(27 days)
The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
This Special 510(k) submission is intended to address a line extension to the predicate Long Length Gamma® Nail. The existing Long Length Gamma® Nail is an intramedullary rod intended to be used in the fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The current design is cannulated, with a medial/lateral and anterior/posterior curve. The line extension involves increasing the distal diameter of the nail. In addition, two shorter length Gamma® Nail Lag Screws will be added to the system. Howmedica Osteonics intends to add the new designs of intramedullary rods to the current product line, thereby offering additional design options for the surgeon. The line extension to the Long Length Gamma® Nails are substantially equivalent to the existing design of Long Length Gamma® Nail which were determined substantially equivalent via the 510(k) process. The material used to manufacture the line extension to the Long Length Gamma® Nail is identical to that of the predicate. There is no change in intended use for the line extension to the Long Length Gamma® Nail when compared to the predicate device.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is a 510(k) summary for a line extension of the Long Length Gamma® Nail, detailing its identification, intended use, and substantial equivalence to a predicate device. It is a regulatory document rather than a scientific study report.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information. This information is not present in the provided context for the Long Length Gamma® Nail.
§ 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.