Medihub Prostate

JLK Inc.
Medihub Prostate Model Card
Product Details
Model Identifier
Manufacturer
JLK Inc.
Product
Medihub Prostate
Version
Unknown
Date Cleared
06/21/2024
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
Prostate MR image
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
MEDIHUB PROSTATE is an image processing software package that performs outlining, processing, viewing, and editing of prostate MR images. The software can support study review and analysis of prostate MR data with computed modules. The analysis result can be presented in various formats, including images overlaid onto source MR images and a structured report. MEDIHUB PROSTATE semi-automatically outlines the prostate based on MR images by contour, and it requires the user to edit with image manipulating tools and confirm the final result. The package provides additional functionalities including registered multiparametric-MRI viewing and combining MR sequences into a single image to support visualization. Edited PI-RADS report and semi annotated prostate region can be viewed in each single image in the final report. MEDIHUB PROSTATE is intended to be used by trained radiologists and urologists. Patient management decisions should not be made solely based on the analysis performed by MEDIHUB PROSTATE. Limitations: * MEDIHUB PROSTATE has been validated for use with Siemens 3T Vida and Skyra MRI machines. * MEDIHUB PROSTATE is also designed for use with the Siemens 3T T2 MRI series, supporting slice thicknesses ranging from 3.5 mm to 5 mm. * MEDIHUB PROSTATE has been tested on patients aged 55 years and above.
Intended User
Radiologists and urologists
Age
Adult
Anatomy
Pelvis
Modality
MR
Output
MEDIHUB PROSTATE semi-automatically outlines the prostate based on MR images by contour, and it requires the user to edit with image manipulating tools and confirm the final result. The package provides additional functionalities including registered multiparametric-MRI viewing and combining MR sequences into a single image to support visualization. Edited PI-RADS report and semi annotated prostate region can be viewed in each single image in the final report.
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
Both
Standalone Model Performance
Reference Standard (Ground Truth)
Interpretation by Reviewing Clinician
No. of Cases
114
Age Range (Years)
57 - 78
Sex (%)
Female: 0
Male: 100
Race (%)
White: 92
Black or African American: 6
American Indian or Alaska Native: 0
Asian: 0
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)
Siemens
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
3
No. of Cases
73
No. of Sites
Unknown
Output
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
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
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 JLK Inc.