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The 8" ONE™ is designed to store, rapidly warm and maintain the temperatures of I.V. fluid bags and irrigation solution bags prior to their use. The 8" ONE™ also provides a visual and hardcopy documentation of vital data of the heating cycle for each solution bag as long as it is in the cabinet.

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This document is an FDA 510(k) clearance letter for a medical device called the "8™ One™ Warming Cabinet." It does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment.

The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing Medical Solutions, Incorporated to market it. The "Indications for Use" section describes what the device is for but does not include any performance metrics or study details.

Therefore, I cannot provide the requested information based on the provided text.

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