(71 days)
The Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.
Silicone Blocks
The provided document is an FDA 510(k) clearance letter for "Silicone Blocks." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or details typically found in a clinical study report.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. This document is a regulatory communication, not a performance study report.
§ 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.