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The Osstell Mentor is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region. The Osstell Mentor can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the surgeon.

The Osstell Mentor Resonance Frequency Analyzer (RFA) is an updated version of the Osstell™ (K003714), the system designed to measure dental implant stability in the oral cavity and craniofacial region. Similar to K003714, the Osstell Mentor is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The updated system involves the use of a Smartpeg (aluminum rod) attached to the dental implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement probe on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the stability of the implant and is derived from the resonance frequency value obtained from the Smartpeg.

The provided text is a 510(k) summary for the Osstell Mentor RFA device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The document's purpose is to demonstrate substantial equivalence to a previously cleared device (Osstell, K003714), not to present performance data against specific acceptance criteria for a new clinical study. The basis for substantial equivalence is primarily described as:

• Same indication for use.
• Similar functioning, both using vibration to assess implant stability.
• No unique or new applications, indications, or functions.
• Raises no new issues with respect to safety or effectiveness.

Therefore, I cannot populate the requested table or answer most of your detailed questions because the information is not present in the provided text.

In summary, the document does not contain the information needed to answer your request about acceptance criteria and a study proving the device meets them.

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