qXR-CTR

Qure.ai Technologies
qXR-CTR Model Card
Product Details
Model Identifier
Manufacturer
Qure.ai Technologies
Product
qXR-CTR
Version
1.0
Date Cleared
09/22/2023
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
Chest X-ray , for Adults ≥ 22 years
Exclusion Criteria
Image that include motion artifacts, scans with missing field of view
Instructions for Use
Not available
Indications for Use
Indication of Use
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities. The system is suitable for adults ≥ 22 years of age. The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases.
Intended User
Unspecified
Age
Adult
Anatomy
Chest
Modality
XRAY
Output
Cardiac Diameter and Thoracic Diameter -Cardio-thoracic ratio
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;Philips;Siemens
Scanner Model(s)
DRX-1;DRX-Revolution
No. of Sites
Unspecified
Model Accuracy
Unspecified
Model Sensitivity
Not provided
Model Specificity
Not provided
Additional Performance Metrics
Cardic Diameter- Root Mean Squared Error (95% CI) in mm- 7.55 (6.96, 8.38), Mean Absolute Error (SD) in mm-5.66 (5.0) Thoracic Diameter -Root Mean Squared Error (95% CI) in mm- 5.43 (4.94, 6.09), Mean Absolute Error (SD) in mm-4.04 (3.63) CTR-Root Mean Squared Error (95% CI) in mm- 0.03( 0.02, 0.03), Mean Absolute Error (SD) in mm-0.02 (0.02)
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)
All
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
All Products And Platforms from Qure.ai Technologies