Search Results

The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for:

• Temporary stabilization of open or closed acute fractures with soft tissue injuries; .
• . Definitive stabilization of open or closed fractures where open or alternative closed treatment is undesirable or otherwise contraindicated;
• Stabilization of fractures in the context of polytrauma; .
• Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; .
• Arthrodesis and osteotomies with associated soft tissue problems; .
• Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure;
• Neutralization of fractures stabilized with limited internal fixation; .
• . Stabilization of non-unions; and
• . Intraoperative temporary stabilization tool to assist with indirect reduction.

The XtraFix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.

The provided document describes the XtraFix External Fixation System, a medical device for stabilizing bone fractures. It does not contain information about a study with acceptance criteria and device performance in the context of an AI/algorithm-driven device. The document is a 510(k) summary, which is typically a premarket notification for a medical device demonstrating substantial equivalence to a legally marketed predicate device.

Specifically, the document states:

• "The principles of operation of the XtraFix External Fixation System are the same as for the predicates."
• "The XtraFix External Fixation System was characterized and evaluated according to the requirements outlined in FDA Guidance document, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Testing confirmed the device can be used in an MR environment under predetermined conditions. Therefore, the term "MR Conditional" can be used to describe the system in accordance with the guidance document."
• "All evaluations determined that the XtraFix External Fixation System is substantially equivalent to the predicate devices."

This indicates that the "study" conducted was primarily focused on demonstrating MR compatibility and confirming the device's technological characteristics are similar to existing predicate devices, rather than a performance study with acceptance criteria for an AI-powered diagnostic or therapeutic tool.

Therefore, I cannot populate the requested table and information points as they pertain to AI/algorithm performance and ground truth, as that information is not present in the provided text. The device is a physical external fixation system, not a software-based AI device.

Ask a specific question about this device