CT Lung Ventilation Analysis Software (CT:V)
4DMedical Limited
Product Details
Model Identifier
Manufacturer
4DMedical Limited
Product
CT Lung Ventilation Analysis Software (CT:V)
Version
Unknown
Date Cleared
11/16/2023
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
CT Images of lung
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
CT: V software is a non-invasive image processing technology that measures volume changes from paired inspiration-expiration CTs to quantify and visualize regional and global ventilation. These regional measures are derived entirely from the lung tissue displacement and lung volume change between the paired inspiration-expiration chest CTs. CT: V is for use in adult patients. Quantification and visualizations are provided in the form of a report. CT: V may be used when physicians need a better understanding of a patient's lung function and/or respiratory condition.
Intended User
Unknown
Age
Adult
Anatomy
Chest
Modality
CT
Output
CT:V measures ventilation captured in the CTs by directly measuring the motion field of the lung tissue at thousands of points using a form of three-dimensional motion tracking. This motion tracking quantifies the expansion of lung tissue, and hence airflow (i.e. ventilation) is determined. These regional lung motion and ventilation measurements are used to provide quantitative outputs and color maps showing ventilation within a segmented region. An Analysis Report is generated for each completed workflow which is returned to the requesting physician. The ventilation data presented in the CT:V Report provides the user with additional functional information that may assist in characterizing the patient.
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)
Unknown
No. of Cases
32
Age Range (Years)
26 - 78
Sex (%)
- Female: Unknown
- Male: Unknown
- Unknown: Unknown
Race (%)
White: 63
Black or African American: 6
Asian: 3
Native Hawaiian or Other Pacific Islander: 22
Black or African American: 6
Asian: 3
Native Hawaiian or Other Pacific Islander: 22
Ethnicity (%)
Hispanic or Latino: 22
Geographic Region (%)
- USA: Unknown
- International: Unknown
- Unknown: Unknown
Output
Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
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)
Unknown
Slice Thickness
Unknown
Contrast Use
Unknown
MRI Field Strength
Unknown
Reconstruction Kernel Used
Unknown
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Predicate Device(s)
Contact Information
Contact Information
Point of Contact Name
4DMedical
Email
Additional Details
Related Use Cases
Unknown