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The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

• Cotton (opening wedge) Osteotomies of the Medial Cuneiform
• Evans Lengthening Ssteotomies
• Subtalar Fusion
• First Metatarsal-Cuneiform Lengthening Arthrodesis

The Trigon HA wedges are intended for use with ancillary fixation.

The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular and oval shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.

When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating, except for the Lapidus Wedges which will require ancillary fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Trigon HA Wedge Fixation System." This document primarily focuses on demonstrating the substantial equivalence of the new device to existing predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria for AI performance or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within this document. This type of information is typically found in clinical trial reports or performance validation studies for devices that rely on algorithms or AI for diagnostic or prognostic purposes.

The document states:

• "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System."
• "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)."
• "The results of this comparison indicate that the Trigon HA Stand-Alone Wedge Fixation System is substantially equivalent to the predicate devices."

This indicates that the "study" demonstrating the device meets requirements was an engineering analysis to show equivalence to existing devices, not a performance study as would be done for an AI-powered diagnostic tool. The device is a physical implant, not a software-driven diagnostic or treatment planning system that would require the kind of performance metrics you've asked about.

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