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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.

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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Bonding between dentin/enamel and silorane based composite filling materials

Bonding between dentin/enamel and methacrylate based composite filling materials

Bonding mediator for fissure sealing

Hermes Bond 2 is classified as Resin Tooth Bonding Agent (21 C.F.R. § 872.320(1) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restorative material.

Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Hermes Bond 2 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. Being based on methacrylate chemistry itself, Hermes Bond 2 is well suited for bonding methacrylate composites. The compatibility to silorane based composites is ensured by the formulation of Hermes Bond 2 which has especially becu optimized for this purpose. In fact, the bond strength obtained for Hermes/Hermes Bond 2 is comparable to that of Adper Prompt L-Pop with conventional methacrylate composites.

Hermes Bond 2 is also intended to be used as a bonding mediator for fissure sealing as is Adper Prompt L-Pop.

Like Adper Prompt L-Pop, Hermes Bond 2 will be available in single dose applicators and in a two-vial version.

The provided text is a 510(k) summary for a dental adhesive called Hermes Bond 2. It details the device's classification, comparison to predicate devices, and a statement on safety and effectiveness. However, it does not contain the specific information required to answer your request about acceptance criteria and the study proving the device meets those criteria.

The 510(k) summary makes a general statement that "The comparison for chemistry, performance data and indications for use shows that Hermes Bond 2 is substantially equivalent to the predicate devices" and "In summary, it can be concluded that safety and effectiveness requirements for Hermes Bond 2 are completely met." It also mentions that "biocompatibility testing was carried out. The results show that Hermes Bond 2 is a safe device."

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Information on a standalone (algorithm only) performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices (Adper Prompt L-Pop, RelyX Unicem, Protemp 3 Garant) based on chemistry, performance data (implied to be comparable bond strength), and indications for use, rather than presenting a detailed study with specific acceptance criteria and results. The "performance data" mentioned is likely referring to bond strength, with the statement that "the bond strength obtained for Hermes/Hermes Bond 2 is comparable to that of Adper Prompt L-Pop with conventional methacrylate composites," but no specific metrics or acceptance criteria are given.

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Bonding between dentin/enamel and silorane based composite filling materials Bonding between dentin/enamel and methacrylate based composite filling materials

Hermes Bond 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 a restorative material. Like Adper Prompt L-Pop, 3M ESPF's well-known and well-established resin bonding agent, Hermes Bond offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible crrors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itsclf, Hermes Bond is well suited for bonding methacrylate composites. The compatibility to silorane based composites is ensured by the formulation of Hermes Bond which has especially been optimized for this purpose. The acidic methacrylates provide efficient etching of the dental hard tissue and initiation of the polymerization of the siloranc-based composite (e.g. "Hermes")at the interface with the adhesive. The blend of co-monomers allows at the same time formation of a uniform adhesive film on dentin and enamel, and additional chemical crosslinking between OHfunctionalized methacrylates and siloranes.

The provided document is a 510(k) summary for a dental adhesive, "Hermes Bond." It discusses the device's characteristics, intended use, and substantial equivalence to predicate devices. However, it does not contain the information required to answer the specific questions about acceptance criteria and a study proving device performance as it pertains to AI/algorithm performance.

The document describes a traditional medical device (a dental bonding agent) and its regulatory clearance process, which focuses on demonstrating substantial equivalence to existing devices through chemistry, performance data (like bond strength), and indications for use. It does not mention any AI component, algorithms, or studies involving human readers, ground truth establishment, or training/test sets for AI models.

Therefore, I cannot extract the requested information from the provided text. The questions posed ("Acceptance criteria and the study that proves the device meets the acceptance criteria," including details like "Sample sized used for the test set," "Number of experts used," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "sample size for the training set") are typically relevant for evaluating AI/machine learning medical devices, which this document does not describe.

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