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The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.

The Ortho implant is a solid, one-piece, threaded, self-tapping design made from CP Grade 4 titanium. It has a sand-blasted, acid etched (SLA) rough surface on the endossous portion of the implant. The transmucosal section of the implant has a smooth machined surface to allow for the attachment of epithelial tissue. The coronal portion of the implant is internally threaded and has a hex head.

The provided text describes a 510(k) summary for the Straumann Ortho implant. However, it does not contain information about acceptance criteria for device performance or a study proving that the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a previously marketed predicate device (Straumann Ortho System K982509). The rationale for substantial equivalence is explicitly stated as:

"The subject Straumann Ortho implants have the same design as the previously cleared Straumann Ortho implants. There has been no change in material, surface treatment, design, or operating principle."

This suggests that the new device is considered equivalent because it is identical to a device already deemed safe and effective, rather than a new study with performance acceptance criteria being conducted.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document. The 510(k) process in this instance relies on equivalence, not on new performance data against specific acceptance criteria.

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