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The Tarsa-Link Wedge Fixation and screws are intended to be used for internal bone fractures, fusions, or osteotomies in the ankle and foot, such as:

· Opening wedge osteotomies of Hallux Valgus

· Evans lengthening osteotomies

· Metatarsal/cuneiform arthrodesis

The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot. The implant is available in a range of sizes and footprints to suit the individual anatomical conditions of the patient. Additionally, the wedge is fabricated and manufactured with two different materials: 1) Polyetheretherketone (PEEK) with tantalum markers and titanium pins (Ti 6Al-4V ELI). 2) Titanium (Ti 6Al-4V ELI).

The implant is hollow to permit packing with autogenous bone graft to help fusion. The implant has two pockets to permit placement of titanium bone screws (Ti 6A1-4V ELI) through the wedge to provide internal fixation.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the TARSA-LINK Stand-Alone Wedge Fixation System components with components from any other system or manufacturer. The TARSA-LINK Stand-Alone Wedge Fixation System components should never be reused under any circumstances.

This document is a 510(k) premarket notification for a medical device and thus does not contain information about the acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. This documentation is for a physical medical device, the "TARSA-LINK Wedge Fixation System," which is a metallic bone fixation appliance.

The relevant sections of the document discuss:

• Indications for Use: For internal bone fractures, fusions, or osteotomies in the ankle and foot.
• Technological Characteristics: Substantially equivalent to predicate systems in design, materials, and indications for use.
• Material: Manufactured from PEEK or Titanium, with tantalum markers and titanium pins.
• Performance Data: "Benchtop testing and Finite Element Analysis was presented to demonstrate the substantial equivalency of the Tarsa-Link Wedge Fixation System."

There is no mention of an AI/ML component in this device, nor any acceptance criteria or studies related to AI/ML performance. Therefore, I cannot provide the requested information.

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