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ANTHOGYR Dental Implant System implant AXIOM is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

AXIOM dental implant system is designed to enhance the functional and aesthetic integration of implant supported restorations. AXIOM implants are made of grade V titanium and present a single connection (2.7 mm) common to all implant forms in the range. AXIOM implants are available in 4 diameters (3.4, 4.0, 4.6 and 5.2 mm) and various heights from 8 to 14 mm. AXIOM dental implant system includes all required prosthetic components and surgical instrumentation.

The provided text details the 510(k) summary for the ANTHOGYR DENTAL IMPLANT SYSTEMS: AXIOM, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than describing a performance study with acceptance criteria for an AI/ML-driven device.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC study, standalone performance, ground truth establishment, and training set details for an AI/ML device) is not present in the provided 510(k) summary.

This document primarily covers:

• Device Description: What the AXIOM implant system is, its materials, sizes, and components.
• Intended Use: The medical conditions and applications for which the device is designed.
• Performance Data (Non-clinical): Mentions fatigue testing, implant-to-abutment compatibility, corrosion testing, and modified surfaces information.
• Clinical Data: Explicitly states "None included."
• Substantial Equivalence: Compares the AXIOM system to its predicate device (PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM - K051614) based on intended use, material, design, mechanical properties, and function.
• Regulatory Information: Product codes, classifications, and panel.
• FDA Communication: The letter from the FDA affirming the substantial equivalence determination and outlining regulatory responsibilities.

Since the device is a dental implant system and not an AI/ML-driven diagnostic or therapeutic tool, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, reader studies, etc.) are not applicable to this document. The "performance data" referred to here are engineering and material performance tests, not clinical performance or AI algorithm performance.

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