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The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, nonunions, and malunions of the bones of the forefoot, midfoot, and hand in patients 2 years of age and older in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The DePuy Synthes 2.0 mm Quick Insertion Screws (Ql Screws) are twist-off style screws comprised of a screw and post which are intended to separate at a predefined location (the breakpoint) as the screw is implanted into bone. The screws are offered with an external thread diameter of 2.0 mm and in lengths ranging from 11 mm to accommodate varying patient anatomy and fracture patterns in the foot and hand. The screws are made of a titanium alloy (Ti-6Al-7Nb) in accordance with ASTM F1295.

The provided text is a 510(k) summary for a medical device (DePuy Synthes 2.0 mm Quick Insertion Screws) and does not contain information about an AI/ML-based device or a study involving human readers and AI assistance.

Therefore, I cannot extract the requested information to describe acceptance criteria and a study proving a device meets acceptance criteria using AI/ML-related performance metrics. The document focuses on establishing substantial equivalence to predicate devices based on material properties, mechanical performance, and intended use for bone fixation screws.

Specifically, the document states:

• "No clinical performance data is provided in this submission." (Section 8)
• The non-clinical performance data provided relates to mechanical testing of the screws (insertion torque, axial pullout, bending strength), not AI/ML performance.

Therefore, I cannot fill out the requested table or answer the questions related to AI/ML study design, ground truth establishment, sample sizes for AI training/testing, or expert involvement in AI model evaluation.

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