(74 days)
Synthes 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal - phalangeal applications (in foot). The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot.
Synthes 3.0 mm Cannulated Screw and Threaded Washer are manufactured from 316L stainless steel or Ti-6Al-7Nb. Synthes 3.0 mm Cannulated Screw and Threaded Washer are provided to the user sterile. Gamma Radiation will be used to sterilize the device.
This document describes medical devices (cannulated screws and threaded washers) and their intended use, rather than an AI/ML device or software. Therefore, the questions related to acceptance criteria, study design, expert involvement, and ground truth for an AI/ML system are not applicable.
The document focuses on comparing the 3.0 mm and 2.7 mm cannulated screws and threaded washers manufactured by Synthes, primarily based on "mechanical testing." It states that the 3.0 mm device is considered "at least equivalent" to the 2.7 mm device based on this testing.
Therefore, I cannot provide answers to the requested information because the input text is not about an AI/ML device or a study assessing its performance against predefined acceptance criteria using a test set, ground truth, or expert interpretations.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.