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510(k) Data Aggregation
(71 days)
Bonding between dentin/enamel and 3M ESPE silorane (or oxirane) based composites
Hermes Bond 3 is classified as Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. Hermes Bond 3 offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Hermes Bond 3 is intended to provide bonding between dentin/enamel and silorane (or oxirane) based composites. This is ensured by the formulation of Hermes Bond 3 which has especially been optimized for this purpose. Hermes Bond 3 will be available in a two-vial version, one containing the Hermes Bond 3 Primer and one containing the Hermes Bond 3 Link (Bond).
The provided text describes a 510(k) premarket notification for a dental adhesive named "Hermes Bond 3." It is a regulatory document focused on establishing substantial equivalence to predicate devices, rather than a detailed study report on device performance based on acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It makes a qualitative statement about meeting safety and effectiveness requirements. The "performance" described is in the context of the device's function and advantages.
| Acceptance Criteria (Not explicitly stated as such) | Reported Device Performance (Qualitative descriptions) |
|---|---|
| Safety: Biocompatibility | Results of biocompatibility testing show that Hermes Bond 3 is a safe device. |
| Effectiveness/Functionality: improved retention of restorative materials | Intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. |
| Effectiveness/Functionality: bonding between dentin/enamel and silorane (or oxirane) based composites | Hermes Bond 3 is intended to provide bonding between dentin/enamel and silorane (or oxirane) based composites. This is ensured by the formulation of Hermes Bond 3 which has especially been optimized for this purpose. |
| Advantages over previous methods: Simplified bonding procedure, reduced application errors, reduced post-operative sensitivity, saved chair time | Offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. |
| Substantial Equivalence: Chemistry, performance data, indications for use compare to predicate devices | The comparison for chemistry, performance data and indications for use shows that Hermes Bond 3 is substantially equivalent to the predicate devices (Hermes Bond 2, Adper Prompt L-Pop, RelyX Unicem, ESPE Sil, Sinfony - all by 3M ESPE). In summary, it can be concluded that safety and effectiveness requirements for Hermes Bond 3 are completely met. |
Study Details (Missing Information)
The provided text is a 510(k) summary, which focuses on establishing substantial equivalence rather than detailing a specific clinical or performance study with the requested metrics. Therefore, the following information is not present:
- Sample size used for the test set and the data provenance: Not mentioned. The document refers to "biocompatibility testing" and "comparison for chemistry, performance data," but doesn't provide details on the test set for these comparisons.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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, as this is a dental adhesive, not an AI diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a dental adhesive, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For biocompatibility, it would typically be based on established biological tests and standards. For performance, it would likely be laboratory or in-vitro tests comparing bond strength, durability, etc., against predicate devices, but these details are not provided.
- The sample size for the training set: Not applicable, as this is a dental adhesive, not a machine learning model.
- How the ground truth for the training set was established: Not applicable, as this is a dental adhesive, not a machine learning model.
In summary: The document is a regulatory submission demonstrating substantial equivalence for a dental bonding agent. It confirms that biocompatibility testing was performed and that the device's chemistry, performance, and indications for use are comparable to legally marketed predicate devices, thereby meeting safety and effectiveness requirements. However, it does not provide the detailed study parameters, acceptance criteria, or performance data that would be typical for a clinical study report of a diagnostic device or AI algorithm.
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