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The Ortho-Pro STS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions:

• Severely pronated foot
• Walking intemperance
• Calcaneal stance position greater than 5°
• Manually correctable deformities
• Mid-tarsal breech (arch pain)
• Forefoot varus greater than 10°

The Ortho-Pro STS Screw consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. External rounded threads increase ease of insertion. This device is manufactured from Ti-6A1-4V alloy and is available in six sizes, 06.5mm to Ø11.5mm in 1mm increments.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

The document is a 510(k) summary for the Ortho-Pro STS Screw, a bone screw. It describes the device, its intended use, and its technological characteristics compared to a predicate device. It also includes the FDA's clearance letter for the device.

Therefore, I cannot provide the requested table and information as it is not present in the given input.

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