(105 days)
Implant:
The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and lateral incisors of the lower jaw.
VARIOunite PF 3.0:
Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
VARIOunite:
Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium. It is provided in two surfaces (TST and INICELL) and five lengths (8.0, 9.5, 11.0, 12.5, and 14 mm). Subject device components available for the ELEMENT Ø 3.0 implant are the healing cap, gingiva former and VARIOunite abutments. VARIOunite abutments can be used for temporary restorations, permanent restorations, or CAD/CAM zirconia superstructures. The indications for previously cleared VARIQunite abutments have been expanded to include angulation of the CAD/CAM zirconia superstructures.
This document describes a 510(k) premarket notification for the Thommen Implant System, specifically focusing on the ELEMENT PF 3.0 dental implant and VARIOunite abutments.
Here's an analysis of the acceptance criteria and the study used to demonstrate equivalence, based on the provided text:
No specific acceptance criteria in terms of performance metrics (e.g., success rates, survival rates, specific mechanical thresholds for clinical outcomes) are explicitly stated in this document for the device. The submission focuses on demonstrating substantial equivalence to predicate devices. This means the device is considered safe and effective because it is as safe and effective as a legally marketed device (predicate device).
The "study" or rather, the evidence provided, primarily consists of non-clinical testing data and comparisons to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
As stated above, no explicit quantitative acceptance criteria or corresponding clinical performance metrics are provided in the document. The general "acceptance criteria" for a 510(k) submission are that the new device is "substantially equivalent" to predicate devices in terms of intended use, technological characteristics, and materials, and that any differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance/Evidence |
|---|---|
| Intended Use Equivalence | The device (ELEMENT PF 3.0 implant, VARIOunite PF 3.0, VARIOunite) has substantially equivalent indications for use as the listed predicate devices (K093615, K160244, K102804, K151984, K121334, K120414). Minor language differences do not change the intended use. |
| Technological Characteristics Equivalence | Similar design principles (self-tapping, root form, internal connection for implant; straight/angled for abutments), materials (CP Titanium, Titanium Alloy), and physical dimensions (diameter, length) to predicate devices were demonstrated through comparison tables. |
| Material Equivalence | Device materials (CP Titanium for implant, CP Titanium/Titanium Alloy for abutment, Titanium Alloy for screw) are the same or similar to those used in predicate devices. |
| Mechanical Performance | Mechanical testing according to ISO 14801 was performed to ensure the device is strong enough for its intended use. (Specific values or pass/fail criteria are not provided in this document). |
| Sterilization Validation | Radiation sterilization validation (ISO 11137-1, ISO 11137-2) and Steam sterilization validation (ISO 17665-1, ISO 17665-2) were performed. |
| Biocompatibility | Biocompatibility evaluation according to ISO 10993-1, by reference to predicate device submissions (K093615, K160244, K102804, K121334). |
| Endotoxin Testing | Limulus amebocyte lysate (LAL) endotoxin testing in accordance with FDA Guidance. |
| Shelf Life & Packaging | Testing for seal leaks (ASTM F88/F88M), seal strength (ASTM F1886/1886M), seal integrity (ASTM F1929), dye penetration (ASTM F3039), and packaging (ISO 11607-1, ISO 11607-2). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical trials. For non-clinical testing (mechanical, sterilization, etc.), specific sample sizes are not detailed in this summary. These tests typically involve a pre-defined number of units/samples for each test type according to the relevant standard.
- Data Provenance: The data is non-clinical, originating from laboratory testing conducted to international (ISO, ASTM) and FDA guidance standards. The manufacturer is Thommen Medical AG, Switzerland. The data is not derived from human subjects or patient populations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This is not applicable as the submission did not include clinical data or studies requiring expert review of patient cases to establish ground truth.
4. Adjudication Method for the Test Set
- This is not applicable as the submission did not include clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical data were included in this submission." This type of study is typically used for diagnostic or imaging devices, not for dental implants which rely on mechanical and biological performance demonstrated through non-clinical testing and clinical experience with similar devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- This is not applicable. The device is a physical dental implant system, not a software algorithm.
7. The Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable limits set by recognized international standards (ISO, ASTM) and FDA guidance documents for each specific test (e.g., sterilization effectiveness, material strength, biocompatibility, packaging integrity).
8. The Sample Size for the Training Set
- This is not applicable. There is no software algorithm or AI model being trained for this device.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as there is no software algorithm or AI model being trained for this device.
§ 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.