Search Results

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 Osteotomies
• · Subtalar Fusion
• · First Metatarsal-Cuneiform Lengthening Arthrodesis
• Calcaneocuboid 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 oval and teardrop 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 and Calcaneocuboid 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.

This submission describes a medical device, the Trigon™ HA Stand-Alone Wedge Fixation System, and its claim of substantial equivalence to predicate devices. However, the provided document does not contain information regarding acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than on demonstrating performance against specific clinical acceptance criteria through new clinical studies.

Therefore, I cannot provide the requested information for points 1 through 9.

Summary of missing information specifically related to acceptance criteria and performance studies:

• No acceptance criteria tables: The document does not specify any quantitative acceptance criteria for device performance.
• No reported device performance data: While there is a mention of "Engineer analysis comparing device characteristics," no specific performance metrics or data are provided.
• No clinical study details: There is no mention of a test set, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or ground truth types and their establishment.
• No training set details: Information on training set size or how ground truth was established for a training set is not present.

The document focuses on comparing the proposed device's characteristics (materials, intended use, processes) to those of previously cleared predicate devices to establish substantial equivalence. It explicitly states, "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System." and "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)". This indicates a non-clinical, comparative assessment rather than a clinical performance study against defined acceptance criteria.

Ask a specific question about this device