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For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.

Unfortunately, the provided text does not contain the specific information requested regarding acceptance criteria, study details, and performance metrics for a medical device.

The document appears to be a 510(k) summary for a "5.0mm Spline Endosseous Dental Implant System" by Calcitek, Inc. This type of document is typically submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The content focuses on:

• Identification of the device and company.
• Intended Use: Stating that the intended use is identical to a predicate device.
• Description: Noting it's a Class III dental implant, supplied sterile, and ready for placement.
• Technological Characteristics: Highlighting that design and materials are unchanged from previously cleared devices.
• Comparison Analysis: Emphasizing that the overall design is identical to predicate devices and that the 5.0mm size is a "scaled up" version. It makes a qualitative statement about expected mechanical strength ("will be stronger") due to increased cross-section and identical materials, rather than providing quantitative performance data or acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text.

This document is more about establishing substantial equivalence based on design, material, and intended use similarity to pre-existing, cleared devices rather than providing a detailed performance study against specific acceptance criteria.

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