(42 days)
AOC" -L is indicated for use as an aqueous water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
AOC" -L Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.
AOC" -L Soluble Implant Material is comprised of a sterile aqueous mixture of watersoluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. AOC" -L Soluble Implant Material contains no other additives or colorants. AOC" -L Soluble Implant Material is formed of various weights ranging from 0.5 to 5 grams each.
AOC" -L Soluble Implant Material is provided sterile by irradiation and must not be resterilized.
This document does not describe an AI/ML-powered medical device and therefore the requested information regarding acceptance criteria and study proving device efficacy cannot be extracted in the context of AI/ML performance.
The document pertains to a 510(k) premarket notification for a medical device called "AOC™-L Soluble Implant Material." This device is a water-soluble implant material used as a space-occupying material during natural healing. The entire submission focuses on establishing substantial equivalence to a predicate device (AOC™ Soluble Implant Material, K081531) based on having the same intended use, fundamental scientific technology, and indication for use. The only stated difference is the addition of water to alter handling properties.
The document does not mention any AI or machine learning components, nor does it describe any performance metrics that would be relevant to an AI/ML device such as sensitivity, specificity, accuracy, or reader study outcomes. Therefore, it is impossible to provide the requested information.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.