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The Synthes LCP Radial Head Plate System is indicated for extra-articular and intra-articular fractures of the proximal radius and for multi-fragmented radial neck fractures.

The Synthes LCP Radial Head Plate System consists of radial head rim and neck plates. The plates are pre-contoured to match the anatomy of the proximal radius with a limited contact low profile design. The plates feature locking combination holes and round locking holes which accept 2.0 and 2.4 & 2.7 mm cortex screws, and 2.4 mm locking screws. The System will be available in Stainless Steel, CP Titanium and Titanium Alloy

This document is a 510(k) premarket notification for the Synthes (USA) LCP Radial Head Plating System, which is a device for bone fixation. As such, it does not contain the kind of performance study details requested in your prompt (acceptance criteria, sample size, expert information, etc.). These types of studies are typically associated with devices that involve diagnostic or AI-driven analysis, where performance metrics are critical and need rigorous validation against ground truth.

For a mechanical device like a bone plate system, the "acceptance criteria" for regulatory clearance are primarily focused on:

• Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves showing comparable materials, design, intended use, and mechanical properties.
• Biocompatibility: Ensuring the materials used are not harmful to the body.
• Sterility (if applicable): Demonstrating that the device can be sterilized and maintained sterile until use.
• Mechanical Testing: Verifying the structural integrity and performance of the device under simulated physiological conditions (e.g., strength, fatigue, torsional resistance).

The document mentions:

• Predicate Device: Synthes LCP Distal Radius Volar Plate (This is key to demonstrating substantial equivalence).
• Device Description: Details on the plates, materials (Stainless Steel, CP Titanium, Titanium Alloy), screw types, and design features.
• Intended Use: Specific types of fractures it's designed to treat.

Since this is a 510(k) submission for a bone fixation device, the information you've requested regarding AI/diagnostic performance studies is not applicable to this document. There is no mention of an algorithm, human readers, ground truth established by experts for diagnostic purposes, or MRMC studies.

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