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The K-SYSTEMS Work Station is intended for maintaining temperature of gametes and/or embryos at or near body temperature. The work station also includes features to humidify and maintain a constant pH environment for the gametes and/or embryos. Additionally the work station is flushed with steribenair.

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The provided text is a 510(k) clearance letter from the FDA for a device called "K-SYSTEMS Work Station." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report or a detailed submission summary.

The letter is primarily focused on regulatory clearance and states the intended use of the device: "maintaining temperature of gametes and/or embryos at or near body temperature. The work station also includes features to humidify and maintain a constant pH environment for the gametes and/or embryos. Additionally the work station is flushed with sterilized air."

Therefore, I cannot provide the requested information. The necessary details for answering your questions are not present in the provided FDA clearance letter.

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