(134 days)
The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform.
The Zimmer Zfx Titanium Abutment for the Biomet 3i Certain implant system is designed for use with Biomet 3i internal connection implants to support single or multi tooth restorations. The abutment/implant interface is an internal hexagonal connection.
The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.
The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.
The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.
The new abutment will be offered in 3.4mm, 4.1mm, 5.0mm and 6.0mm implant platforms.
The document describes a 510(k) premarket notification for the "Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System." This submission focuses on establishing substantial equivalence to existing predicate devices through non-clinical testing. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table for all features. Instead, it describes compatibility and mechanical fatigue testing. The performance is demonstrated by the results of these tests, which support the claim of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional compatibility with Biomet 3i internal connection implants and retaining screws | Reverse engineering confirmed compatibility. Dimensional specifications were developed for Zimmer Dental components based on reverse engineering results. A tolerance analysis and rotational analysis were conducted to illustrate the nature of fit. |
| Mechanical fatigue strength comparable to predicate device | Fatigue testing was completed using Zimmer Dental fabricated abutments assembled to OEM implants in accordance with FDA guidance. The results were compared to fatigue testing data of Predicate #3 device. (Specific quantitative results not provided in this summary, but the conclusion is that it met the required performance). |
| Sterility Assurance Level (SAL) per sterilization procedures | Sterilization procedures listed in the Instruction For Use were validated to provide a minimum sterility assurance level of 10⁻⁶. |
| MRI safety and compatibility | Evaluated for interactions with magnetic fields during MRI in accordance with FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. (Conclusion implies no additional restrictions beyond those for the patient). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify exact sample sizes for all tests. For "fatigue testing," it mentions "Zimmer Dental fabricated abutments assembled to OEM implants," but the number of samples is not provided.
- Data Provenance: The testing was conducted by Zimmer Dental. The data is from non-clinical laboratory testing performed by the company to support their 510(k) submission. It is prospective in terms of the device being tested, but based on established methods. The country of origin for the data is not explicitly stated but can be inferred to be the USA, given the submission location and company address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: This information is not applicable. The "ground truth" for non-clinical testing is typically based on established engineering standards, material science principles, and FDA guidance documents, rather than expert consensus on a test set in the way it would be for a diagnostic AI device.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not applicable. As this is non-clinical testing of a physical device, there is no "adjudication" in the sense of reconciling expert opinions on observations. The performance is measured against predefined technical standards and predicate device data.
5. 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
- MRMC study: No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often assisted by AI. The device in question is a dental implant abutment, meaning it's a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This device is a physical medical device (an abutment), not an algorithm or AI system. Therefore, standalone performance of an algorithm is not relevant.
7. The type of ground truth used
- Ground Truth: The "ground truth" for this submission relies on:
- Established engineering specifications and measurements: For reverse engineering and dimensional compatibility.
- FDA guidance documents and recognized standards: Such as the "Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments" for mechanical fatigue testing, and "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" for MRI safety.
- Predicate device data: For comparison of fatigue test results.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The device design and manufacturing processes are developed based on engineering principles and knowledge, not through machine learning training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for a physical medical device in this context.
§ 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.)