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The OxyBox System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitis ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.

OxyBox is a topical bandage system that incorporates a disposable oxygen concentrator. It consists of three separate component parts: (1) the oxygen concentrator, (2) the sterile cannula and (3) the bandage or wound dressing. Items (2) and (3) are medical grade commercial products that Oxyfast Corporation obtains from device manufacturers or distributors. The oxygen concentrator is a single patient, one time use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen (balance moisture) for seven days at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.

The provided text is a 510(k) summary for a medical device called OxyBox. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The section titled "7. PERFORMANCE TESTING" only states: "Testing was conducted to validate that the OxyBox performed according to its specifications. In addition, animal testing was conducted that demonstrated that topical oxygen delivered by the OxyBox provides increased epithelization compared to a control."

This is a high-level statement without any details about specific acceptance criteria, study design, sample sizes, or results.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided document.

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