(90 days)
The Silicone Carving Block is designed to be used in acsthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.
Silicone Carving Blocks
This is a 510(k) premarket notification letter from the FDA to a medical device manufacturer. It primarily grants market clearance and does not contain the detailed study information you're asking for regarding acceptance criteria, performance data, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information because the provided document (K974482) is a regulatory approval letter and not a study report. It does not contain the specifics about acceptance criteria and the study that proves the device meets those criteria.
§ 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.