(64 days)
Implant systems are for use in single tooth, partially edentulous, completely edentulous, mandibles and maxillae as a support or attachment for prosthetic restoration. The restoration can be detachable (screw relained) prosthetics in multiple, free standing or terminal restorations.
The conical abutment is designed for use with an endosseous implant which is implanted in the lower or upper jaw. The conical abutment provides a base for the restorative crown or bridgework.
The provided text is a 510(k) Summary for a medical device called "Lifecore Conical Abutment." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and study results for device performance in the way a clinical study report would.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document, as it is not present. The summary states:
- "The technological characteristics of the modified version of the conical abutment and the earlier versions are identical. The titanium used in both devices is the same. Manufacturing processes are also the same as is general shape and structure. Therefore, no new types of technology and no new technological questions are involved."
This statement indicates that the submission is based on the premise that the new device is essentially the same as a previously cleared version, and thus does not require new performance studies with specific acceptance criteria that would typically be detailed in a clinical trial report.
To provide the requested information, a document describing a de novo approval process or a clinical study for a novel device would be necessary.
§ 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.