(142 days)
The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.
The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.
The provided text describes a medical device, the OrthoHelix™ Staple System, and its clearance process with the FDA. However, it does not include information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) performance evaluation.
The document is a 510(k) summary and an FDA clearance letter for a Class II medical device (bone staple). The information provided focuses on demonstrating substantial equivalence to predicate devices through engineering calculations, finite element analysis, and mechanical/corrosion testing. This type of submission generally does not involve clinical performance studies with human subjects or AI-based analyses.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related study details, as this information 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.