(210 days)
The Carnét Oxygen Demand Valve is intended to be used for the delivery of 100% oxygen in response to the patient's inspiratory effort on the order of a physician. This product is designed for use with adult and paediatric patients in hospitals, ambulances or other managed clinical environments. This product is not intended to be used with infants or neonates.
Oxygen Demand Valve
This looks like a 510(k) clearance letter for an Oxygen Demand Valve and not documentation related to an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML is not available.
The document discusses the regulatory clearance of a medical device (Oxygen Demand Valve) by the FDA, based on substantial equivalence to a predicate device. It does not contain information about:
- Acceptance criteria for an AI/ML model's performance.
- A study proving an AI/ML device meets specific performance criteria.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, which are all specific to AI/ML device evaluations.
Instead, it confirms that the device is cleared for marketing based on its intended use as an Oxygen Demand Valve for delivering 100% oxygen to adult and pediatric patients in a medical setting.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).