(68 days)
The SOLCO 4CIS® General Plate System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femur, pelvis, metacarpals, metatarsals, humerus, ulna, radius, hand and middle foot bones.
The SOLCO 4CIS & General Plate System consists of One-third Tubular plate, Small self compression plate, Reconstruction plate (Straight, Curved), Narrow self Small Sole Compression plate. SOLCO 4CIS® General Plate. SOLCO 4CIS® General Plate comproblem participants sizes of implants to accommodate the individual byother with from pure titanium material.
The provided document is a 510(k) summary for the SOLCO 4CIS® General Plate System, a bone fixation plate. It details the device, its intended use, and substantial equivalence to predicate devices. However, this document does not contain the information requested in the prompt regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The "Performance Data" section merely states: "Mechanical testing was conducted in accordance with ASTM F382 and Nicenames." This indicates that some form of performance testing was done, but it does not provide specific acceptance criteria or the results of those tests.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory submission details and intended use, not on the specifics of a performance study with detailed acceptance criteria and results.
§ 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.