(80 days)
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:
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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.
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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).
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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.
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Adjudication method for the test set: Not applicable. (See #3)
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/SaMD study.
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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.
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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.
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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.
§ 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.