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The Arthrex AnaToemic™ Phalangeal Prosthesis is a press-fit implant that is intended to be used in patients with hallux limitus, hallux rigidus, hallux valgus, arthritic degradation of the metatarso-phalangeal joint, degenerative arthritis, rheumatoid arthritis, and bunion deformity associated with arthritis of the metatarsal-phalangeal joint.

The Arthrex AnaToemic™ Phalangeal Prosthesis is a one-piece implant system that replaces only half of the affected joint of the metatarso-phalangeal joint of the big toe. It is anatomically designed to provide an optimal fit to the distal articular surface of the affected joint. The implant has two design elements: 1) a polished, concave oval disk; and, 2) a rough stem with a barbed trapezoid shape with a lozenge cross section. On the stem as well as on the distal portion of the disc the surface is rough. The implant material is cobalt chromium alloy (ASTM F1537).

The provided text describes a 510(k) summary for the Arthrex AnaToemic™ Phalangeal Prosthesis. It is a premarket notification for a medical device seeking substantial equivalence to existing predicate devices.

However, the provided text does not contain information regarding detailed acceptance criteria, a specific study that proves device performance against these criteria, or any of the detailed study parameters (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

The text primarily focuses on:

• Device Identification: Manufacturer, contact, trade/common name, product code.
• Predicate Devices: K031859, CAPTM Great Toe Resurfacing Hemi-Arthroplasty; K041595, BioPro Hemi MP Joint.
• Device Description and Intended Use: A one-piece implant for the metatarso-phalangeal joint of the big toe, designed to provide optimal fit, made of cobalt chromium alloy, and intended for conditions like hallux limitus, hallux rigidus, hallux valgus, various forms of arthritis, and bunion deformity associated with arthritis.
• Substantial Equivalence Summary: States that the device is substantially equivalent to predicate devices, with minor design differences that do not raise questions of safety and effectiveness or affect performance, function, or intended use.
• FDA Communication: A letter from the FDA confirming the review of the 510(k) and stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls.

Conclusion:
Based on the provided text, it is not possible to fill out the requested table or provide the detailed study information as the document is a 510(k) summary focused on substantial equivalence rather than a detailed clinical or performance study report. 510(k) submissions often rely on bench testing and comparison to predicate devices rather than extensive new clinical trials with detailed performance metrics against pre-defined acceptance criteria in the manner requested.

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