(74 days)
The NobelProcera Ti 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 Ti 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 Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium or titanium/vanadium alloy.
The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.
The provided text describes a 510(k) premarket notification for a dental implant abutment, not an AI device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from the given text. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing (fatigue testing and analysis of platforms).
Here's an attempt to answer the questions based on the type of information that would be relevant if it were an AI device, but highlighting that this specific document does not contain that information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (N/A): This is a mechanical device, not an AI or diagnostic device with performance metrics like sensitivity, specificity, or accuracy. | N/A: The document states "The testing indicates That the device is safe and effective for its intended use and performs as well or better than the predicate devices." This is a qualitative statement of equivalence, not a quantitative performance result against specific criteria. |
2. Sample size 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: Not applicable. The testing was non-clinical and involved "analysis of platforms to identify worst-case test samples and performance of fatigue testing of the worst-case samples." No patient data or test set in the context of AI or diagnostic performance was used.
- Data Provenance: Not applicable. No patient data or images were used.
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)
- Not applicable. As no patient data or diagnostic interpretations were involved, there was no need for experts to establish ground truth in this context. The "truth" in this case is the mechanical integrity and performance as measured through engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no test set requiring human adjudication as this was non-clinical mechanical testing.
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. This study did not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a physical dental abutment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance was established through engineering standards and physical testing. Specifically, fatigue testing was performed "in accordance with the FDA quidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance document would define the acceptable mechanical properties and performance thresholds.
8. The sample size for the training set
- Not applicable. This device is a manufactured medical component, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.)