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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.

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