Critical Care Suite 2.0

GE HealthCare
Critical Care Suite 2.0 Model Card

Critical Care Suite is a collection of on-device, AI algorithms that integrate seamlessly with your existing X-ray workflow and assist you in delivering the highest quality care to patients.

Product Details
Model Identifier
Manufacturer
GE HealthCare
Product
Critical Care Suite 2.0
Version
1
Date Cleared
08/12/2019
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
AP/PA Chest X-rays
Exclusion Criteria
Non Chest and Lateral Chest X-rays
Instructions for Use
Not available
Indications for Use
Indication of Use
Computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite identifies images with critical findings to enable case prioritization or triage in the PACS/workstation.
Intended User
Clinicians
Age
Adult
Anatomy
Chest
Modality
XRAY
Output
Pneumothorax
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
84
Model Specificity
93
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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