(331 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 is a series of modular intramedulary rods segments that may be used as either proximal or distal segments. The segments are designed to be attached together to form a complete intramedullary rod using semiciteular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod and bridge the bonaliped with middle section of either humerus, tibia or femur. Reducing bushings allow the use of different diameter nails proximally and distally to provide optimal fit of the intract and with the medillary canal of the proximally and and distal segments of the bone to be fixed. All components of the OsteoBridge® Humeral IDSF -Intramedullary Segment Fixation Rod System are manufactured from Ti-6Al-4V Titanium Alloy conforming to ASTM F-136. The device is divided into three categories/product size ranges that are suitable for each boney application; humerus, tibia or femur (see tables below).
The provided text describes a medical device, the OsteoBridge® IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System, and does not contain information about an AI/ML powered device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies that prove an AI device meets these criteria.
The document details the device description, intended use, mechanical testing methods, and standards followed for this intramedullary fixation rod system. It is a traditional medical device submission, not an AI/ML submission.
Therefore, I cannot provide the requested information for the following reasons:
- No AI/ML device: The document pertains to a physical medical device (intramedullary rods) and does not mention any artificial intelligence or machine learning components.
- No acceptance criteria for AI performance: Since there's no AI component, there are no acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
- No study proving AI performance: The mechanical testing described is for the physical device's structural integrity, not for algorithm performance.
Please provide a document related to an AI/ML medical device if you wish for me to extract information on its acceptance criteria and a study proving it meets those 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.