(90 days)
The Image Analysis System is intended to provide a method of storing and providing remote viewing and analyzing access to diagnostic images via a LAN, the internet, or a modem. The system is also intended to provide the display of segmented anatomical structures based on the correlation of the image sets to atlas information. Examples of structures that may be segmented include but are not limited to: vertebral bodies, prostate, hippocampus, and the basal ganglia.
This submission describes a system to display, transfer, store, analyze and process patient image sets. The processing of image data includes the ability to segment anatomical structures.
This is a 510(k) summary for the "Image Analysis System" and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The provided documents are primarily for regulatory clearance based on substantial equivalence to predicate devices, rather than a performance study report.
Therefore, I cannot fulfill your request with the information provided. The document states that "The substantial equivalence was established by comparison of functions and features" with predicate devices, but it does not describe a performance study with acceptance criteria, sample sizes, or ground truth establishment.
To answer your questions accurately, a different type of document, such as a validation study report or a more detailed technical submission, would be required.
§ 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).