(189 days)
MR Contour DL generates a Radiotherapy Structure Set (RTSS) DICOM with segmented organs at risk which can be used by trained medical professionals. It is intended to aid in radiation therapy planning by generating initial contours to accelerate workflow for radiation therapy planning. It is the responsibility of the user to verify the processed output contours and user-defined labels for each organ at risk and correct the contours/labels as needed. MR Contour DL is intended to be used with images acquired on MR scanners, in adult patients.
MR Contour DL is a post processing application intended to assist a clinician by generating contours of organ at risk (OAR) from MR images in the form of a DICOM Radiotherapy Structure Set (RTSS) series. MR Contour DL is designed to automatically contour the organs in the head/neck, and in the pelvis for Radiation Therapy (RT) planning of adult cases. The output of the MR Contour DL is intended to be used by radiotherapy (RT) practitioners after review and editing, if necessary, and confirming the accuracy of the contours for use in radiation therapy planning.
MR Contour DL uses customizable input parameters that define RTSS description, RTSS labeling, organ naming and coloring. MR Contour DL does not have a user interface of its own and can be integrated with other software and hardware platforms. MR Contour DL has the capability to transfer the input and output series to the customer desired DICOM destination(s) for review.
MR Contour DL uses deep learning segmentation algorithms that have been designed and trained specifically for the task of generating organ at risk contours from MR images. MR Contour DL is designed to contour 37 different organs or structures using the deep learning algorithms in the application processing workflow.
The input of the application is MR DICOM images in adult patients acquired from compatible MR scanners. In the user-configured profile, the user has the flexibility to choose both the covered anatomy of input scan and the specific organs for segmentation. The proposed device has been tested on GE HealthCare MR data.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter for MR Contour DL:
1. Table of Acceptance Criteria and Reported Device Performance
Device: MR Contour DL
| Metric | Organ Anatomy Region | Acceptance Criteria | Reported Performance (Mean) | Outcome |
|---|---|---|---|---|
| DICE Similarity Coefficient (DSC) | Small Organs (e.g., chiasm, inner-ear) | ≥ 50% | 67.4% - 98.8% (across all organs) | Met |
| Medium Organs (e.g., brainstem, eye) | ≥ 65% | 79.6% - 95.5% (across relevant organs) | Met | |
| Large Organs (e.g., bladder, head-body) | ≥ 80% | 90.3% - 99.3% (across relevant organs) | Met | |
| 95th percentile Hausdorff Distance (HD95) Comparison | All Organs | Improved or Equivalent to Predicate Device | Improved or Equivalent in 24/28 organs analyzed; average HD95 of 4.7 mm ( |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).