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The ANKYLOS® Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseus implant.

The ANKYLOS® Dental Implant System has been cleared for commercial distribution. The purpose of this application is to obtain clearance for additional marketing claims associated with the special features of the ANKYLOS® Dental Implant System.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for the ANKYLOS® Dental Implant System. It primarily focuses on:

• Device Description and Intended Use: Explaining what the device is and what it's used for.
• Predicate Device Information: Stating that the current device is substantially equivalent to a previously cleared one.
• Technological Characteristics: Asserting that no changes have been made to the device itself, implying that previous safety and effectiveness data still apply.
• Regulatory Communication: Correspondence from the FDA affirming the substantial equivalence and permitting marketing.

There is no mention of:

• Specific performance metrics or acceptance criteria for the device (e.g., success rates, torque values, osseointegration rates).
• Any clinical or non-clinical study that was conducted to demonstrate performance against such criteria.
• Details about test sets, data provenance, expert panels, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot provide the requested table or detailed information about a study based on the given text.

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