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The I.T.S. Olecranonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal ulna (olecranon) in the elbow. Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, & 4 simple fractures, and Type 5a, 5b, 5c, & 6 complex fractures (comminuted) of the proximal ulna (olecranon).

The I.T.S. Olecranonplate with Angular Stability is a low-profile universal left and right titanium 8, 10, and 12 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 3.5mm Cortical screws of various lengths are self-tapping and are interchangeable in use to lock the plate to the dorsal shaft of the ulna. The Olecranonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) Summary of Safety and Effectiveness for a medical device called "Olecranonplate with Angular Stability." It describes the device, its intended use, and its substantial equivalence to other legally marketed devices.

Specifically, the text includes:

• Device Description: The I.T.S. Olecranonplate with Angular Stability is a low-profile universal titanium plate with various length cancellous self-tapping and head locking stabilization screws, and cortical screws. It is made from CP titanium and 6-4 alloyed titanium.
• Intended Use/Indications for Use: Fixation of complex intra- and extra-articular fractures, osteotomies, nonunions, malunions, and various types of simple and complex fractures of the proximal ulna (olecranon).
• Basis of Substantial Equivalence: It is substantially equivalent to Acumed Olecranon Plate, Synthes Curved Reconstruction Plate, and Zimmer Zuelzer Hook Plate for fracture of the Olecranon.
• Summary of Safety and Effectiveness: States that the device is "shown to be safe and effective for use in fracture fixation of the proximal ulna (olecranon) in the elbow," but does not provide details of any study or acceptance criteria used to demonstrate this.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study's methodology as this information is not present in the given text.

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