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The Trident Fusion Implant has the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

The Vilex Trident Fusion Implant is a single-piece cannulated bone screw intended for the fixation of PIP joints in lesser toes and digits. The device is offered straight or with a 10° bend at the joint. It is available in either stainless steel or titanium.

The provided text is a 510(k) Summary for the Vilex Trident™ Fusion Implant. This document is a premarket notification to the FDA, demonstrating that a new device is as safe and effective as a legally marketed predicate device.

It does not contain information about acceptance criteria, device performance, or human study results. The document focuses on establishing substantial equivalence based on indications for use, material, sizes, shapes, and technological characteristics compared to predicate devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding studies with human participants, expert ground truth, sample sizes, or MRMC studies, as none of this information is present in the provided text.

The closest information to "device performance" is the statement repeated under "Technological Characteristics" and "Substantial Equivalence" that: "The technological characteristics for the Trident Fusion Implant are the same as the characteristics of the predicate devices." and "The design features of the Trident Fusion Implant are substantially equivalent to the design features of other predicate devices previously cleared for market." This implies that its performance is expected to be similar to legally marketed devices.

The document states that "The safety and effectiveness of the Trident Fusion Implant are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." However, the details of this "analysis data" proving safety and effectiveness are not included in the provided text.

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