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The Respironics SimplyGo Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel /mobile environments.

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I am sorry, but the provided documentation, which is an FDA 510(k) clearance letter for the "Respironics SimplyGo Oxygen Concentrator," does not contain the detailed information necessary to answer your request.

Specifically, this document focuses on the regulatory approval of the oxygen concentrator, stating that it is substantially equivalent to legally marketed predicate devices. It discusses general controls, regulations, and reporting requirements.

The document does not include information about:

• Acceptance criteria and reported device performance in a table format.
• Details of any specific study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Whether MRMC or standalone studies were performed, or their results.
• Training set details.

Therefore, I cannot fulfill your request based on the provided input.

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