(15 days)
The CAIRE Companion 5, Oxygen Concentrator, is Intended for the administration of supplemental oxygen up to 5 liters/minute. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Not Found
I am sorry, but based on the provided document, there is no information available regarding an acceptance criteria table, device performance report, or any study involving AI or human readers.
The document is a letter from the FDA regarding the 510(k) premarket notification for the "CAIRE Companion 5 Oxygen Concentrator." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. The "Indications for Use Form" specifies that the device provides supplemental oxygen up to 5 liters/minute and is not intended for life support or patient monitoring.
The document discusses regulatory compliance and the device's intended use, but it does not contain any data or discussion about:
- Acceptance criteria for device performance.
- Reported device performance metrics (e.g., accuracy, sensitivity, specificity).
- Any studies involving test sets, training sets, ground truth establishment, or expert reviews.
- AI algorithm performance, human-in-the-loop studies, or standalone algorithm performance.
- Sample sizes or data provenance for any studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
§ 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).