(121 days)
The emOx device is intended to generate oxygen of greater than 99.7% purity for emergency first aid administration.
emOx Portable Oxygen Generator
The provided document is a 510(k) clearance letter from the FDA for a device called "emOx Portable Oxygen Generator" (K984081). It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed information requested regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) clearance letter typically references that such information was provided by the manufacturer in their submission, but it does not reproduce the full study report or acceptance criteria within the letter itself. The letter focuses on the FDA's determination of substantial equivalence based on the submitted data.
Therefore, I cannot fulfill your request with the provided text. The requested information about acceptance criteria, study details, sample sizes, and ground truth would be found in the original 510(k) submission documentation, which is not included in this letter.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).