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The Small Orthopedic Fixation System is provided non-sterile. The implants by the External Fixation Instrument may be used for highly comminuted closed fracture of hand, wrist, foot and tarsus ; for severe open fractures; for complex soft-tissue damages; or for dislocated joint fractures.

The Small Orthopedic Fixation System makes up of instrument and implants. The instrument is utilized with the implants. The implants are divided two kinds of styles: Schanz Screw, and Kirschner Wire. The dimension of the Schanz Screw ranges in thread diameter from 1.6 to 3.0 mm, thread length 15 mm, and total length 150, 200 mm; The dimension of Kirschner Wire with Threaded Tip ranges in thread diameter from 3.0/4.0 mm, total length from 80 mm.

This 510(k) summary does not contain information on acceptance criteria, a study proving device performance against such criteria, or details regarding sample sizes, ground truth establishment, or expert involvement.

The document is a submission for a non-sterile Small Orthopedic Fixation System and focuses on demonstrating substantial equivalence to a predicate device (Electro-Biology -- EBI Small External Fixator (S/E/F/)) based on similar design, sizes, materials, and appliance, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The document is primarily a regulatory submission demonstrating substantial equivalence to an existing device, which is a different type of evaluation than a performance study against predefined acceptance criteria.

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