Search Results

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.

Ask a specific question about this device