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The Everbond® system is intended to bond composite and compomer restorative material to the tooth structure (dentin and enamel)

resin-based tooth bonding system, tradenamed Everbond®. The Everbond® system is intended to bond composite and compomer restorative material to the tooth structure (dentin and enamel), and is composed of an etching gel and a primer/bond formulation.

Here's a breakdown of the acceptance criteria and the study details for the Everbond® system, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided document describes the Everbond® system's substantial equivalence to predicate devices, focusing on shear bond strength. The acceptance criteria are implicitly that the Everbond® system's shear bond strength should be comparable to or not inferior to the predicate device, Dentsply's Multipurpose Dentin/Enamel Bonding Agent Bond & Prime 2.1®. While specific numerical acceptance thresholds are not explicitly stated, the study's purpose is to demonstrate substantial equivalence through comparison.

Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "the shear bond strength of the Everbond® system has been compared to that of Bond & Prime 2.1º by two institutes," but does not specify the number of samples or specimens tested.
• Data Provenance:
  • Country of Origin: USA (University of Houston, Texas) and Germany (University of Regensburg).
  • Retrospective or Prospective: Not explicitly stated, but clinical testing for bond strength is typically prospective.

3. Number of Experts and Qualifications for Ground Truth

Not applicable for this type of device and study. The "ground truth" here is the measured shear bond strength, not expert interpretation of images or clinical outcomes requiring consensus. The "experts" involved are presumably the researchers and technicians at the two university institutes conducting the laboratory tests.

4. Adjudication Method for the Test Set

Not applicable. Shear bond strength is a quantitative, objective measurement, not subject to adjudication in the same way as, for example, diagnostic image interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a dental bonding agent, and its performance is evaluated through material properties like shear bond strength, not through human reader interpretation of cases.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical product (a bonding agent), not an algorithm or AI system.

7. Type of Ground Truth Used

• Shear Bond Strength: The ground truth is the direct measurement of bond strength through standardized laboratory testing methods (e.g., universal testing machine to apply shear force until failure).
• Material Composition: The ground truth is the chemical analysis of the composition of the materials.

8. Sample Size for the Training Set

Not applicable for this submission. The "training set" concept is typically relevant for machine learning algorithms. For a medical device like a dental bonding agent, the development process might involve iterative testing and refinement, but it's not formally referred to as training a model. The provided document focuses on the final validation of the product.

9. How Ground Truth for the Training Set Was Established

Not applicable. (See point 8). The "ground truth" for product development would be based on established dental material science principles, previous product data, and laboratory testing.

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The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent.

3-component resin tooth bonding system, tradenamed EBS® (ESPE Bonding System). The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent.

The provided text is a 510(k) summary for a dental bonding system (EBS®) and does not contain the detailed information required to answer the questions about acceptance criteria, study design, and performance metrics typically found in clinical studies for AI/software-as-a-medical-device (SaMD).

The document focuses on demonstrating substantial equivalence to a predicate device based on shear bond strength testing, which is a physical performance characteristic, not a clinical outcome or diagnostic accuracy.

Therefore, for each point requested:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in terms of a numerical range or threshold for "substantial equivalence." The document implies that the shear bond strength of the EBS® System should be comparable to that of the Scotchbond™ System to achieve substantial equivalence.
   • Reported Device Performance: The document states that "the shear bond strength of the EBS® System has been compared to that of the Scotchbond™ System." However, the actual numerical results of this comparison (e.g., mean shear bond strength for EBS, mean for Scotchbond, p-value of comparison) are not provided in this summary.

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., animal teeth, extracted human teeth, in-vivo human studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study focuses on physical performance (shear bond strength), which doesn't involve "ground truth" derived from expert interpretation in the way AI/SaMD studies do.

4. Adjudication method for the test set: Not applicable. (See #3)

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: Not applicable. This is not an AI/SaMD study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/SaMD study.

7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" here would be the measured shear bond strength, which is an objective physical measurement.

8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is a physical performance test, not a machine learning study.

9. How the ground truth for the training set was established: Not applicable. (See #8)

In summary, the provided document is a 510(k) summary for a dental bonding agent, demonstrating substantial equivalence through a physical performance test (shear bond strength). It lacks the specific details regarding clinical study design, performance metrics (beyond the general mention of comparison), or AI-related information typically requested in your template.

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