(54 days)
CLEARFIL MAJESTY ES Flow is indicated for the following restorative applications:
[1] Direct restorations for all cavity classes, cervical lesions (e.g. root surface caries, v-shape defects), tooth wear, and tooth erosion
[2] Cavity base / liner
[3] Correction of tooth position and tooth shape (e.g. diastema closure, tooth malformation)
[4] Intraoral repair of fractured restorations
The subject device, CLEARFIL MAJESTY ES Flow is a light-cure, flowable, radiopaque restorative material which provides accurate color matching, high polishability and excellent physical properties, making it ideal for both anterior and posterior restorations.
It is classified into tooth shade resin material (21 CFR section 872.3690, Product code:EBF) according to 21 CFR8872 since it is composed of materials such as methacrylate monomers.
The provided text describes a 510(k) summary for a dental restorative material, "CLEARFIL MAJESTY ES Flow." It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study for device acceptance criteria in the context of an AI/algorithm-based medical device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable or not provided in this document, as the device is a dental material, not an AI or algorithm.
However, I can extract the information relevant to the material's performance and acceptance based on the provided text, particularly the comparison to the predicate device and compliance with an ISO standard.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ISO 4049:2009 for Effectiveness | The subject device complied with ISO 4049:2009, indicating substantial equivalence in effectiveness to the predicate device. |
| Biocompatibility (Safety) | New ingredients were evaluated referring to ISO 10993 series and ISO 7405 and confirmed to be biologically safe. All other ingredients have established safety through use in predicate devices without reported problems or recalls. |
| Chemical Ingredients Similarity | Except for two new ingredients, all ingredients are the same as predicate devices. The two new ingredients were evaluated for safety. |
| Intended Uses Similarity | The intended uses of the subject device are substantially the same as those of the predicate devices. |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. The study referenced is a comparison to a predicate device and compliance with an ISO standard for material properties, not a clinical study on an AI/algorithm where a "test set" in the context of data points would be relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. This section refers to a dental restorative material, not an AI/algorithm device requiring expert adjudication of ground truth.
4. Adjudication method for the test set
- Not applicable / Not provided. As above, no expert adjudication process is described for this type of material evaluation.
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 restorative material, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical dental material, not an algorithm.
7. The type of ground truth used
- For effectiveness: Compliance with an international standard (ISO 4049:2009).
- For biocompatibility: Evaluation against international standards (ISO 10993 series and ISO 7405) and historical safety data from predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. No "training set" is relevant for this type of material evaluation.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No "training set" or corresponding ground truth establishment is relevant for this type of material evaluation.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.