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The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental supra-structures (false teeth).

The modification is to be able to use stronger titanium because of situations in which this could be beneficial. Since B.A.S.I.C. Dental has been approved as a system using CP Titanium, which is the weakest of the standard titanium available, we would like to be able to use stronger titanium to increase the overall strength of the implant. By using stronger titanium there should be no need for further testing, however the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints.

I'm sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a dental implant modification, focusing on material changes and substantial equivalence to a predicate device. It discusses:

• Device Identification and Modification: B.A.S.I.C. Dental Implant System, modified to use stronger titanium.
• Intended Use: Identical to the predicate device, for replacing missing teeth.
• Comparison to Predicate Device: Argues substantial equivalence based on identical dimensional characteristics and indications for use. Mentions other predicate devices with similar dimensions and titanium alloy materials.
• Testing: States that "the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints."
• Sterilization and Biocompatibility: Confirms the sterilization process remains the same and references ISO standards.
• Conclusion: Reaffirms substantial equivalence.
• FDA Letter and Indications for Use: The official FDA clearance letter and the stated indications for use.

Crucially, it does not provide details about acceptance criteria, specific study designs, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness with human readers (MRMC studies). The mention of "testing revealed... better shear/lateral forces" is too high-level to infer specific acceptance criteria or detailed study methodologies.

Therefore, I cannot populate the requested table or answer the specific questions about the study design, ground truth, or expert involvement based on the provided text.

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