qXR-PTX-PE
Qure.ai Technologies
Product Details
Model Identifier
Manufacturer
Qure.ai Technologies
Product
qXR-PTX-PE
Version
Unspecified
Date Cleared
08/22/2023
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
Chest Xray , Age ≥ 22 years
Exclusion Criteria
Radiographs that do not contain the entire lung field
Instructions for Use
Not available
Indications for Use
Indication of Use
qXR-PTX-PE is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images
for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). qXR-PTX-PE uses an
artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level
output available in the PACS/workstation for worklist prioritization or triage.
As a passive notification for prioritization-only software tool within standard of care workflow, qXR-PTX-PE does not
send a proactive alert directly to the appropriately trained medical specialists. qXR-PTX-PE is not intended to direct
attention to specific portions of an image or to anomalies other than pleural effusion and/or pneumothorax. Its results are
not intended to be used on a stand-alone basis for clinical decision-making.
Intended User
Unspecified
Age
Adult
Anatomy
Chest
Modality
XRAY
Output
Pneumothorax and Pleural Effusion
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
No. of Sites
Unspecified
Model Accuracy
Unspecified
Model Sensitivity
95%
Model Specificity
PTX: 96
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
Predicate Device(s)
Contact Information
Contact Information
Point of Contact Name
Unspecified
Email
Unspecified
Additional Details
Related Use Cases
Unspecified