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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.

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