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This device is indicated for direct dental bonding applications.

3M™ Dent System II Plus is a two part, radiopaque dual-curing luting composite. This device, as well as the predicate devices, are based on methacrylate resin chemistry. The 3M™ Dent System II Plus Paste A alone can be cured by exposure to a dental visible light curing unit. When Pastes A and B are mixed, the material will chemically cure without exposure to light or can be cured by exposure to visible light.

The provided text does not contain information about acceptance criteria for a medical device or a study proving that a device meets such criteria. Instead, it is a 510(k) summary and an FDA clearance letter for a dental product called "3M™ Dent System II Plus."

The document primarily focuses on:

• Identification of the device: 3M™ Dent System II Plus, a two-part, radiopaque dual-curing luting composite.
• Intended Use: Used in conjunction with a dental adhesive system to bond direct and indirect restorations.
• Predicate Devices: 3M™ Scotchbond™ Resin Cement, Bisco Resinomer™, Bisco Duolink™.
• Technological Characteristics: Based on methacrylate resin chemistry, similar to predicate devices.
• Evidence of Substantial Equivalence: Demonstrated through "comparative results of the bench tests conducted." These tests include:
  • Shear bond strength
  • Compressive strength
  • Diametral tensile strengths
  • Film thickness

The document does not provide the following information from your request:

1. A table of acceptance criteria and the reported device performance: While specific bench tests are mentioned (shear bond strength, compressive strength, etc.), the document does not list the acceptance criteria for these tests (e.g., minimum shear bond strength required) nor the actual performance values achieved by the 3M™ Dent System II Plus. It only states that the results "validated" similar technological characteristics and that the device "performs as well or better than the predicate devices."
2. Sample size used for the test set and the data provenance: No information is given about the sample sizes for the bench tests or where the data came from.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As this is a dental cement, "ground truth" in the context of clinical expert review is not applicable here. The performance is assessed via laboratory bench tests.
4. Adjudication method for the test set: Not applicable for bench tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a dental cement, not an imaging or diagnostic device requiring human reader interpretation.
6. If a standalone performance (algorithm only) was done: Not applicable, as this is a physical dental product, not a software algorithm.
7. The type of ground truth used: For a dental cement, "ground truth" is typically defined by objective physical and mechanical properties measured in a laboratory (e.g., actual bond strength, actual compressive strength). The document only generally refers to the results of "bench tests."
8. The sample size for the training set: Not applicable, as this refers to a physical product and not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

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The 3MM Dent System is substantially equivalent to the predicate devices above in that all are intended to be used as a 21 CFR 872.3200 resin tooth bonding agent. 3MM Dent System is substantially equivalent to One Step™ Universal in terms of indications.

a simple adhesive system that offers the dental practitioner a wide range of applications. The 3MM Dent System is substantially equivalent to the predicate devices above in that all are intended to be used as a 21 CFR 872.3200 resin tooth bonding agent. 3MM Dent System is substantially equivalent to One Step™ Universal in terms of indications.

The design of the 3M™ Dent System is substantially equivalent to the predicate devices above because all utilize a phosphoric acid etchant and a methacrylate resin that will polymerize upon exposure to visible light from a dental light curing unit. The 3MTM Dent System, Prime & Bond™ and One Step™ Universal all utilize a resin that is intended to function as both primer and adhesive.

This document is a 510(k) summary for a dental adhesive system (3M™ Dent System resin tooth bonding agent system). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain the type of information typically associated with evaluating a device's performance against specific acceptance criteria using a study with detailed statistical outcomes, ground truth, or expert review for diagnostic AI/imaging devices.

Therefore, I cannot fulfill your request to describe acceptance criteria and study details based on the provided text.

Here's why and what kind of information would be needed:

• Type of Device: The 3M™ Dent System is a resin tooth bonding agent, a dental material. Your request implies a diagnostic device, particularly one involving AI, imaging, and human reader performance, which requires very different types of evaluations.
• Performance Metrics: For a dental adhesive, "performance" is typically measured by metrics like:
  • Bond strength (to dentin, enamel, various dental materials)
  • Dentin permeability
  • Microleakage
  • Biological safety
• Lack of AI/Diagnostic Study Elements: The summary makes no mention of:
  • Acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC)
  • Test sets, training sets, or data provenance
  • Expert readers, ground truth establishment, or adjudication
  • MRMC studies or standalone algorithm performance
  • Sample sizes for anything other than potentially biological safety testing.

The provided text focuses on demonstrating "substantial equivalence" to predicate devices based on material properties and biological safety, not on diagnostic accuracy of an AI system.

To answer your questions for an AI/diagnostic device, the input document would need to contain information similar to what you would find in a clinical study report or a 510(k) submission for a software as a medical device (SaMD) product that performs diagnosis or detection.

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