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The Lorenz Orthodontic Anchorage System implants are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.

The Walter Lorenz Surgical Orthodontic Anchorage System is comprised of a variety of plates and screws designed to provide anchorage for orthodontic procedures.

The provided text is a 510(k) summary for the Lorenz Orthodontic Anchorage System. It describes the device, its intended use, materials, and substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about studies, sample sizes, ground truth, or expert involvement, as that data is not present in the provided submission.

The document essentially states that the device is substantially equivalent to previously cleared devices based on its application and function. This type of submission (510(k)) typically relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and performance metrics like those for a PMA submission or some de novo classifications.

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