(51 days)
The Hero II Dental Implant System and the UI Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
The Hero II Dental Implant System and the UI Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments.
The provided text describes a Special 510(k) submission (K130221) for the "Hero II Dental Implant System" and a renamed "UI Dental Implant System." This submission aims to add a new design fixture model and change a name, stating that the intended use and principal technology are unchanged from the unmodified device (K121047).
The document does not contain acceptance criteria or a study proving that the device meets those criteria, as typically understood for performance metrics like sensitivity, specificity, or reader agreement in AI/imaging devices. Instead, this 510(k) is a substantial equivalence determination based on comparison to a predicate device.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not define specific performance acceptance criteria (e.g., accuracy, precision) for the dental implant system itself, nor does it report performance metrics against such criteria in the context of a clinical study or statistical analysis. The "performance" mentioned refers to the device's characteristics and materials.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No "test set" in the context of evaluating performance metrics (like for an AI or diagnostic device) is mentioned. The submission is based on non-clinical testing and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No "ground truth" establishment by experts for a test set is described.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention any MRMC study or any study comparing human readers with and without AI assistance. This device is a dental implant, not a diagnostic imaging device with an AI component in the described context.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical medical device (dental implant), not an algorithm or AI system.
7. Type of Ground Truth Used
Not applicable. There is no mention of ground truth in the context of pathology, outcomes data, or expert consensus for assessing device performance. The "ground truth" in this submission relates to the device's physical and material characteristics being substantially equivalent to the predicate.
8. Sample Size for the Training Set
Not applicable. The device is a physical dental implant, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device Acceptance and Study (Based on the Provided Text):
The acceptance of the "Hero II Dental Implant System" and "UI Dental Implant System" in this 510(k) submission is based on demonstrating substantial equivalence to a previously cleared predicate device (K121047). The study that proves this is a comparison of the subject device's characteristics to those of the predicate device, supported by non-clinical testing.
Acceptance Criteria (Implicitly based on Substantial Equivalence):
- Intended Use: Must be the same as the predicate device.
- Technological Characteristics: Must be the same or similar to the predicate device, with any differences not raising new questions of safety or effectiveness.
- Material Composition: Must be the same as the predicate device (Titanium 6AL 4V ELI alloy).
- Performance Characteristics (Non-Clinical): Must meet the same non-clinical performance standards as the predicate device (e.g., cleanness after surface treatment, shelf-life, sterilization validation).
Study Proving Acceptance (Substantial Equivalence Determination):
- Purpose of Submission: To add a new design fixture model and change a name to an unmodified device cleared under K121047. The intended use and principal technology of the subject device are stated to be the same as the unmodified device.
- Device Description: The subject devices (Hero II and UI Dental Implant System) are dental implant systems made of Titanium 6AL 4V ELI alloy. Their surfaces are treated with R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments. Size information for various diameters and lengths is provided.
- Indications for Use: The indications for use are identical to those of the predicate device, covering use in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations, and intended for single and two-stage surgical procedures with delayed loading.
- Non-clinical testing:
- Tests Conducted: Energy Disperse X-ray micro analyzer (EDX) and Scanning Electron Microscopy (SEM) Analysis to verify cleanness after surface treatment, shelf-life testing, and sterilization validation.
- Rationale: These tests were conducted on the unmodified device (K121047) and reviewed in that previous 510(k) submission. The document states that "These characteristics have not been changed on the modified device; therefore it is substantially equivalent to the unmodified device in these regards."
- Basis for Substantial Equivalence:
- Same intended use as predicate (K121047).
- Same fundamental scientific technology: threaded, root form implants made of titanium.
- Same internal hexagon abutment connection system with internal beveled interface.
- Both are bone-level implants with similar body shape design (straight walled neck and tapered body design).
- Difference: "minor thread design on the fixture." The submission implicitly argues this minor difference does not raise new questions of safety or effectiveness.
- Conclusion: The submission concludes that the subject devices are substantially equivalent to the predicate devices based on identical intended use, operating principle, basic design, and material.
In essence, the "study" is a technical and regulatory comparison against a predicate device, demonstrating that the new/modified dental implant systems do not introduce new safety or effectiveness concerns compared to already cleared devices.
§ 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.