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The Straumann Palatal implant is 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 the 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 Straumann Palatal Implant is a modification of the Straumann Ortho Implant. The Palatal Implant is a one piece, threaded self-tapping titanium screw implant with an insertion depth of 4 mm. The design of the Palatal Implant is very similar to the predicate Straumann ortho implants and TE dental implants. The surface of the Palatal implant is the grit blasted, acid etched SLA surface, which is the same as that of the predicate devices. The design of the endosseous part of the palatal implant is the same as the current Straumann TE implants, originally cleared under K012757.

This 510(k) summary (K060062) for the Straumann Palatal Implant does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document is a premarket notification for a medical device seeking substantial equivalence to already legally marketed predicate devices. The basis for substantial equivalence is primarily focused on:

• Intended Use: Identical to the predicate Straumann Orthosystem.
• Material Composition: Same as previously cleared Straumann implants.
• Surface Treatment: Same as predicate devices (grit blasted, acid etched SLA surface).
• Design: Similar to, and in some respects identical to, predicate devices (specifically comparing the endosseous part to Straumann TE implants).

Because this 510(k) relies on substantial equivalence to predicate devices, it typically does not require the submission of new clinical studies with defined acceptance criteria in the same way a Premarket Approval (PMA) application would. The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, ground truth, or MRMC studies based on the provided text, as this information is not present in a 510(k) submission focused on substantial equivalence.

To directly answer your prompt based only on the provided text:

• No acceptance criteria or study demonstrating performance against such criteria are described in this 510(k) summary.
• The document's purpose is to establish substantial equivalence to predicate devices, not to present novel performance data against new acceptance criteria.

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