(82 days)
Amaris® Gingiva Opaquer is intended for use in conjunction with Amaris Gingiva for the following applications:
- for the aesthetic covering and masking of discoloured hypersensitive necks of teeth, especially in the visible anterior area.
- for corrections of the red-white aesthetics.
- for masking and lightening of crown and bridge restorations and margins.
Amaris® gingival shade is a light-curing radiopaque restorative which contains 80% fillers in a methacrylate matrix and which can be cured with blue light. Amaris® gingival shade is used to treat cervical defects and exposed, discoloured or hypersensitive necks of teeth, especially in the visible anterior area. The gingival-like shade and the Amaris® Gingiva Opaquer system allow the correct reproduction of the gingiva in its shade.
The provided text is a 510(k) summary for the medical device "Amaris® Gingiva Opaquer," which is a dental material. This document is a regulatory submission to the FDA, and it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way a diagnostic or therapeutic device might.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory document. The "study" here refers to the rationale for substantial equivalence based on material composition and prior use, not a clinical performance study with statistical endpoints.
Here's an analysis based on the information available in the document:
Analysis of Acceptance Criteria and Device Performance for Amaris® Gingiva Opaquer
This submission primarily demonstrates substantial equivalence for a dental material (Amaris® Gingiva Opaquer) to a previously marketed predicate device (Clearfil ST Opaquer/Kuraray Co. Ltd., K001913). The "acceptance criteria" are implicitly met by demonstrating that the device is of similar technological characteristics and intended use as the predicate, thus implying similar safety and effectiveness. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this type of device in this document, as it's a material rather than a diagnostic or therapeutic system that typically undergoes such evaluations.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (dental material for substantial equivalence), no specific quantitative "acceptance criteria" or "device performance" metrics (like accuracy, sensitivity, specificity, etc.) are explicitly defined or reported in the provided text. Instead, the acceptance is based on demonstrating:
- Substantial Equivalence: The device is substantially equivalent to a legally marketed predicate device.
- Technological Characteristics: The components are the same as or similar to those in the predicate, supporting similar safety and effectiveness.
- Intended Use: The intended use is comparable to the predicate.
The reported "performance" is an assertion of safety and effectiveness based on the shared components with the predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material Composition: All components are found in legally marketed devices. | Met: "All of the components of Amaris® Gingiva Opaquer are found in the legally marketed device Clearfil ST Opaquer/Kuraray Co. Ltd., K001913." |
| Biocompatibility: No additional testing for cytotoxicity, mutagenicity, or biocompatibility is needed due to prior use of components. | Met: "The prior use of all of the components of Amaris® Gingiva Opaquer in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary." |
| Safety and Effectiveness: Demonstrate safety and effectiveness for the intended use. | Met (by assertion of equivalence): "We believe that the prior use of the components of Amaris® Gingiva Opaquer in legally marketed devices and the performance data and results provided support the safety and effectiveness of Amaris® Gingiva Opaquer for the intended use." (The 'performance data and results provided' refers to the basis of substantial equivalence, not a separate clinical performance study with measured outcomes). |
| Intended Use: Device is suitable for aesthetic covering/masking of discoloured hypersensitive necks of teeth, corrections of red-white aesthetics, and masking/lightening of crown/bridge restorations. | Met: The device is stated to be intended for these applications in conjunction with Amaris Gingiva. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of submission. This is a material-based submission for substantial equivalence, not a clinical trial or performance study involving a patient test set. The "data provenance" is indirect, based on the prior regulatory approval and use of the components in the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth was established by experts for a test set in the context of this regulatory submission.
4. Adjudication method for the test set
Not applicable. No test set requiring expert adjudication was 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 device is a dental material, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental material.
7. The type of ground truth used
Not applicable in the typical sense of a diagnostic or screening device. The "ground truth" for this submission is historical and regulatory: that the components used in the device have a track record of safe and effective use in a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This submission does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in the provided text.
§ 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.