(169 days)
The iSR'obot MRI-US Fusion is a software application to be used by Clinicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of Magnetic Resonance and Ultrasound images for mapping planning information of the prostate gland and region of interest. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ delineation, region of interest delineation, landmark selection, measurements and data reporting.
The iSR'obot MRI-US Fusion (UroFusion) is a software application intended for use by Clinicians or Radiologist for 2-D and 3-D visualization, image registration and fusion of Magnetic Resonance and Ultrasound images for mapping planning of the prostate gland and region of interest, such as lesions, to provide "MRI-3D model" imaqe information. The "MRI-3D model" image information produced by this software acts as inputs to the iSR'obot Mona Lisa which allows the import of this "MRI-3D model" image information; and fusion of this model information together with the live ultrasound 3D-model image information.
Leveraging on the information available from both Magnetic Resonance (MRI) & Ultrasound modalities concurrently, the fusion results enable the clinicians to visualize the prostate and the region of interest (lesions); thus enabling fewer and more accurate targeted prostate biopsies to be taken as compared with "blind" saturated biopsies with ultrasound guidance alone.
UroFusion software system includes the following features:
- Access and display medical imaging studies from MRI DICOM data. .
- Provide for 2D contouring /3D modelling of the prostate gland. .
- Provide for 2D contouring / 3D modelling of tumour / lesions within the . gland.
- Provide for saving of patient "MRI-3D model" information together with ● the patient's MRI DICOM data.
- Provide for importing of patient "MRI-3D model" information together with relevant MRI DICOM data.
- Provide for the fusion of "MRI-3D model" information with the live . ultrasound 3D- model information for subsequent operations to be executed in iSR'obot Mona Lisa.
UroFusion can be deployed and utilized in commercially available computer platforms and operating systems; or as a standalone system.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating substantial equivalence to a predicate device (Multi-Modality Image Fusion, K120187) and performing verification and validation activities, including non-clinical performance evaluation and clinical evaluation through literature review.
The "reported device performance" is primarily qualitative, focusing on whether the UroFusion successfully fulfills its intended functions and is comparable to the predicate. The key performance demonstrated in the non-clinical testing is the measurement of "Hausdorff distance," which is a metric for comparing two point sets or shapes, indicating how far two surfaces are from each other. However, a specific acceptance criterion for Hausdorff distance (e.g., "Hausdorff distance
§ 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).