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The X-PLO2R is a transportable, software-monitored device designed to be used by patients as a portable oxygen delivery system requiring high concentrations of oxygen on a supplemental basis. It is small, portable of continuous use in home, institutional, and travel/ mobile environments.

The X-PLO2R is a transportable, software-monitored device designed to be used by patients as a portable oxygen delivery system requiring high concentrations of oxygen on a supplemental basis. It is small, portable of continuous use in home, institutional, and travel/ mobile environments.

The provided document is a 510(k) Pre-market Notification letter from the FDA for a device called "X-PLO2R," a portable oxygen generator. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/software-driven medical devices.

The letter serves as official FDA clearance for the device, stating it is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements, such as registration, labeling, and manufacturing practices, but does not detail the technical performance studies that would typically be associated with software or AI.

Therefore, I cannot provide the requested information based on the text provided. The document focuses on regulatory approval based on substantial equivalence, not on a detailed analysis of a software's performance against specific acceptance criteria.

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