(246 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.