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tenure@4G is recommended for the following types of applications:

1. All routine direct and indirect resin composite bonding

2. Porcelain, ceramic veneers, amalgams, precious and semi-precious metals bonding

3. Indirect gold, porcelain and ceramic inlays and onlays bonding

4. Desensitization of root or dentin prior to impressions or temporaries

5. Preparation desensitization of crown prior to impressions or temporaries

tenure * 4G is DenMat's next generation of its popular Tenure MPB System with greater bond strength and sensitivity control. It is a 40 generation multi-purpose, self-cure adhesive system for bonding any resin restorative to all intraoral surfaces. They are polymerizable dental monomer resins that are chemically-cured with the reaction initiated when the two parts are mixed together. These polymers form strong leak and stain resistant bonds between the dental surface and restorations placed over them.

This document is a 510(k) premarket notification for the "tenure®4G" resin tooth bonding agent. It evaluates the device's substantial equivalence to predicate devices (ALL-BOND 2 and Tenure MPB) based on intended use, indications for use, chemical components, safety, and technological characteristics.

Here's an analysis of the provided information concerning acceptance criteria, device performance, and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate devices, particularly in terms of shear bond strength. While explicit numerical acceptance criteria (e.g., "must achieve at least X psi") are not stated, the study aims to show that the tenure®4G performs "as good as or even better than the predicate devices."

Conclusion from Table: For Porcelain and Enamel, tenure®4G demonstrates higher mean bond strength than ALL-BOND 2, and for Enamel and Dentin, it shows higher mean bond strength than Tenure MPB. For Porcelain, its mean bond strength is slightly lower than Tenure MPB but falls within the standard deviation. Overall, the results support the claim that tenure®4G performs "as good as or even better than" the predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "Results of shear bond testing indicate that tenure®4G was as effective and performs as good as or even better than the predicate devices." However, it does not explicitly state the sample size used for the shear bond testing. The data provenance is not specified beyond being "tested in the lab using R&D test protocols." It is likely retrospective data collected for this submission. The country of origin of the data is not mentioned but can be inferred to be related to the submitter, DenMat Holdings, LLC, which is based in Lompoc, California, U.S.A.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of study (comparative performance of a dental bonding agent) does not involve experts establishing ground truth in the same way clinical diagnostic studies do. The "ground truth" here is the objective measurement of shear bond strength, which is a physical property determined through laboratory testing methods, not expert consensus or interpretation. Therefore, this information is not applicable.

4. Adjudication Method for the Test Set

As the "test set" involves objective laboratory measurements of shear bond strength rather than subjective assessments requiring expert adjudication, this information is not applicable.

5. 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

This document describes the performance of a dental bonding agent, an in-vitro material, not a diagnostic imaging device or an AI application. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This document pertains to a dental bonding agent and not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this performance study is objective laboratory measurements of shear bond strength. This is determined through physical testing protocols in a lab setting, not through expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This submission is for a medical device (dental bonding agent), not a machine learning algorithm. Therefore, there is no concept of a "training set" in this context. The chemical formulation and manufacturing processes are developed through research and development, and the performance is validated through testing, not by training a model on data.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for this device, this question is not applicable.

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