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510(k) Data Aggregation
K Number
K233196Device Name
Medihub Prostate
Manufacturer
Date Cleared
2024-06-21
(267 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JLK Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
MEDIHUB PROSTATE is an image processing software package for multi-parametric prostate MR image analysis. The analysis may assist trained radiologists in clinical interpretation of prostate MR studies. It can be accessed through a web browser, and provides the following main features:
- . A semi-automatic processing module that outlines the prostate region and performs multiparametric MRI image registration.
- . A user-interaction module in which the user can edit and approve the computed prostate outline and determine PSA density using serum PSA level.
- . A user-interaction module in which the user can view multi-parametric MRI images, and outline and analyze ROIs. This extension will also apply a mathematical operation on the input images to combine information from another MRI sequences into a single combination image.
- A semi-automatic processing module that collects all results for exporting and transferring back to the user.
All measurements are manual except for the prostate volume, which is semi-automatic and requires user review. The method for measuring prostate volume is straightforward and unaffected by patient demographics. Users have the option to outline the prostate either completely manually or with semi-automatic assistance. This device is not intended to be used for fully automatic prostate delineation. It does not involve any segmentation functions by itself. The Al functionality is limited to assessing the total prostate volume, without segmenting lesions.
In semi-automatic mode, our device employs an Al-based algorithm to initially outline the prostate volume, and then it requires the user to edit, review and approve. Additionally, the device calculates the total prostate volume. However, users are responsible for performing all other image annotations and measurements manually. This implies that the final decision should be confirmed by the user, and the user should not rely solely on the device's analysis.
Additional annotations and measurements: all calculated manually
- PI-RADS
- Location of seminal vesicles
- . Prostate zones
- . DWI and DCE graphs
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