(78 days)
Generation 8 SE Adhesive product is indicated for direct bonding of composite and compomer materials to enamel and dentin. Additionally, device use is appropriate for adhesive bonding of other dental materials, such as composite material to ceramics, composite material to composite material and composite material to metals and amalgam.
The subject device is a light-cured self-etching, self-priming adhesive in a solvent-free resin formulation. The Generation 8 SE Adhesive performs the etching/priming/bonding process as a single step once the restorative site has been properly prepared. Device composition is approximately 40% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Generation 8 SE Adhesive is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.
The given text is a 510(k) summary for the "Generation 8 SE Adhesive" device. It describes the device, its intended use, and states that a review for safety and effectiveness was performed and found not to have been affected. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
The document states: "A review for safety and effectiveness was performed and found not to have been affected." This is a general statement and does not provide quantifiable acceptance criteria or the specific performance metrics of the device as would be presented in a formal study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The document does not specify quantitative acceptance criteria or detailed performance data.
- Sample sized used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method: This information is not present.
- Multi reader multi case (MRMC) comparative effectiveness study: This information is not present. The document focuses on substantial equivalence to a predicate device, not a comparative effectiveness study with human readers.
- Standalone performance: While the document implies the device performs an intended function, it does not provide detailed standalone performance metrics or studies.
- Type of ground truth used: This information is not present.
- Sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (One Coat SE Bond, K033760) based on intended function, composition, and general performance, rather than presenting a detailed study with specific acceptance criteria and performance data.
§ 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.