(30 days)
The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections
- Supracondylar fractures, including those with intra-articular extension
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty
- Fractures distal to a hip joint
- Nonunions and malunions
The subject T2 Femoral Nail System is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, condyle screws/nuts and end caps.
The provided text is a U.S. FDA 510(k) summary for a medical device modification, specifically for the T2 Femoral Nail System. It describes the device, its intended use, and its substantial equivalence to a predicate device.
After reviewing the document, it's clear that it does not contain any information about acceptance criteria, study performance data, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance. The document is a regulatory submission for a device modification and asserts "comparable properties of the subject to the predicate device" but does not provide any detailed study or test results that would be necessary to answer the questions posed.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The necessary information for almost all parts of your request (1 through 9) is absent from this regulatory document.
§ 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.