(60 days)
The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.
The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf PCs running Windows 2000/XP operating systems and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Angiography MIP, Vessel Tracking and Tissue Definition.
This submission is a Special 510(k) for software modifications to an existing device, MediPrime, a Radiology Reading and Reporting Station. The modifications include added features for Angiography MIP, Vessel Tracking, and Tissue Definition. The summary does not contain information on acceptance criteria or a study proving device performance because the modifications do not affect the intended use, alter the fundamental scientific technology, or raise new issues of safety or effectiveness. Therefore, a comprehensive study as typically described for new device clearances demonstrating performance against acceptance criteria is not provided.
Specifically, the document states: "The modified device contains added features, including Angiography MIP, Vessel Tracking and Tissue Definition." and "The modifications to the MediPrime do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification was to software. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness."
Because this is a Special 510(k) for minor software modifications to an already cleared device, detailed performance metrics against acceptance criteria and dedicated clinical study data for device performance as a standalone algorithm are generally not required or provided in the summary. The focus is on demonstrating that the modifications do not introduce new risks or alter the previously established substantial equivalence.
Therefore, the requested information elements related to acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are largely not applicable or not provided in this type of submission.
§ 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).