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The ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.

ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.41.8mm in diameter and ranges from 513mm in total length. It is made of Titanium 6Al-4V alloy. There is a hole in the screw head with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.

This 510(k) summary for K082838 does not contain the results of a study with specific acceptance criteria and device performance metrics. Instead, it demonstrates substantial equivalence to predicate devices (K050568, K052968, and K033767) based on similarities in device characteristics, material, design, and intended use.

Therefore, I cannot provide the requested information in the format of acceptance criteria and reported device performance, sample size, data provenance, expert information, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information.

The document explicitly states: "ORLUS Mini Screw has the same device characteristics, material, design and intended use as the predicate device." and concludes that it is "safe and effective and substantially equivalent to the predicate device as described herein." This indicates a comparison to existing devices rather than a new performance study with quantified acceptance criteria.

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