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The ORLUS Mini Screw is intended for use as a temporary anchor for orthodontic treatment.

ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.4 - 1.8 mm in diameter and range from 5-13 mm 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 dental device. It declares substantial equivalence to a predicate device and outlines the device's characteristics and intended use.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets specific acceptance criteria. It is a regulatory submission for premarket notification, not a clinical or performance study report.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set, data provenance, or details on training sets.
• Information on experts, ground truth establishment, or adjudication methods for any test data.
• Details about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

The document states, "ORLUS mini screw has been subjected to product validations prior to release," but it does not provide any specifics of these validations, their methodologies, or their results in relation to performance criteria.

Therefore,Based on the provided text, I cannot describe the acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) summary and does not contain the detailed performance study information requested.

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