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The Ortho Anchor Screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

The MIS Ortho Anchor Screws are self-tapping screws that are used as fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. The screw is manufactured as one piece screw made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The upper head of the screw has a cross-hole through which a wire can pass to fix the mandible and maxilla in the orthodontic procedure. The screw head is special designed to assist the use of orthodontic appliances. The Ortho Anchor Screws are provided in several lengths ranging between 5-10mm and diameters of 1.4mm, 1.6mm and 2mm. The screws are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are supplied sterile.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics.

The document is a 510(k) summary for Ortho Anchor Screws, which primarily focuses on demonstrating substantial equivalence to a predicate device. This type of submission relies on showing that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria.

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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