(48 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.