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Temporary anchorage point for the attachment of orthodontic appliances

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The provided document is an FDA 510(k) clearance letter for the Infinitas Mini-Implant System. It does not contain information about acceptance criteria for a device's performance, nor does it describe any study that proves a device meets such criteria.

The document primarily focuses on:

• Stating that the device is substantially equivalent to legally marketed predicate devices.
• Listing the regulation number, name, and product code.
• Outlining the general controls and additional controls that may apply.
• Providing contact information for regulatory guidance.
• Stating the intended use of the device ("Temporary anchorage point for the attachment of orthodontic appliances").

Therefore, I cannot answer your request as the information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies is not present in the provided text.

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