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The Oxygen concentrator provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.

The oxygen concentrator adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.

The provided text is a 510(k) summary for an Oxygen concentrator (K222920). It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications. It does not describe acceptance criteria for an AI/ML powered medical device or a study involving such a device. The device in question is a physical oxygen concentrator, not an AI software.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study to prove a device (specifically, an AI/ML medical device) meets those criteria, as the document does not pertain to such a device or methodology.

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