(246 days)
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
APTUS Wrist 2.5 System consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and non-locking. This submission includes additional lengths of non-locking screws. Plates have a low overall height, rounded edges, polished surfaces and incorporate TriLock Technology with use of TriLock (locking) screws. All plates are made from unalloyed titanium conforming to ASTM F67, and all screws are made from titanium alloy conforming to ASTM F136.
I am sorry, but the provided text is a 510(k) summary for a medical device (APTUS® Wrist 2.5 System), which describes its intended use, device description, and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, study details for a diagnostic or AI-powered device, or any of the other specific points you requested (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size).
Therefore, I cannot provide the requested table and study description based on the information given.
§ 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.