(80 days)
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healling or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.
The ANKYLOS dental implant system has been previously cleared for commercial distribution. The purpose of this application is to present additional instructions for use sheets for the product. The system and methodology of implantation has not changed with the new labeling.
This 510(k) submission (K040946) for the ANKYLOS® Dental Implant System does not contain a study to prove the device meets acceptance criteria related to performance metrics, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone AI algorithm performance study. This submission is primarily focused on presenting additional instructions for use sheets for a device that has already been cleared (predicate 510(k) K012681).
Therefore, many of the requested elements for describing a study are not applicable to this particular submission. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence to a predicate device, rather than specific performance metrics demonstrated through a new study.
Here's an breakdown based on the provided text, indicating what is present and what is not:
Acceptance Criteria and Device Performance
| Acceptance Criteria (for 510(k) Clearance) | Reported Device Performance (as claimed for Substantial Equivalence) |
|---|---|
| Substantially equivalent in design | The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of design. |
| Substantially equivalent in materials | The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of materials. |
| Substantially equivalent in coatings | The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of coatings. |
| Substantially equivalent in mechanical strength | The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of mechanical strength. |
| Substantially equivalent in prosthetic options | The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of prosthetic options. |
| Substantially equivalent in indications for use | The ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of indications for use. |
| The specific indications are for surgical placement in upper or lower jaw arches, to provide a root form for single or multiple unit prosthetic appliance attachment to restore chewing function. Implants can use 2-stage or single-stage (immediate loading) processes, with immediate loading restricted to the anterior mandible (4 interforaminal placed implants, not single, unsplinted). | |
| No change in system and methodology of implantation | The system and methodology of implantation has not changed with the new labeling. |
| No change in technological characteristics | The technological characteristics of the ANKYLOS® Dental Implant System have not changed with the addition of the new labeling. |
Summary of the "Study" (or basis for clearance):
This submission is a "Special 510(k)" or a similar type where the changes are minimal and do not impact safety or effectiveness. The "study" here is a comparison to a predicate device (Dentsply Ceramco ANKYLOS® Dental Implant System, K012681) to demonstrate substantial equivalence, particularly because the primary purpose of this specific application is to present "additional instructions for use sheets." The manufacturer asserts that design, materials, coatings, mechanical strength, prosthetic options, indications for use, system and methodology of implantation, and technological characteristics have not changed.
Non-Applicable or Not Provided Information from the Text:
Due to the nature of this 510(k) (updates to labeling for an already cleared device), the following information, which would typically be present for a clinical or performance study, is not provided in the given text:
- Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
- Adjudication method for the test set: Not applicable. No test set needing adjudication is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-based device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-based device, and no standalone algorithm performance is mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There's no performance evaluation generating new data that would require a ground truth. The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.
- The sample size for the training set: Not applicable. This is not an AI-based device, and no training set is mentioned.
- How the ground truth for the training set was established: Not applicable. No training set is mentioned.
§ 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.