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The Porex Nostril Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty, and/or primary and secondary rhinocheiloplasty.

A nasal retainer is used after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty, and/or primary and secondary rhinocheiloplasty to assist in keeping the nasal passages open and reduce swelling. It is a silicone U shaped with the legs of the U being tubes that are inserted into the nostrils. The device of this submission is the predicate device and is identical to the predicate device, in all aspects except for method of sterilization and labeling

The provided text is a 510(k) summary for a medical device called the "Porex Nostril Retainer." This document outlines the device description, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria, device performance studies, or details relevant to artificial intelligence or statistical methods typically found in studies proving device efficacy.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these elements are not present in the provided text.

The document is a regulatory submission for a physical medical device, not a software or AI-driven diagnostic tool, and thus does not contain the kind of performance data usually associated with AI/ML-based medical devices.

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