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The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.

TriMed Bone Plates is a system of plates, screws and surgical accessories used in the fixation of small and long bone fractures. The plates and screws are all made of stainless steel.

The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications for the TriMed Bone Plates.

The documents are a 510(k) summary and the FDA's clearance letter for the device. These documents primarily focus on:

• Device Description: The TriMed Bone Plates are a system of plates, screws, and surgical accessories made of stainless steel for small and long bone fracture fixation.
• Intended Use: Fixation of fractures to the Tibia, Fibula, Ulna, Radius, and Humerus.
• Substantial Equivalence: The product compares itself to existing predicate devices (K013655 Acumed Congruent Bone Plate System and K051735 Smith & Nephew PERI-LOC). The FDA clearance is based on this claim of substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study details based on the provided text. The 510(k) clearance process for devices like bone plates often relies on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria in the same way a novel diagnostic or AI-driven device might.

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