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The Therapy Concepts Water Circulating Treatment System will be used to pump chilled or room temperature water through a plastic pad that is placed on a mattress underneath the user and in so doing, will provide cold temperature therapy intended to temporarily assist in the localized reduction of minor swelling and pain. Pre-chilled water will be provided by adding ice cubes and water to the reservoir. The cooling rate is adjusted by adjusting the rate of flow of the water through the plastic pad.

The Therapy Concepts Water Circulating Treatment System will consist of five discreet modules. A reservoir module holding 1.5 liters of water. A low voltage DC pump with integral connection tubing. A wall mounted power supply to provide 7,5 volts DC to power the pump. A plastic/foam pad with connecting tubing, containing channels through which water is circulated and a form fitted sewn nylon carrying case.

The provided text is a summary of safety and effectiveness for a medical device submitted in 1996. It describes the device, its intended use, and its predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

Therefore, I cannot fulfill your request for that information based on the input provided. The text focuses on the device description and substantial equivalence, not on performance testing or clinical study results.

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