(185 days)
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the maxilla and/or mandible and splinted in the anterior region, immediate loading is indicated.
The NanoTite Dental Implants, hereinafter referred to as NanoTite Dental Implants, are the same dental implants referred to as "3i Nano CaP OSSEOTITE" Dental Implants, subject of the predict device submission K051461. The NanoTite Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface further treated with a deposition of nanometer scale crystals of calcium phosphate. Implants are offered in both tapered and parallel-walled/straight designs, and each design provides offerings for either external hex or internal connections.
This document is a 510(k) Premarket Notification for the NanoTite™ Dental Implants. It seeks to demonstrate substantial equivalence to previously cleared predicate devices (K051461). The nature of this submission is not for an AI/ML device, therefore the requested information regarding acceptance criteria, study data, and ground truth for an AI/ML device is not applicable.
The document describes a medical device (dental implants) and its intended use, and it relies on established engineering and materials performance testing rather than clinical study of an AI algorithm.
Here's an explanation of why the requested AI/ML specific information cannot be extracted from this document:
- No AI/ML Component: The submission describes a physical medical device (dental implants) that is treated with a specific surface technology (nanometer scale crystals of calcium phosphate). There is no mention of any artificial intelligence, machine learning, or software algorithm that provides diagnostics, prognostics, or treatment recommendations.
- Performance Testing for Physical Device: The "Performance Testing" section states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971. Results from all of these tests were included in the premarket notification submission for the predicate devices, K051461." This indicates that the performance data refers to physical and biological compatibility testing of the implant itself, not the performance of an AI algorithm.
- Substantial Equivalence: The primary goal of this 510(k) is to demonstrate substantial equivalence to the predicate device (3i OSSEOTITE Dental Implants, K051461). This involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This is a common regulatory pathway for non-AI/ML devices.
Therefore, the questions regarding acceptance criteria, study details, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for an AI/ML device are not applicable to this 510(k) submission.
§ 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.