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The Great Toe Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful MTP joint.

The Great Toe Implant System is a one piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to replace the base of the proximal phalanx and provide a smooth articular surface for the adjacent metatarsal head. It is available in several sizes to accommodate variations in anatomy. Primary fixation is via a press fit.
Materials: The devices are manufactured from CoCrMo alloy per ASTM and ISO standards,
Function: The system functions to provide pain relief and improved function to the first metatarsal joint that has been damaged by inflammatory arthritis.

The provided text is a 510(k) summary for a medical device (Great Toe Implant System) seeking FDA clearance. It does not contain specific acceptance criteria, a study proving device performance against such criteria, or any of the detailed information requested in the prompt regarding a clinical study or AI performance evaluation.

The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the United States. This process typically involves comparing the new device's design, materials, manufacturing process, and intended use to a legally marketed predicate device, rather than conducting new clinical studies or establishing detailed performance metrics against acceptance criteria for novel technologies.

Therefore, I cannot provide the requested information from the provided text. The document clearly states:

• "There are no significant differences between the Great Toe Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."

This indicates that the clearance is based on equivalence, not on the demonstration of specific performance metrics from a new study meeting predefined acceptance criteria.

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