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The SECURE Screw is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The A.M. Surgical SECURE Screw is a stainless steel, cannulated, partially threaded, headless screw intended to be used for fracture fixation of small, long bones of the hands and feet. Screw threads provide compression to promote reunion of fracture fragments. The device is offered in five different lengths; 40mm, 45mm, 50mm, 55mm, and 60mm. All dimensions, excluding length, are the same among the different sizes. These varying lengths allow for personalized medical treatment of fractures geared toward each individual patient and different types of fractures. The device is manufactured out of a single piece of 316L VM (UNS-S31673) stainless steel, is provided sterile (via gamma radiation), and is not reusable or re-sterilizable. This device is intended for permanent implantation, but can also be removed. To install and remove the device from a patient, the F543 compliant T8 hexalobe drive connection on the screw head is used in conjunction with a commercially available guide wire, drill bit, and driver.

The provided text is a 510(k) summary for a medical device called the SECURE Screw, a bone fixation fastener. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against acceptance criteria in the context of an AI/human-in-the-loop system.

Therefore, I cannot extract the acceptance criteria and study details as requested for an AI system because this document does not pertain to the evaluation of an AI-powered device.

The document describes a traditional medical device (a screw for bone fixation) and its regulatory clearance process, which relies on demonstrating substantial equivalence to an already marketed device. This process primarily involves comparing design, materials, indications for use, and performance testing against established industry standards.

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