(146 days)
The NobelProcera Zi Abutments Thommen Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.
Nobel Biocare's NobelProcera Zi Abutment Thommen Platforms is an endosseous dental implant abutment. The abutment attaches directly to Thommen dental implants and provides a platform for restoration.
Nobel Biocare's NobelProcera Zi Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide.
The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.
The NobelProcera Zi Abutment Thommen Platforms device did not undergo clinical testing and therefore does not have traditional acceptance criteria based on performance metrics like sensitivity or specificity. Instead, the testing focused on validating the device's mechanical integrity and substantial equivalence to existing predicate devices.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Integrity: Withstand fatigue testing in accordance with FDA guidance for Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. | Fatigue testing was performed on "worst-case samples" and supported the decision of safety and effectiveness, implying the device met the criteria. |
| Substantial Equivalence: Demonstrate equivalence in design, anatomical site, platform compatibility, and indications for use compared to legally marketed predicate devices. | The submission concluded that the device is substantially equivalent to the predicate devices (NobelProcera Ti Abutment Thommen Platforms (K101714), Thommen Medical AG - SPI Easy 4.0 Abutment (K071457), and Thommen Medical AG - SPI Dental Implant Abutments (K031747)). |
| Biocompatibility: Utilize zirconium oxide, a material considered acceptable for medical devices. | The device is made entirely of zirconium oxide, implying its biocompatibility is assumed to be equivalent or acceptable based on material properties. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "worst-case test samples" for fatigue testing. The exact number of samples is not specified.
- Data Provenance: The testing was "non-clinical test data," indicating laboratory or engineering testing. The country of origin and whether it was retrospective or prospective is not specified, though it would typically be conducted by the manufacturer in a controlled lab setting (prospective in that context).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This device did not involve human interpretation or diagnostic assessment. Therefore, there were no experts used to establish ground truth in the traditional sense of medical image analysis or clinical outcomes. The "ground truth" for mechanical testing would be the engineering specifications and performance expectations outlined in the FDA guidance document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Since the testing was non-clinical and focused on mechanical performance, there was no adjudication method involving human experts for a test set. The evaluation would have been based on established engineering and materials science principles.
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
- No MRMC comparative effectiveness study was done. This device is a dental implant abutment, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical dental implant component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" was based on engineering specifications and performance requirements as outlined in the FDA guidance document: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance provides the standards for fatigue and other mechanical tests.
8. The sample size for the training set
- This question is not applicable as the device is a physical medical device and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- This question is not applicable as there was no training set for this device.
§ 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.)