Viz Aneurysm, Viz ANX

Viz. ai, inc.
Viz Aneurysm, Viz ANX Model Card
Product Details
Model Identifier
Manufacturer
Viz. ai, inc.
Product
Viz Aneurysm, Viz ANX
Version
Unknown
Date Cleared
02/18/2022
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
CT Head
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected aneurysms during routine patient care. Viz ANEURYSM uses an artificial intelligence algorithm to analyze images and highlight studies with suspected aneurysms in a Stand-Alone Performance application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Analyzed images are available for review through the Stand-Alone Performance application. When viewed through the Stand-Alone Performance application the images are for informational purposes only and not for diagnostic use. The results of VizANEURYSM, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Radiologists who read the original medical images are responsible for the diagnostic decision. Viz ANEURYSM is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis. Viz ANEURYSM is limited to detecting aneurysms at least 4mm in diameter.
Intended User
Radiologist
Age
Unknown
Anatomy
Head
Modality
CT
Output
Triage and fla studies with suspected aneuyrsms
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)
Interpretation by Reviewing Clinician
No. of Cases
315
Age Range (Years)
50 - 70
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: 100
International: 0
Output
Positive: 21% Negative: 79%
Scanner Manufacturer(s)
Canon\Toshiba;GE;Siemens
Scanner Model(s)
Aquilion;BrightSpeed;Aquilion PRIME;LightSpeed VCT;Optima Ct660;Revolution Evo;Revolution HD;Sensation 64;Somatom Definition As+;Somatom Edge Plus;Somatom Perspective
No. of Sites
2
Model Accuracy
96 - 0
Model Sensitivity
93% (95% CI: 83%, 98%)
Model Specificity
89% (95% CI: 85%, 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)
All
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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