(74 days)
EASY GLAZE is intended for the following applications:
- Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations.
- Sealing the adhesive interfaces between restoration and tooth structure.
- Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement.
- Sealing glass ionomer cement liners/build-up restorations before taking impressions.
EASY GLAZE is a nanofilled, light-curing coating with natural fluorescence for sealing surfaces. The coated surface is luminous, provides protection against discolouration and yields a natural appearance. EASY GLAZE can be polymerised with all light-curing dental devices.
The provided text is a 510(k) Summary for a dental device called "EASY GLAZE". This document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving the device meets them.
Here's a breakdown of why the requested information isn't fully available and what can be inferred:
The core argument for the "EASY GLAZE" device is that all of its components are found in legally marketed predicate devices. This approach (often called "component-based substantial equivalence") implies that if the components are safe and effective in other approved devices, the new device using those same components will also be safe and effective for its stated intended use.
Therefore, many of the requested criteria related to a dedicated performance study with specific acceptance criteria, sample sizes, expert ground truth, etc., are not present in this type of 510(k) submission.
Here's an attempt to answer your questions based on the provided text, highlighting what is not applicable or not disclosed:
Acceptance Criteria and Study for EASY GLAZE
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance tests. The implicit acceptance criterion is "substantial equivalence" to the predicate devices.
- Reported Device Performance: The primary "performance" reported is the assertion that "The prior use of all of the components of EASY GI.AZE 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." This indicates that the performance is benchmarked against the established performance of its components in predicate devices. No specific quantitative performance metrics (e.g., bond strength, wear resistance) are provided for EASY GLAZE itself in this summary.
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not applicable/not disclosed. No dedicated "test set" for a performance study of the final EASY GLAZE formulation is mentioned because the argument relies on component equivalence.
- Data Provenance: Not applicable. The "data" used is the regulatory history and prior approval of the components in other devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not disclosed. Ground truth establishment for a new performance study is not described.
4. Adjudication method for the test set:
- Adjudication Method: 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:
- MRMC Study: Not applicable. This device is a dental coating, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an algorithm.
7. The type of ground truth used:
- Ground Truth: For the purpose of this 510(k), the "ground truth" implicitly relies on the established safety and effectiveness of the individual components of EASY GLAZE, as demonstrated by their prior approval in the predicate devices (K052462, K043168, K974772, K070306). There is no "ground truth" derived from a new, independent study of EASY GLAZE's performance explicitly mentioned.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not a machine learning/AI device, so there is no training set in the typical sense.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
Summary of Approach:
This 510(k) summary uses the "substantially equivalent" pathway by arguing that EASY GLAZE is composed entirely of components already found in other legally marketed devices. Therefore, the burden of requiring new, extensive performance studies (which would have specific acceptance criteria, sample sizes, ground truth establishment, etc.) directly on the EASY GLAZE product is reduced. The "study" referenced is essentially the regulatory history and established safety/effectiveness profiles of the individual components and the predicate devices themselves.
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.