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The ACE BioWin Tibial Nailing System is indicated in reamed and unreamed applications for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, metaphyseal fractures and epiphyseal fractures.

The BioWin Tibial Nailing System consists of an intramedullary nail, cortical screws, end cap, and an optional bioresorbable window. The nails, screws and end cap are all manufactured from Titanium (Ti-6Al-4V ELI) and the optional bioresorbable window is made from a lactide/glycolide copolymer.

The provided text is a 510(k) summary for the "ACE BioWin Tibial Nailing System." This type of document is for regulatory clearance of a medical device, not a typical study report proving device performance against specific acceptance criteria in the manner of an AI/ML device or a diagnostic accuracy study.

Therefore, the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set details) is not applicable to this document.

Explanation:

• Acceptance Criteria & Reported Performance: For this type of device (intramedullary nail), acceptance isn't typically based on quantifiable performance metrics from a clinical study in the way a diagnostic algorithm would be. Instead, "acceptance" for 510(k) clearance is determined by demonstrating substantial equivalence to predicate devices already on the market. This means showing that the new device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness.
• Study Design Elements (Sample Size, Experts, Adjudication, MRMC, Standalone, Ground Truth): These concepts apply to studies designed to evaluate diagnostic accuracy, treatment effectiveness, or the performance of a software algorithm. The 510(k) summary is a regulatory filing, not a scientific publication detailing a de novo study to establish performance benchmarks.
• Training Set: This is a concept relevant to machine learning/AI development, which is not applicable to a physical bone fixation device.

In summary, the provided document does not contain the specific information requested because it is a regulatory filing for substantial equivalence of a physical medical device, not a performance study for an AI/ML product or diagnostic test.

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