(39 days)
The Hanson Medical Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery. The Hanson Gluteal Implant will be carvable, allowing the physician to customize the device shape for muscular defects.
Hanson Medical Gluteal Implants are intended for augmentation, or as reconstruction to minimize muscular defects. The Hanson Gluteal Implant is carvable, allowing the physician to adapt the device shape to individual patient contours. They are manufactured using heat cured, medical grade, two part, liquid silicone system (LSR), silicones that meet FDA requirements for replacement of Dow's discontinued medical grade silicone analogues.
Hanson Gluteal Implants will be offered non-sterile. The implants will be packaged in autoclavable peel pouches labeled with a detachable traceability tab for patient record files. Autoclave sterilization details are provided in the package insert. The implants are finally boxed with package insert materials and labeled for shelving and shipping traceability.
This document is a 510(k) summary statement for the Hanson Medical Gluteal Implant. It states that the device is substantially equivalent to previously marketed devices (Hanson Medical Silicone Carving Block, AART, Inc and Silimed LLC Gluteal Implants) based on similar materials, manufacturing methods, and dimensions.
However, the provided text does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. It is a regulatory submission focused on demonstrating substantial equivalence, not on presenting performance data from a specific study.
Therefore, I cannot fulfill your request for an acceptance criteria table, study sample sizes, expert details, adjudication methods, MRMC study results, standalone performance, or training set information because that information is not present in 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.