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The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, 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 is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 10L/min. The nasal cannula are not sold with the device, users need to purchase the accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4, and it is not recommended to use humidification bottles. The maximum altitude the subject device can operate without degradation of concentration is 2000m.

I am sorry, but based on the provided text, I cannot extract the specific acceptance criteria and study details as requested. The document is a 510(k) summary for an Oxygen Concentrator, which primarily compares the subject device to a predicate device and outlines non-clinical tests performed. It does not contain sections detailing acceptance criteria for specific performance metrics with reported results, sample sizes for test sets, expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone performance studies, types of ground truth used, or details about the training set.

The document states:

• "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, there is no information about a study that would include elements like test set sample sizes, ground truth establishment, expert adjudication, or MRMC studies for this oxygen concentrator.

The "Performance Comparison" table in the document provides technical specifications and comparisons to the predicate device, but these are not presented as "acceptance criteria" with "reported device performance" in the format typically used for studies validating diagnostic or AI-based devices. The reported values are descriptive technical specifications rather than outcomes from a performance study against predefined acceptance criteria.

Therefore, I cannot provide the requested table and details because the provided text does not contain a study demonstrating device performance against explicitly defined acceptance criteria in the manner you described.

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