Liver ASSIST Virtual Parenchyma

GE HealthCare
Liver ASSIST Virtual Parenchyma Model Card

A 3D Visualization software solution designed to provide AI based virtual parenchymography to help physicians simulate injections dynamically and thus, perform liver embolization procedures with confidence.

Product Details
Model Identifier
Manufacturer
GE HealthCare
Product
Liver ASSIST Virtual Parenchyma
Version
vxtl_17.0-4.24
Date Cleared
10/22/2021
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
LIVER CBCT with intra arterial injection
Exclusion Criteria
Pediatrics
Instructions for Use
Indications for Use
Indication of Use
FlightPlan for Liver is a post processing software package that helps the analysis of 3D x-ray angiography images of the liver. Its output is intended as an adjunct means to help visualize vasculature and identify arteries leading to the vicinity of hyper vascular lesions in the liver. This adjunct information may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during the planning phase of embolization procedures.
Intended User
Physician
Age
Adult
Anatomy
Abdomen
Modality
3D-Angio
Output
Visualization of vascular structures as well as estimated distal liver regions adjacent to distal vessels. The selective display of vessels (Live Tracking) and the selective display of estimated distal liver regions (Virtual Parenchyma) are interactive with user’s cursor, based on the computed skeleton of the vessel tree segmentation for Live Tracking 
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
Stand-Alone Performance
Standalone Model Performance
Reference Standard (Ground Truth)
Interpretation by Reviewing Clinician
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
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)
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
Rib Fracture
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