(87 days)
The Synthes (USA) Adjustable Large Fixator System is intended for use in the treatment of conditions of the long bones including fractures, osteotomies, and other bone conditions amenable to treatment with a unilateral external fixator.
The Adjustable Large Fixator System consists of a pre-assembled, mechanically adjustable, unilateral fixator and an accessory, the Hybrid Adaptor. The fixator is a one-piece construct comprised of radiolucent plastic and metallic components. The vise clamps of the fixator accept 4.0-6.0 mm Schanz Screws. The Hybrid Adaptor is an accessory to the Adjustable Large Fixator that forms the connection between the fixator and the Synthes Hybrid Ring.
This 510(k) summary (K010344) for the Synthes Adjustable Large Fixator System does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets the acceptance criteria.
The provided document is a 510(k) summary, which is a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device. It focuses on device description, intended use, and comparison to predicate devices, rather than detailed performance study results against specific acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set size. The document's purpose is to establish regulatory equivalence, not to present a comprehensive performance study.
§ 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.