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The TransCu O2 low dose tissue oxygenation system is intended for use with wound dressings to treat the following: Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions Pressure ulcers Infected residual limbs Skin grafts Burns Frostbite

TransCu O2 is a low dose tissue oxygenation system for the treatment of wounds such as venous leg ulcers, diabetic foot ulcers and pressure ulcers. TransCu O2 is intended for use with wound dressings. TransCu O2 consists of a handheld electrochemical oxygen concentrator, an oxygen delivery extension set and a wound site oxygen delivery cannula. The TransCu O2 device incorporates enhanced fuel cell chemistry, utilizing a Proton Exchange Membrane to electrochemically generate the low dose pure oxygen. The battery operated device is lightweight, portable and can be worn discretely, functioning in remote communication with the wound site through long microbore tubing. TransCu O2 extracts oxygen from room air; concentrates the oxygen through the PEM; and then creates an oxygen rich environment by increasing the available oxygen at the wound site under the dressing.

The provided text describes a medical device, TransCu O2, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document is a regulatory filing for a medical device (TransCu O2) and primarily focuses on its substantial equivalence to a predicate device (OxyBox System - K023456). It outlines the device's description, intended use, indications, and classification.

The "Performance Testing" section simply states: "Bench testing validates that the TransCu O2 performs according to its specifications." This is a general statement and does not provide any specific acceptance criteria, study details, performance metrics, or data.

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication, or comparative effectiveness studies, as these details are not present in the provided text.

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