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The AOS Antegrade Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to 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 severe comminution and intraarticular extension; ipsilateral femur fractures; bone lengthening; fractures proximal to a total knee arthroplasty or prosthesis; fractures distal to a hip joint; nonunions and malunions; and fractures resulting from osteoporosis.

The AOS 6.5mm Fully Threaded Cancellous Screw is used in the AOS Antegrade Femoral Nail System, in conjunction with the AOS Antegrade Femoral Nail. The screw can be used in both recon and antegrade configurations and can be threaded in and locked to the nail.

The provided text describes a traditional 510(k) summary for a medical device called the "AOS 6.5mm Captured, Fully Threaded Cancellous Screw" and its associated "AOS Antegrade Femoral Nail System."

Based on the information provided, no acceptance criteria or studies proving device performance are described in the input text. This document is a regulatory submission summary for market clearance, focusing on demonstrating substantial equivalence to predicate devices rather than clinical performance testing.

Therefore, I cannot provide the requested information for the following reasons:

• No acceptance criteria are mentioned for the device's performance. The document focuses on regulatory classification and substantial equivalence based on indications for use, shape, design, and fundamental technology.
• No study is described that proves the device meets specific acceptance criteria. The text does not detail any performance tests (e.g., mechanical strength, durability, biological compatibility testing, or clinical outcome studies).

The key takeaway from the provided text regarding substantial equivalence is:
"Information presented supports substantial equivalence of the AOS 6.5mm Fully Threaded Cancellous Screw to the predicate devices. The proposed system has the same indications for use, is similar in shape and design, and has the same fundamental technology."

This statement confirms that the device is deemed equivalent based on its intended use and design characteristics compared to already cleared devices, not on explicit performance metrics against acceptance criteria.

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