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The Synthes 3.5mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients.

The Synthes 4.5mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients.

The 3.5mm and 4.5mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

The Synthes Curved Narrow and Broad LCP Plates are available in stainless steel and titanium, and consist of limited-contact profile plates in 3.5 mm and 4.5mm narrow and broad sizes. The plates feature Dynamic Compression Plate (DCP) holes combined with locking screw holes. The 3.5mm plates accept 3.5mm cortex and locking screws and 4.0 mm cancellous screws, and the 4.5mm plates accept 4.5 mm cortex screws, 4.0mm and 5.0mm locking screws, 4.5 mm cannulated screws, 5.0 mm periprosthetic screws, and 6.5 mm cancellous screws.

This document is a 510(k) summary for a medical device called "Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad Locking Compression Plates (LCP)". It is a regulatory submission for premarket notification to the FDA, asserting substantial equivalence to an existing device.

Based on the provided text, the document does not describe acceptance criteria for software performance or a study proving software meets such criteria. This document is for a physical medical device (bone plates for fracture fixation), and the information presented is related to its mechanical properties, materials, and intended use, not software performance.

Therefore, the requested information regarding acceptance criteria for a device's (software's) performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available within this document. The document primarily focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use for mechanical fixation.

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