Critical Care Suite with Endotracheal Tube Positioning AI Algorithm

GE HealthCare
Critical Care Suite with Endotracheal Tube Positioning AI Algorithm Model Card

Critical Care Suite with Endotracheal Tube Positioning AI Algorithm provides an accurate and automated measurement of ET Tube position on the X-ray device within seconds of image acquisition.

Product Details
Model Identifier
Manufacturer
GE HealthCare
Product
Critical Care Suite with Endotracheal Tube Positioning AI Algorithm
Version
2
Date Cleared
10/29/2021
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
Chest AP/PA X-ray
Exclusion Criteria
Non Chest and Lateral Chest X-rays
Instructions for Use
Not available
Indications for Use
Indication of Use
Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital x-ray system. Critical Care Suite with the Endotracheal Tube Positioning AI algorithm produces an onscreen image overlay that detects and localizes an endotracheal tube, locates the endotracheal tube tip, locates the carina, and automatically calculates the vertical distance between the endotracheal tube tip and carina. This information is also transmitted to the radiologist for review. Intended users include licensed qualified healthcare professionals (HCPs) trained to independently place and/or assess endotracheal tube placement and radiologists. Critical Care Suite with Endotracheal Tube Positioning AI Algorithm should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the X-ray image by a qualified healthcare professional. Critical Care Suite with the Endotracheal Tube Positioning AI Algorithm is indicated for adult-size patients.
Intended User
Radiologist
Age
Adult
Anatomy
Chest
Modality
XRAY
Output
Breathing Tube
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)
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
Unspecified
Scanner Manufacturer(s)
GE
Scanner Model(s)
AMX
No. of Sites
Unspecified
Model Accuracy
Unspecified
Model Sensitivity
99
Model Specificity
100%
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
Unspecified
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