(174 days)
The Synthes Suprapatellar Insertion Instruments are part of the Synthes Tibial Nail System EX. The Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.
The Synthes (USA) Suprapatellar Insertion Instruments consist of aiming arms, protection sleeves, trocars, and accessory instruments which are intended to facilitate the surgical approach for the insertion of intramedullary nail implants of the Synthes Tibial Nail System EX.
The provided text describes a medical device, the Synthes Suprapatellar Insertion Instruments, and its regulatory approval process, specifically a 510(k) premarket notification. However, it does not contain information about acceptance criteria, device performance metrics, or experimental study details typically found in a clinical trial or performance study report.
The document states that in vitro studies under simulated use were conducted, but it does not provide any specific results, acceptance criteria, or a detailed description of these studies. It only broadly concludes that "the results support the conclusion that there are no effects of the modification subject to this premarket notification on the safety and effectiveness of the Synthes Tibial Nail System EX."
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
The document is a 510(k) summary and the FDA's clearance letter, focusing on substantial equivalence to predicate devices rather than a detailed performance study as would be required for a novel device or significant change that fundamentally alters performance characteristics.
In summary, the provided text does not contain the information necessary to fulfill your request regarding acceptance criteria and a study proving the device meets those 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.