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The Mini-Fixator for Colles Fractures are indicated for use with a Colles fractures requiring external fixator. The half pins are surgically implanted the remainder of the device is external.

The Mini-Fixator for Colles Fractures is intended for use in the repair of Colles fractures. The device is intended for single use only and is external with internal pins.

There are several pieces that are included in this device package. This also includes the instrument required. The pieces are the mini hammer, the distractor bar, half pins, drill bit, drill guide, clamp assembly, 3/32 x 5 drill bit, tommy bar, alignment guide, 2.5 mm screwdriver and silicone pin caps. These are packaged in a single container for single use and are sterile.

The provided text describes a medical device, the "Mini-Fixator for Colles Fractures," and its FDA 510(k) clearance. However, it does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies with acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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