qER
Qure.ai Technologies
Product Details
Model Identifier
Manufacturer
Qure.ai Technologies
Product
qER
Version
1.0
Date Cleared
06/17/2020
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
Patients aged > 21 years, Non-contrast head CT scans
Exclusion Criteria
Scans with artifacts and missing field of view
Instructions for Use
Not available
Indications for Use
Indication of Use
qER is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images. The device is intended to assist hospital networks and trained medical specialists in workflow triage by flagging the following suspected positive findings of pathologies in head CT images: intracranial hemorrhage, mass effect, midline shift and cranial fracture. qER uses an artificial intelligence algorithm to analyze images on a Stand-Alone Performance cloud-based application in parallel to the ongoing standard of care image interpretation.
Intended User
trained medical specialists
Age
Adult
Anatomy
Head
Modality
CT
Output
Intracranial hemorrhage, midline shift, mass effect or cranial fractures
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)
Interpretation by Reviewing Clinician
No. of Cases
1,320
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)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Aquilion;Somatom Emotion
No. of Sites
Unspecified
Model Accuracy
Unspecified
Model Sensitivity
ICH: 96
Model Specificity
ICH: 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
Predicate Device(s)
Contact Information
Contact Information
Point of Contact Name
Unspecified
Email
Unspecified
Additional Details
Related Use Cases
Unspecified