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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 1.6 and 1.8 mm in diameter and range from 5-14mm in total length and is made of Titanium 6Al-4V alloy. There are dual heads in the screw with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.

The provided document is a 510(k) summary for the ORLUS mini screw, a temporary anchor for orthodontic treatment. It states that the device has undergone "extensive safety, performance, and product validations prior to release" and that "Safety tests have been performed to ensure the devices comply to applicable industry and US regulations." It also mentions an "extensive review of literature pertaining to the safety and biocompatibility of ORLUS mini screw has been conducted" and that "Appropriate safeguards have been incorporated in the design of ORLUS mini screw."

However, the document does not contain specific acceptance criteria or detailed results of a study that proves the device meets such criteria. It relies on substantial equivalence to predicate devices (Osterned Orthodontic Screw System, OsteoMed L.P., K031936 and Dual Top Anchor System Screws, Jeil Medical Corporation, K033767) based on material, design, and use concept being similar.

Therefore, I cannot populate the table or answer the specific questions below as the information is not present in the provided document. The document describes a regulatory submission pathway focused on equivalence rather than detailed performance study results against predefined acceptance criteria.

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