PROView DL

GE HealthCare
PROView DL Model Card

PROView DL leverages deep learning for automated prostate segmentation to deliver consistent quantification results, regardless of who is processing. The system has a guided workflow for simple and standardized assessment that includes an intelligent display of a multi-parametric prostate MR series along with a clinical history of the patient's PSA levels.

Product Details
Model Identifier
Manufacturer
GE HealthCare
Product
PROView DL
Version
Unknown
Date Cleared
11/17/2020
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
MR prostate
Exclusion Criteria
Unspecified
Instructions for Use
Not available
Indications for Use
Indication of Use
PROView is an aiding tool for the clinicians to review multi-parametric prostate MR images following PI-RADS guidelines. It displays acquired and reformatted data for visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions. Measurements and associated scoring are included in a report for communication to referring physicians.
Intended User
Clinicians
Age
Unknown
Anatomy
Pelvis
Modality
MR
Output
provide an automatic segmentation of the prostate on MRI T2 weighted acquisitions. It is a routine anatomical acquisition (as opposed to functional MRI), routinely done by the clinicians for prostate cancer assessment, as it is part of PIRADS guidelines. The algorithm provides a fully automatic segmentation of the prostate, based on a deep learning model.
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
Unknown
Age Range (Years)
Unknown
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: 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
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
Unknown
All Products And Platforms from GE HealthCare