)
Unspecified
Model Performance
Study Type
Performance Testing Type
Both
Standalone Model Performance
Reference Standard (Ground Truth)
Unspecified
No. of Cases
Unspecified
Age Range (Years)
Unspecified
Sex (%)
  • Female: Unspecified
  • Male: Unspecified
  • Unknown: Unspecified
Race (%)
  • White: Unspecified
  • Black or African American: Unspecified
  • American Indian or Alaska Native: Unspecified
  • Asian: Unspecified
  • Native Hawaiian or Other Pacific Islander: Unspecified
  • Unknown: Unspecified
Ethnicity (%)
  • Hispanic or Latino: Unspecified
  • Not Hispanic or Latino: Unspecified
  • Unknown: Unspecified
Geographic Region (%)
  • USA: Unspecified
  • International: Unspecified
  • Unknown: Unspecified
Output
N/A - segmentation on 100% of cases
Scanner Manufacturer(s)
GE
Scanner Model(s)
Unspecified
No. of Sites
Unspecified
Model Accuracy
Unspecified
Model Sensitivity
N/A not diagnostic application
Model Specificity
N/A not diagnostic application
Reader Study Performance
No. of Readers
3
No. of Cases
Unspecified
No. of Sites
Unspecified
Output
N/A - segmentation on 100% of cases
Age Range (Years)
Unspecified
Sex (%)
  • Female: Unspecified
  • Male: Unspecified
  • Unknown: Unspecified
Race (%)
  • White: Unspecified
  • Black or African American: Unspecified
  • American Indian or Alaska Native: Unspecified
  • Asian: Unspecified
  • Native Hawaiian or Other Pacific Islander: Unspecified
  • Unknown: Unspecified
Ethnicity (%)
  • Hispanic or Latino: Unspecified
  • Not Hispanic or Latino: Unspecified
  • Unknown: Unspecified
Geographic Region (%)
  • USA: Unspecified
  • International: Unspecified
  • Unknown: Unspecified
Scanner Manufacturer(s)
GE
Scanner Model(s)
Unspecified
Model Accuracy
Unspecified
Model Sensitivity
N/A not diagnostic application
Model Specificity
N/A not diagnostic application
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
Unspecified
Slice Thickness
Unspecified
Contrast Use
Unspecified
MRI Field Strength
Unspecified
Reconstruction Kernel Used
Unspecified
Alternative Choices
Alternative Choices
Previous Version(s)
Unspecified
Contact Information
Contact Information
Point of Contact Name
Unspecified
Email
Unspecified
Additional Details
Related Use Cases
Unspecified
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