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Cannulated Screw and Double Compression Cannulated Screw are intended for the treatment of fractures, and arthrodesis of bones with the appropriate screw size.

The Cannulated Compression Taper Screw (2.5-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.

The Cannulated Compression Taper Screw (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, ostectomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula.

Cannulated Screws are implantable medical devices developed for application in osteosynthesis, with the purpose of reducing, compressing, aligning, stabilizing, and fixing different types of fractures, in small, medium, and large bones, of lower and upper limbs, and can be used in isolated form or associated with washers. This submission also includes the corresponding washers for Cannulated Screws.

The screws have a hexagonal connection for a wrench and can be found in three different models: Cannulated Screw, Double Compression Cannulated Screw and Cannulated Compression Taper Screw. These devices are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, being provided in non-sterile condition.

The provided text is a 510(k) Premarket Notification from the FDA regarding "Cannulated Screws." It details the device's indications for use, technological characteristics, and performance data. However, this document does not contain information about an AI/ML-driven medical device, a study involving human readers or expert ground truth, or an AI algorithm's performance.

The "Performance Data" section discusses mechanical properties testing of the physical screws (torsional properties, driving torque, axial pullout strength, chemical and mechanical properties) against ASTM standards. It concludes that the device presents safety and efficacy in terms of its mechanical properties, but this pertains to the physical product, not a diagnostic or AI-assisted system.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided document does not pertain to such a device.

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