(120 days)
Citieffe Titanium Nailing System is intended for insertion into the medullary canal of a specific long bone – humerus and femur -for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.
Citieffe Titanium Nailing System
I'm sorry, but this document is a 510(k) clearance letter for the Citieffe Titanium Nailing System. It focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance studies or acceptance criteria of an AI or software device.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for a device performance study cannot be extracted from this document. This document is not a study report.
§ 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.