(30 days)
The device is intended to be used in the management of segmental diaphyseal bone loss of either humerus or tibia or femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.
OsteoBridge® IDSF Intramedullary Diaphyseal Segmental Defect Fixation Rod System
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. The document appears to be an FDA 510(k) clearance letter for a medical device, the OsteoBridge® IDSF Intramedullary Diaphyseal Segmental Defect Fixation Rod System, outlining its regulatory classification and indications for use. It does not include any performance study data as would be found in a clinical or validation 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.