(88 days)
For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.
Unfortunately, the provided text does not contain the specific information requested regarding acceptance criteria, study details, and performance metrics for a medical device.
The document appears to be a 510(k) summary for a "5.0mm Spline Endosseous Dental Implant System" by Calcitek, Inc. This type of document is typically submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
The content focuses on:
- Identification of the device and company.
- Intended Use: Stating that the intended use is identical to a predicate device.
- Description: Noting it's a Class III dental implant, supplied sterile, and ready for placement.
- Technological Characteristics: Highlighting that design and materials are unchanged from previously cleared devices.
- Comparison Analysis: Emphasizing that the overall design is identical to predicate devices and that the 5.0mm size is a "scaled up" version. It makes a qualitative statement about expected mechanical strength ("will be stronger") due to increased cross-section and identical materials, rather than providing quantitative performance data or acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text.
This document is more about establishing substantial equivalence based on design, material, and intended use similarity to pre-existing, cleared devices rather than providing a detailed performance study against specific acceptance criteria.
§ 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.