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This looks like a summary of a 510(k) submission for a medical device called "Dentatus MTI™ Anchor Post," which is an endodontic splint.

However, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. The document focuses on:

• Classification and identification of the device.
• A brief literature review asserting the safety and effectiveness of endodontic splints in general, not specifically the Dentatus MTI™ Anchor Post through a dedicated study.
• Substantial equivalence claims to pre-amendment devices and previously cleared devices, which is a regulatory pathway that often bypasses the need for new, extensive clinical studies if a device is sufficiently similar to existing ones.
• Technology details confirming it uses established materials and manufacturing methods.

Therefore, I cannot populate the table or answer your specific questions with the information provided. The document explicitly states: "Endodontic splints made of titanium or titanium alloy have V. been proved safe and effective through the years," implying reliance on general historical use and existing literature rather than a new study for this specific device.

If you have a different document that details acceptance criteria and performance studies for the Dentatus MTI™ Anchor Post, please provide that.

Ask a specific question about this device