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The VALOR™ Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

The design features of the VALOR™ Ankle Fusion Nail System are described below.

• Nails and screws are manufactured from titanium alloy .
• Nails are available in two diameters and a range of lengths .
• Screws are available in one diameter and a range of lengths .

I am sorry, but the provided text from the 510(k) summary (K090857) for the VALOR Ankle Fusion Nail System does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on:

• Device Identification: Proprietary name, common name, regulation number, product code.
• Intended Use: Specifies the medical conditions the device is designed to treat.
• Device Description: Briefly outlines the materials (titanium alloy) and available sizes (two diameters, range of lengths for nails; one diameter, range of lengths for screws).
• Substantial Equivalence: States that the device is substantially equivalent to previously cleared predicate devices in terms of design features, material, and indications for use. It mentions that safety and effectiveness are supported by substantial equivalence information, materials information, and analysis data, but it does not elaborate on what this analysis data entailed or any specific performance criteria.

Therefore, I cannot populate the requested table or answer the questions related to acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided 510(k) summary.

510(k) summaries, like this one, typically aim to demonstrate substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria that would be found in a Premarket Approval (PMA) application or a more extensive clinical trial report. The "analysis data" mentioned is likely mechanical or biocompatibility testing to ensure the device meets basic safety and performance requirements for its intended use, rather than a study against a specific performance benchmark.

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