(71 days)
The treatment of simple anterior (front) nosebleeds by application of a noseclip to the external nose in adults and children. Not for use on infants.
Existing respiratory noseclip is to be used to treat simple anterior (front) nosebleeds.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) submission and FDA clearance letter for a nosebleed noseclip. It discusses the device's intended use, classification, and substantial equivalence to predicate devices, but it does not detail specific performance metrics, study designs, or data to demonstrate "acceptance criteria" other than regulatory compliance.
Therefore, I cannot provide the requested table or answer the questions regarding sample size, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies based on the input text.
§ 874.4100 Epistaxis balloon.
(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.