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The Aarhus Anchorage System is intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.

The Aarhus Anchorage System consists of 9.6 mm to 12.2 mm in length, non-sterile, single-use titanium screws designed to aid in dental movement by providing a rigid skeletal fixation point. The "self-drilling" thread design allows for easy insertion and removal - with the use of the system`s Grip Screwdriver Replaceable F Aarhus Screw Octagonal and Blades.

This is a 510(k) summary for the Aarhus Anchorage System. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process does not typically involve detailed clinical studies with acceptance criteria as would be found in a PMA. Instead, it relies on demonstrating equivalence to existing devices.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, or clinical performance data against specific metrics.

The document focuses on:

• Device Description: The Aarhus Anchorage System consists of non-sterile, single-use titanium screws (9.6 mm to 12.2 mm long) designed to aid in dental movement by providing a rigid skeletal fixation point.
• Intended Use: To serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after treatment.
• Substantial Equivalence Claim: The device claims substantial equivalence to:
  • Medicon eG, Micro Titanium Plate System (for material)
  • KLS Martin L.P., Ortho Anchorage System (for application and function)

In summary, a 510(k) notification does not typically present a study with acceptance criteria in the manner you've outlined. The FDA's determination of "substantial equivalence" is the primary "acceptance criterion" for a 510(k) device.

If this were a different type of submission (e.g., a PMA, or a more recent 510(k) for a novel device that requires performance data), then the detailed study information would be present. Based only on the provided text, I cannot answer the specific points about acceptance criteria and study details.

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