(46 days)
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.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.