EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

Ever Fortune.AI Co., Ltd.
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System Model Card
Product Details
Model Identifier
Manufacturer
Ever Fortune.AI Co., Ltd.
Product
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Version
Unknown
Date Cleared
04/04/2022
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
DICOM chest X-ray images in PA view
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software for use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject. The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR ofa chest X-ray image in posterior-anterior (PA) chest view using an artificial intelligence algorithm. Intended users ofthe software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. The system is suitable for adults between 20 -80 years of age. Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases.
Intended User
Physicians or other licensed practitioners i
Age
Adult
Anatomy
Chest
Modality
XRAY
Output
Cardiothoracic ratio
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)
Unknown
No. of Cases
840
Age Range (Years)
20 - 80
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
0
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)
Unknown
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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