qER-Quant

Qure.ai Technologies
qER-Quant Model Card
Product Details
Model Identifier
Manufacturer
Qure.ai Technologies
Product
qER-Quant
Version
1.0
Date Cleared
07/30/2021
FDA Submission No.
Category
MIMPS
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
The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a set of Non-Contrast head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on NCCT images. qER-Quant provides volumes from NCCT images acquired at a single time point and provides a table with comparative analysis for two or more images that were acquired on the same scanner with the same image acquisition protocol for the same individual at multiple time points. The qER-Quant software is indicated for use in the analysis of the following structures: Intracranial Hyperdensities, Lateral Ventricles and Midline Shift.
Intended User
Unspecified
Age
Adult
Anatomy
Head
Modality
CT
Output
Brain anatomy
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
375
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;LightSpeed;Optima;Revolution;Somatom Emotion
No. of Sites
Unspecified
Model Accuracy
Unspecified
Model Sensitivity
Not provided
Model Specificity
Not provided
Additional Performance Metrics
ICH (Mean[SD]: 6.56 (7.33) ml, DICE Score: 0.75 (0.72 - 0.78)), Midline Shift (Mean [SD]: 1.37 (1.23) mm) Left Lateral Ventricle (Mean [SD]: 2.09 (1.88) ml, DICE Score: 0.79 (0.78 - 0.81)) Right Lateral Ventricle (Mean [SD]: 2.18 (1.72) ml, DICE Score: 0.75 (0.73 - 0.77))
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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