(124 days)
The Acumed Hand Plating System is intended for the management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.
The Hand Plating System consists of plates, locking screws, lag screws, and k-wires. Plates are available in a variety of shapes to accommodate varying fracture patterns and/or patient anatomy. The plates come in thicknesses of 0.8 mm to 1.3 mm. The locking screws and lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 5 mm to 20 mm. The lag screws and k-wires are used for fixation independent of the plates. The plates are made of titanium per ASTM F-67. The screws, lag screws, and the k-wires are made of titanium alloy per ASTM F136. All plates and screws are provided sterile and non-sterile.
The provided text describes a 510(k) submission for the Acumed Hand Plating System, which is a medical device for orthopedic fixation. It does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based device.
The document explicitly states: "The non-clinical testing enclosed in this submission includes static and cyclic performance testing and engineering analysis." This refers to mechanical and engineering tests, not studies related to algorithm performance or human-in-the-loop improvements.
Therefore, for your request regarding AI/algorithm acceptance criteria and studies, the provided text does not contain the necessary information. It is a traditional medical device submission focused on substantial equivalence to existing predicate devices based on design, materials, and mechanical performance.
§ 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.