(88 days)
Specialty Surgical Products Silicone Sheeting is intended for a variety of medical purposes both in short term and long term applications. For short term applications for use are: for nasal splinting, wound dressings, managment of hypertrophic or keloid scarring, to prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus, temporary joint spacers and laboratory uses. For longterm application the indications for use are: for nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair of omphalocele, for lengthening extraocular muscles in select cases of strabismus, as a protective sheathing to help facilitate neural regeneration and tendon anastomosis, as a protective sheathing to help facilitate osteogenesis, guided tissue regeneration between teeth and gingival margin, or external ear canal for example
Silicone Elastomer Sheeting
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for testing or training, data provenance, expert participation, adjudication methods, or comparative effectiveness studies.
The document is a 510(k) clearance letter from the FDA for a device called "Silicone Elastomer Sheeting." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its approved indications for use.
Such a clearance letter generally does not contain the detailed study results and acceptance criteria that would be submitted to the FDA during the 510(k) application process. This document is the FDA's decision, not the applicant's submission.
Therefore, I cannot populate the table or answer the specific questions you've posed about the study and acceptance criteria based solely on the provided text.
§ 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.