(72 days)
This device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.
The Gamma® Locking Nail System consist of a family of femoral nails, lag screws set screws rno cap screws for intramedullary nailing of proximal femoral fractures. This line extension is a and ouplification of the currently marketed Gamma nails cleared under various 510(k) notifications. mounter, or the builter, rounder nails will retain the major design features of the previously cleared Gamma nails and will be made from Orthinox® stainless steel.
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.
The document is a 510(k) summary for a Gamma® Locking Nail System line extension. It primarily focuses on demonstrating substantial equivalence to previously marketed devices, rather than presenting a detailed performance study with acceptance criteria.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.