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The StealthSERVER™ Image Storage and Communication System is used to store and provide remote viewing access to diagnostic images via a LAN, the internet or modem. In addition, the system can be used to remotely set surgical plans for stereotactic surgery that are compatible with and can be accessed by the StealthStation® Treatment Guidance Platform.

This submission describes a network server system that provides remote access to digital image sets for the purpose of reviewing the images and, optionally, for developing and storing a stereotactic surgical plan that is compatible with the StealthStation® Image Guided Treatment Platform. The submission includes the capability of the StealthStation® System to retrieve the surgical plans and image sets from the network server.

This 510(k) submission for the StealthSERVER™ Image Storage and Communication System does not contain the information requested regarding acceptance criteria or a study proving the device meets said criteria.

The provided document is a summary and an FDA clearance letter, which focuses on:

• Device identification: StealthSERVER™ Image Storage and Communication System.
• Intended Use: Storing and providing remote viewing access to diagnostic images, and remotely setting surgical plans compatible with the StealthStation® Treatment Guidance Platform.
• Substantial Equivalence: Stating that the device was shown to be substantially equivalent to other commercially available medical image storage, review, and communication systems. The FDA clearance letter confirms this finding.

There is no mention of the following in the provided text:

• A table of acceptance criteria or reported device performance.
• Details about a study, including sample sizes, data provenance, ground truth establishment, or expert involvement.
• MRMC comparative effectiveness studies or standalone performance.

Therefore, I cannot provide the requested information based on the given input.

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