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Synthes 3.5mm LCP Hook Plate is indicated for fractures, osteotomies and non-unions of small bones including the ulna, radius, tibia and fibula, particularly in osteopenic bone.

The Synthes 3.5mm LCP Hook Plate is a low-profile, pre- contoured bone fixation plate intended for the treatment of fractures, osteotomies, and non-unions in small bones. The plates feature a preformed dual hook on one end and arc available in stainless steel and titanium.

This 510(k) summary describes a traditional medical device (bone fixation plate), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific performance metrics (like MRMC studies or human reader improvement with AI) is not applicable.

The 510(k) summary for the Synthes (USA) 3.5mm LCP Hook Plate focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use. There are no performance criteria or studies of the type requested for AI/ML devices.

Summary of the provided information:

• Device Name: Synthes (USA) 3.5mm LCP Hook Plate
• Intended Use: Fractures, osteotomies, and non-unions of small bones (ulna, radius, tibia, fibula), particularly in osteopenic bone.
• Predicate Device: Synthes One-Third Tubular DCL Plate
• Classification: Class II, §888.3030 - Single / multiple component metallic bone fixation appliance and accessories.

The document states "Information presented supports substantial equivalence" but does not detail a specific performance study with acceptance criteria in the context of AI/ML evaluation.

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