(110 days)
The Compressyn™ Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus. ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.
The Compressyn™ Staple is a fully integrated system that consists of a stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical delivery device. The staple is offered in several sizes with barbs to prevent back out. It is a compression staple fixation device that is placed into two tissue segments using pre-drilled holes to provide stabilized fixation. The Compressyn™ Staple is provided sterile in a disposable tray with a drill bit and drill guide.
The provided text describes Dallen Medical's Compressyn™ Staple (K140358) and its substantial equivalence to previously cleared devices (K122871, K132875). However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about sample sizes, ground truth establishment, or expert involvement.
The document primarily focuses on the device's description, indications for use, and a declaration of substantial equivalence based on the device being "identical to the predicate and therefore has the same physical and technical characteristics." It mentions some testing of the preloaded mechanical delivery device for "impact force, staple delivery, compressive force and bond strength," but it does not provide any quantitative results or acceptance criteria for these tests.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about the study design elements you asked for, as this data is not present in 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.