(64 days)
CERA F ALLOY is indicated as a dental alloy for fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.
CERA F ALLOY is a gold-based dental alloy for prosthodontic devices.
This document is a 510(k) premarket notification for a dental alloy, CERA F ALLOY. It is important to note that this is NOT a study report for an AI/ML-based medical device. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, and human-in-the-loop performance is not applicable or cannot be extracted from this document.
However, I can provide the available information:
1. A table of acceptance criteria and the reported device performance
This document does not provide specific acceptance criteria or quantitative performance metrics for CERA F ALLOY in the typical sense of a diagnostic or treatment AI device. Instead, the "performance" is based on its similarity to legally marketed devices and its historical use.
| Acceptance Criteria Type | Reported Device Performance (Summary) |
|---|---|
| Technological Characteristics (Composition) | "All of the components found in CERA F ALLOY have been used in legally marketed devices." |
| Formulation Similarity | "CERA F ALLOY is very similar in formulation to legally marketed dental alloys." |
| Biocompatibility | "This alloy has been on the European market since 2001 with over 250,000 units placed. Therefore, it was determined that no biocompatibility testing was necessary." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study testing a device's diagnostic or predictive performance on a test set. The "performance data" referred to is historical use data.
The data provenance regarding historical use is:
- Country of Origin: Europe
- Retrospective/Prospective: Retrospective (historical use data from 2001 to 2003)
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. Ground truth as typically defined for AI/ML performance evaluation is not relevant to this type of device submission. The "ground truth" for this device's safety and effectiveness relies on the established safety of its component materials and its historical clinical use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set or adjudication process as described for AI/ML performance studies.
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
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental alloy, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or basis for safety and effectiveness) for CERA F ALLOY is established through:
- Historical Use Data/Outcomes Data: "This alloy has been on the European market since 2001 with over 250,000 units placed." This implies that clinical outcomes and safety profiles from this extensive use were considered sufficient to forgo new biocompatibility testing.
- Component Material Precedent: "All of the components found in CERA F ALLOY have been used in legally marketed devices." This refers to the established safety and effectiveness of the individual constituent metals.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. The "training" for this device's regulatory approval stems from the established safety history of its components and the product's historical use. The "sample size" for this historical use is "over 250,000 units placed" in Europe.
9. How the ground truth for the training set was established
Not applicable for an AI/ML "training set." As described above, the "ground truth" for the device's safety and effectiveness was established by:
- The established regulatory history and safety profiles of its constituent materials (components found in legally marketed devices).
- Real-world clinical use data ("over 250,000 units placed" in Europe since 2001) which implicitly includes long-term outcomes and absence of reported adverse events, negating the need for further biocompatibility testing.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.