(55 days)
Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
Vanguard Reprocessed External Fixation Devices are previously used noninvasive orthopedic devices that have been cleaned, inspected, tested, and packaged by Vanguard Medical Concepts, Inc. External Fixation Device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation. External fixation elements consist of components such as straight rods, telescoping rods, rod-to-rod and pin-to-rod couplings and clamps. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.
The provided document is a 510(k) Summary of Safety & Effectiveness for Vanguard Reprocessed External Fixation Devices. It declares substantial equivalence to predicate devices but does not contain specific acceptance criteria or a study proving that the device meets such criteria.
The document states:
"Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective."
"Vanguard Reprocessed External Fixation Devices are essentially identical to the Original Equipment Manufacturer (OEM) devices. No changes are made to the currently marketed OEM device specifications and the Reprocessed External Fixation Devices possess identical technological characteristics."
Based on the provided text, I cannot complete the requested table and details because the information is not present. The document focuses on demonstrating substantial equivalence based on the identical technological characteristics and intended performance to predicate devices rather than providing detailed acceptance criteria and a study with specific performance metrics.
Therefore, the questions cannot be answered from 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.