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Synthes 1.5mm Headless Compression Screws are indicated for fixation of intra-articular and extra-articular fractures, avulsions, non-unions, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints.

The Synthes 1.5mm Headless Compression Screws are solid bone fixation screws featuring a partially threaded shaft and threaded head. The screws are available in stainless steel and titanium.

The provided text is a 510(k) summary for a medical device called "Synthes (USA) 1.5mm Headless Compression Screws." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a study for acceptance criteria of an AI/ML powered device.

Therefore, the information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement for an AI/ML device is not present in the provided text. The document is typical for a traditional medical device submission, which relies on engineering and material testing, and comparison to predicate devices, rather than clinical performance studies with AI components.

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