(310 days)
The Konus K3Pro and K3Pro Rapid Implant is designed for use in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or as a single tooth replacement.
The Konus K3Pro and K3Pro Rapid Implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement.
The K3Pro Konus Dental Implant System include endosseous Rapid and Sure root form and threaded, tapered and straight implants, they come in a range of diameter sizes 3.0 mm to 6.0 mm and range in length from 7.5 mm to 17 mm. Cover screws, healing caps, straight and angled dental implant abutments with threaded abutment connection having a Morse style taper. With a range of 0° to 30 ° angle. Abutment screws, temporary abutments, ball abutments, in a variety of diameters and heights to accommodate differing patient anatomy.
The implants are manufactured from pure, implant-grade 4 titanium. The abutments are manufactured from Grade 5 Ti-6A1 4V-ELI. The internal connection has a 2 mm mini connection with a Konus connection with a 3° taper with a hexagonal orientation. The Standard has a 3 mm Konus connection with a 3° taper with a hexagonal orientation.
Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately.
This is a medical device 510(k) summary for the K3Pro Konus Dental Implant System. It describes the device, its intended use, and how it demonstrates substantial equivalence to predicate devices. However, the document does not contain details about acceptance criteria or a study proving the device meets specific performance criteria in terms of accuracy or clinical effectiveness with regards to AI performance characteristics.
The document states:
- Non-Clinical Testing: "Non-clinical test data was used to substantial equivalence. Non-clinical testing consisted of performance fatigue testing in accordance with the FDA Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801 Dentistry Inplants Dynamic Farigue Test for Endosseous Dental Implants."
- Clinical Testing: "Non-Clinical test data was used of substantial equivalence."
This indicates that no clinical studies for AI performance were conducted or reported in this 510(k) summary. The "acceptance criteria" and "device performance" mentioned in your request, as well as details about sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance, are typically associated with the evaluation of AI/ML-enabled medical devices assessing diagnostic or prognostic performance. This document pertains to a traditional physical dental implant system, not an AI-powered device.
Therefore, I cannot provide the requested information regarding acceptance criteria and AI study details because they are not present in the provided text. The document focuses on establishing substantial equivalence for a physical medical device based on material, design, and non-clinical fatigue testing.
§ 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.