(80 days)
Sheeting is indicated for short term use for nasal splinting, wound dressings, scar coverings and temporary joint spacers.
For long term use, this device is indicated for tympanic membrane repair, dural covering, nasal septal repair, tendon anastamosis and neural repair, correction of strabismus, galea repair, orbital floor repair, hemodialysis shunt anchors, facilitation of osteogenesis, repair of urethral strictures, staged repair of omphalocoel and repair of orbital floor fractures.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device named "Medisil Silicone Sheeting," indicating that the device has been found substantially equivalent to a legally marketed predicate device.
The letter lists the indications for use but does not contain any details about performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information in the suggested format.
§ 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.