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510(k) Data Aggregation
(29 days)
Ducera® AllCeram is an all-ceramic system for veneering of aluminum oxide cores or tooth preparations.
Ducera® AllCeram is indicated for veneering of aluminum oxide cores or tooth preparations.
Ducera® AllCeram is an all-ceramic system for veneering of aluminum oxide cores or tooth preparations.
The provided document is a 510(k) summary for a dental product, Ducera® AllCeram. It does not contain information about a study that assesses device performance against acceptance criteria in the way typically expected for medical imaging AI or diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on material composition and prior use of components.
Therefore, many of the requested sections about study design, sample sizes, expert involvement, and ground truth establishment are not applicable.
Here's the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or performance metrics for the Ducera® AllCeram. The basis for acceptance is rooted in its "nearly equivalent material composition" and "similarity in the formulations" to the predicate device, VITADUR® ALPHA Porcelain (K921623).
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Material composition and formulation similar to legally marketed predicate devices. | "Nearly equivalent material composition of Ducera® AllCeram to the predicate device" and "similarity in the formulations to those legally marketed devices." |
| Components previously used in legally marketed devices. | "All of the components found in Ducera® AllCeram have been used in legally marketed devices." |
| Safety and effectiveness for the intended use (veneering of aluminum oxide cores or tooth preparations). | Supported by the "prior use of the components in legally marketed devices, the similarity in the formulations to those legally marketed devices, and the performance data provided." (Note: "performance data provided" is not detailed in this summary). |
2. Sample Psize used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a material substantial equivalence submission, not a performance study involving a test set of data/images.
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 for a test set is not relevant to this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 a dental material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" used for this submission is the established safety and effectiveness of the predicate device's material composition and components.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this material evaluation.
9. How the ground truth for the training set was established
Not applicable.
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