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Oxygen concentration by means of molecular sieve technology, yielding supplemental product oxygen in conformance with official USP designation "Oxygen 93 Percent", and supplemental delivery for oxygen therapy.

Note: The intended use of this system is as a secondary oxygen source. The primary oxygen source for the facility is normally provided by liquid oxygen and distributed in a gaseous state via (typically) 'H' or 'K' supply cylinders in a conventional configuration. (reference: NFPA 99C,1996, fig. 4-3.1.1.6)

FreshAir System

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets specific acceptance criteria. This document is a 510(k) clearance letter from the FDA for a device named "FreshAir System," stating that it has been determined to be substantially equivalent to legally marketed predicate devices.

The document discusses the regulatory classification, general controls, and compliance requirements for the device. It also provides the indications for use. However, it does not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample size or data provenance for a test set.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size or ground truth establishment for a training set.

Therefore, I cannot provide the requested information from this document.

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