(160 days)
The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The Arthrex DynaNite Nitinol Staple is a Nickel Titanium (Nitinol) bone fixation device intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomies.
The provided text describes a 510(k) premarket notification for the "Arthrex DynaNite Nitinol Staple." This document focuses on demonstrating substantial equivalence to predicate devices, rather than proving a new device's absolute performance against specific acceptance criteria for a novel AI/software function.
Therefore, the information required to answer the prompt regarding AI/software device acceptance criteria and a study proving those criteria is not present in the provided text. The document pertains to a traditional medical device (a bone fixation staple), and the "Performance Data" section discusses mechanical properties, corrosion, and biocompatibility, not AI performance.
Hence, I cannot populate the requested tables and information.
§ 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.