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The Cannulated Metallic Toe Implant, as designed, has the following Indications for Use: Hallux Limitus or Hallux Rigidus, Hallux Valgus, Joint Arthroplasty, Resurfacing of Arthritic M-P Joints.

The material used to manufacture this prosthesis is implant-quality cobalt-chrome alloy ASTM F75. The implant may be cemented to the phalanx or press-fit without cernent.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Cannulated Metallic Hemi Toe Implant." It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls.

Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory approval notice, not a performance study report.

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