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The Howmedica® Titanium Hoffmann® Fixation Pin System is intended to be used in conjunction with a rigid external supporting frame for immobilization open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

The Howmedica® Titanium Hoffmann® Fixation Pin System consists of half pins and transfixing pins available in a range of overall lengths, thread lengths and in shank diameters ranging from 1.5mm to 6mm. The half pins and transfixing pins are available in self-drilling and blunt tip configurations. The Howmedica® Titanium Hoffmann® Fixation Pins are designed to ease bone penetration and minimize risk of friction thermal necrosis, thereby facilitating secure bone purchase and stable fixation of the fracture.

The Howmedica® Titanium Hoffmann® Fixation Pins are inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame for immobilization of unstable fractures.

This document is a 510(k) summary for a medical device called the Howmedica® Titanium Hoffmann® Fixation Pin System. It describes the device, its intended use, and states that its substantial equivalence to previously marketed devices is based on equivalence in intended use, materials, design, and operational principles.

However, the provided text does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is primarily a regulatory filing (510(k)) indicating that the device has been found substantially equivalent to predicate devices, allowing it to be marketed. It does not include the detailed technical study information you've requested.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.

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