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Osteoarthritis. Where the use of a more conservative procedure has failed or is unacceptable. The device is intended for non-cemented use.

The Signal Medical Corporation Great Toe Implants are manufactured from ASTM F75 Cobalt Chrome. The porus coating is ASTM F75 sintered beads, -45+60 mesh. The device is intended for non-cemented use. The stem of the device is intended to be inserted into the proximal end or base of the first phalangel bone. The convex surface of the implant is intended to articulate with the distal end or head of the first metatarsal bone. The design is made available in multiple sizes equivalent to the toe implants in the Townley Great Toe Joint 510K (K911378) and the Zimmer Great Toe 510K (K823405).

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets them.

The document is a 510(k) summary and an FDA clearance letter for the Signal Medical Corporation Great Toe Implants. It focuses on:

• Device Description: What the device is made of and its general function.
• Intended Use/Indications for Use: What the device is for (osteoarthritis, when conservative procedures fail).
• Substantial Equivalence: The FDA's determination that this device is substantially equivalent to previously marketed predicate devices (Townley Great Toe Joint 510K (K911378) and Zimmer Great Toe 510K (K823405)). This is the core of a 510(k) submission, confirming that a new device is as safe and effective as a legally marketed one without requiring new clinical trials or extensive performance testing if the predicate device itself didn't necessitate them.
• Regulatory Information: FDA regulations, general controls, and contact information.

This type of submission typically relies on comparison to predicate devices, material testing, and sometimes bench testing, rather than extensive clinical studies with specified acceptance criteria as would be found in a Premarket Approval (PMA) application or a more complex medical device.

Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this information is not present in the given text.

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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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