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The AOS Clavicle Plate System provides fixation for fractures, fusions, or osteotomies for the Clavicle.

The AOS Clavicle Plate System consists of bone plates and screws for fractures, fusions, and osteotomies of the Clavicle bone. The bone plates are pre-shaped to fit the curves and angles of the Clavicle and are provided in a range of curvatures and sizes. The plates accept both locking and nonlocking screws. The proposed new plates are shorter versions of the lateral and midshaft plates currently in the system. The 6 Hole Medium Midshaft Superior Clavicle Plate and 6 Hole Straight Midshaft Superior Clavicle Plate both come in right and left versions and follow the same basic curvature as that of the existing 8 Hole Medium and Straight Midshaft Clavicle Plates, respectively. The Short Lateral Superior Clavicle Plates come in right and left versions and follow the same basic geometry as the current lateral superior plates, with the addition of an elongated hole. The elongated hole will be used for provisional placement with the ability to adjust the plate positioning. All plates except for the short lateral plates have at least one bending notch. This notch feature is used for fine adjustment of the plate geometry in order to fit the plate more intimately with the bone surface.

The provided text is a 510(k) summary for the AOS Short Clavicle Plates. It describes a medical device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document states: "As detailed in the submission, the proposed plates do not present a worst-case scenario with respect to strength characteristics, and because of their similarity to the current plates, physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed plates and the predicate plates."

This indicates that the device was approved based on substantial equivalence to an existing predicate device (AOS Clavicle Plate System, K103513), due to similarities in:

• Indications for use
• Geometry and design
• Fundamental scientific technology
• Material (Ti-6Al-4V ELI, per ASTM F136)

Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving the device meets acceptance criteria, as this information is not present in the provided text. The approval was based on a comparison to a predicate device rather than a new performance study with specific acceptance criteria.

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