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The EBI Thermal Therapy System is intended to apply localized cold or heat therapy to body surfaces. The EBI Thermal Therapy System is designed to lower or raise the surface skin temperature by delivering water at a controlled temperature to the target site via a thermal pad. The system is designed for repeated uses in the hospital or home. The thermal pad is designed for single patient use.

The EBI Thermal Therapy System consists of a water delivery system, insulated hoses and a thermal pad. The water delivery system includes the following components: case, water pump, fan, water reservoir, thermal exchangers, electronic control module, display, and keypad. The EBI Thermal Therapy System operates on standard house current. A variety of pads, in different shapes and sizes, are available to accommodate different anatomical sites. Both sterile and nonsterile pads are available for use with the EBI Thermal Therapy System.

The provided text does not contain information about acceptance criteria or a study that proves a device meets specific acceptance criteria in the way described in the prompt. Instead, it is a 510(k) summary for the EBI Thermal Therapy System, focusing on its substantial equivalence to predicate devices.

The summary outlines:

• Intended Use: To apply localized cold or heat therapy to body surfaces.
• Device Description: Consists of a water delivery system, insulated hoses, and a thermal pad.
• Predicate Devices: Danninger Thermal-Max Thermal Therapy Unit and the InCare Hot/Ice System.
• Evidence of Substantial Equivalence: Comparative testing was performed between the EBI Thermal Therapy System and the Danninger Thermal-Max Thermal Therapy Unit, which "demonstrates that the systems have equivalent performance characteristics."

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth, as this information is not present in the provided document. The document describes a comparison to demonstrate substantial equivalence to an already legally marketed device, rather than a study against a pre-defined set of acceptance criteria for a novel performance claim.

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