(79 days)
The titanium alloy Mini plate is provided non-sterile. The device is intended to treat fractures of various bones, including the clavicle, scapula, pelvis, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and plialanges).
The Mini plate is device, which is fastened to bone for purpose of providing fixation. The device is principally differentiated by its function. Thus there is various types and sizes of bone fixation plates. The Mini plate is geometry shape as follows: Straight, L-shaped, T-shaped, H-shaped, Condylar, Cloverleaf, Calcaneal, and Straight Reconstruction. The plate must be used for various sizes of screw onto bone fixation. The device range in thickness from 0.9 to 2.8 mm, width from 3.8 to 15.2 mm, length from 17 to 262 mm, and hole number from 3 to 22 holes.
I am sorry, but the provided text only contains regulatory information and a description of the device (Syntec-Taichung Non-sterile Titanium Alloy Mini Plate). It does not include any information regarding acceptance criteria, study details, performance data, or ground truth establishment for the device.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets the acceptance criteria. The document is primarily a 510(k) clearance letter from the FDA, confirming substantial equivalence to a predicate device.
§ 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.