(31 days)
Ceramir Crown & Bridge is intended for the permanent cementation of
- Porcelain Fused to Metal Crowns and Bridges .
- Metal (gold etc.) crowns and bridges .
- . Gold inlays and onlays
- . Cast or prefabricated metal posts
- . Strengthened core all-zirconia or all-alumina ceramic crowns and bridges
Ceramir Crown & Bridge is a hybrid glass ionomer-ceramic dental cement. The liquid and powder are packed are in a capsule format. The capsule is activated and the powder and liquid is mixed in a mixer before use.
The provided text does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way typically found for AI/ML devices.
Instead, this document is a 510(k) summary for a dental cement called Ceramir® Crown & Bridge. The core of its approval is based on demonstrating substantial equivalence to a predicate device, XeraCem™.
Here's a breakdown of why the requested information cannot be fully provided based on the input:
- Device Type: The device described is a dental cement, not an AI/ML diagnostic or measurement device. Therefore, the concepts of "test set," "ground truth," "experts," "adjudication," "MRMC studies," or "standalone performance" as they relate to AI/ML devices are not applicable here.
- Performance Data Basis: The approval hinges on the new device being "technologically identical" to its predicate device (XeraCem™) in terms of powder and liquid composition and the proportion of these components in the mixed cement. The differences are in packaging and mixing format (capsule vs. hand-mixed).
- "Studies have proven the properties...to be substantially equivalent": This is a general statement. The document does not detail specific studies, their methodology, sample sizes, or acceptance criteria in the context of quantitative performance metrics for AI/ML. It refers generally to "properties, including biocompatibility."
Therefore, I cannot populate the table or answer most of your specific questions as they relate to the performance evaluation of an AI-based system.
However, I can provide the following based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (XeraCem™) | Ceramir® Crown & Bridge is "technologically identical" to its predicate device, XeraCem™. |
| The powder and liquid are identical. | |
| The proportion between amount of powder and amount of liquid is the same. | |
| "Studies have proven the properties, including biocompatibility of the cement to be substantially equivalent to the predicate device." | |
| Same Intended Use as Predicate Device | Ceramir® Crown & Bridge has the same intended use as its predicate device. |
| Safe and Effective as Predicate Device | Ceramir® Crown & Bridge is "as safe and effective as the predicate device and performs as well as the predicate device." |
Explanation: For this type of device (a dental cement), the "acceptance criteria" for regulatory clearance are primarily demonstrating substantial equivalence to a previously cleared product. This means showing that the new device is as safe and effective as the predicate device for its indicated uses, and that any technological differences do not raise new questions of safety or effectiveness. The reported performance is that it meets this standard by being "technologically identical" in crucial aspects and having "substantially equivalent" properties.
The other points are not applicable or cannot be answered from the provided text for this specific device.
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 information is not provided because the approval is based on substantial equivalence to a predicate device, not on specific performance metrics derived from a "test set" in the context of an AI/ML algorithm.
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: There is no "ground truth" establishment in the context of expert review for an AI/ML algorithm for this dental cement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No test set or expert adjudication process for an AI/ML algorithm is described.
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 is a physical dental cement, 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 is a physical dental cement, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable: There is no "ground truth" as typically understood for AI/ML devices. The "truth" for this device's performance is established by demonstrating its material properties are equivalent to the predicate device.
8. The sample size for the training set
- Not Applicable: This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable: This device is not an AI/ML algorithm that requires a training set or ground truth establishment in that context.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.