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The Arthrex ProStop™ Plus Arthroereisis Subtalar Implants are indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.

The Arthrex ProStop™ Plus Arthroereisis Subtalar Implant is a fully threaded, cannulated, tapered screw. It is similar in design to the predicate device MBA Resorb Implant, K051611.

This document is a 510(k) summary for the Arthrex ProStop Plus Arthroereisis Subtalar Implant. It describes the device and its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or details about standalone performance or training sets. This is typical for a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting detailed clinical study results and acceptance criteria in the manner requested.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. The document primarily focuses on regulatory approval based on demonstrating equivalence rather than a detailed performance study against specific acceptance criteria.

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