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CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, non-unions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.

CREEDTM Cannulated Screws consists of subject components that will be available in thread diameters ranging from Ø2.5mm to Ø7.4 mm and lengths ranging from 14-120mm. They are either headed or headless compression. All screws are self-drilling and self-tapping. The screws are offered in configurations that include a Titanium alloy Ti-6AL-4V ELI (ASTM F136) screw and a Titanium alloy Ti-6AL-4V ELI (ASTM F136) screw with an outer layer of Zeniva ZA-600 PEEK (ASTM F2026). A variety of instrumentation is offered as part of the kit to facilitate delivery of the screws. The screws are provided sterile via Gamma irradiation.

This document is a 510(k) Premarket Notification for the CREED™ Cannulated Screws, a medical device for bone fixation. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, but does not describe acceptance criteria for an AI/ML device or a study proving its performance.

Therefore, I cannot provide the requested information about acceptance criteria or a study related to AI/ML device performance from the provided text. The document is for a traditional medical device (cannulated screws) and does not involve AI/ML.

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