(261 days)
The Eztetic™ BellaTek® Encode® Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration.
The Eztetic™ BellaTek® Encode® Healing Abutment is a healing abutment designed to facilitate gingival tissue healing. It consists of an abutment and a retaining screw that are assembled together. Both components are machined from Titanium Alloy (Ti-6AL-4V ELI). The shelf life of the Eztetic™ BellaTek® Encode® Healing Abutment is 5 years and they are intended for single use only. The device is packaged in a sealed nylon bag and sold sterile. The device is sterilized using gamma irradiation method.
This document, a 510(k) summary for the Eztetic™ BellaTek® Encode® Healing Abutments, describes non-clinical testing performed to establish substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria.
Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving the device meets those criteria, as these are typically associated with clinical performance studies, which are not detailed in this document.
However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence:
Non-Clinical Testing Information:
Since this is a non-clinical evaluation for substantial equivalence, the concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone study," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not directly applicable in the way they would be for a clinical efficacy or safety study.
Instead, the document describes tests conducted to ensure the new device is comparable to existing, legally marketed devices.
Here's a breakdown of the non-clinical testing mentioned:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence):
| Non-Clinical Test / Characteristic | Acceptance Criteria (Implied by Equivalence) | Reported Performance (Implied by Conclusion of Substantial Equivalence) |
|---|---|---|
| MR Compatibility | Device is MR conditional (same as previously tested Biomet 3i devices). | The subject devices, having less surface area and volume and made of identical materials as previously tested MR-compatible Biomet 3i devices, are considered MR conditional. |
| Biocompatibility | Biologically compatible (same as primary predicate devices). | The subject devices, made of identical materials and manufactured under identical conditions as primary predicate devices, leverage the predicate's biocompatibility data. |
| Sterilization Efficacy | Minimum Sterility Assurance Level (SAL) of 10⁻⁶; compliance with ISO 11137-1 and ISO 11137-2. | Sterilization validated at 25-38 kGy using gamma irradiation, achieving a SAL of 10⁻⁶, consistent with ISO standards. Quarterly dose audits are conducted. |
| Shelf-Life | Maintain structural integrity and performance for 5 years. | Substantiated 5-year shelf-life based on material stability (Ti-6Al-4V ELI) and successful accelerated/real-time aging studies of packaging. |
| Packaging Integrity | Maintain sterile barrier over labeled shelf life; withstand shipping/vibration conditions without compromise to sterility. | Met acceptance criteria for dye penetration and seal strength after accelerated/real-time aging and shipping/distribution testing (per ISO 11607-1, ASTM D4169). |
| Torque to Failure | Withstand recommended torque (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific values not provided, but passed). |
| Physical Fit Check | Device fits correctly with the mating implant (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed). |
| Tolerance Analysis | Entire tolerance range meets design input (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed). |
| Print Verification | Properly constrained and accurately describes intended original design (similar to primary predicate devices). | Performance demonstrated to be substantially equivalent to predicate devices. (Specific details not provided, but passed). |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated for any of the non-clinical tests.
- Data Provenance: The data is primarily derived from "leveraged" data from previously tested Biomet 3i devices and predicate devices, as well as new bench testing. There is no mention of country of origin as it's non-clinical lab testing. All testing appears to be prospective in the sense that the tests were conducted for this submission, although some rely on retrospective leveraging of prior data.
3. Number of Experts and Qualifications (for Ground Truth):
- This concept is not directly applicable to the non-clinical tests described. The "ground truth" here is adherence to engineering specifications, material properties, and regulatory standards, evaluated by qualified personnel within the company and verified by regulatory bodies.
4. Adjudication Method for Test Set:
- Not applicable as these are non-clinical engineering and material tests, not expert-adjudicated clinical data.
5. MRMC Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images or data. The device in question is a physical dental healing abutment, not an AI diagnostic tool.
6. Standalone Study (Algorithm Only Without Human-in-the-Loop Performance):
- No, a standalone study in this context (algorithm performance) was not done as the device is a physical medical device, not an algorithm or software. The "standalone" performance here refers to the physical and material characteristics themselves, which are addressed by the non-clinical bench testing.
7. Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is based on:
- Regulatory Standards: ISO 11137-1, ISO 11137-2, ISO 11607-1, ASTM D4169, ASTM F 136.
- Engineering Specifications: Design inputs, tolerance ranges, recommended torque values.
- Material Science Properties: Known characteristics of Ti-6Al-4V ELI.
- Prior Validated Test Data: From predicate and previously tested Biomet 3i devices (e.g., for MR compatibility, biocompatibility).
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that would have a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)