(85 days)
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.
§ 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.