(52 days)
The Caff Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Calf Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.
Calf Implant (Silicone Carving Blocks)
The provided text is a 510(k) clearance letter from the FDA for a Gluteal Implant (later identified as a Calf Implant in the "Indications for Use" section). It confirms substantial equivalence to a predicate device.
However, the document does not contain any information about acceptance criteria or the study that proves the device meets those criteria. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on presenting detailed performance study data against specific acceptance criteria in the format requested.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (which may be part of a 510(k) submission but is not included in this clearance letter), a clinical study report, or a detailed device specification.
§ 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.