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The SCARF THREAD-HEAD™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions. The SCARF THREAD-HEAD™ SCREW is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

The SCARF THREAD-HEAD™ SCREW is a cannulated thread-head screw made of a Titanium alloy. Screws come in lengths of 10-32 mm in 2 mm increments.

This document describes a medical device, the SCARF THREAD-HEAD™ SCREW, and its intended use. It does not contain the information requested about acceptance criteria, device performance, studies involving AI, or ground truth establishment for a training set. The provided text is a summary of safety and effectiveness for a bone fixation screw and focuses on its description, intended use, and comparison to predicate devices, along with a single mechanical test.

Therefore, I cannot populate the table or answer the questions based on the provided text. The document is about a physical medical device, not an AI or software-based device that would typically have the kind of performance metrics and study details you've requested.

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