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Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used to seal small defects such as buccal pits, lingual grooves or facial surface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.

Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used small defects such as puch pins, lingual grooves or facial sufface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.

The provided text describes a 510(k) premarket notification for the Embrace™ WetBond™ Clear Sealant. This notification asserts substantial equivalence to existing predicate devices based on design, composition, and intended use, rather than presenting a study to define and meet specific acceptance criteria in the way that would typically be done for a novel AI/software device.

Therefore, many of the requested categories for AI/software device studies are not applicable to this submission. The submission relies on existing knowledge about the safety and effectiveness of the chemical components and predicate devices, supported by laboratory testing on physical/mechanical properties and post-market surveillance of similar products.

Here's an attempt to address the requested information based on the provided text, indicating where information is not applicable (N/A) due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

• Penetration depth and marginal leakage
• Microleakage of surface sealants
• Toothpaste/toothbrush abrasion resistance
• Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant. | While not direct studies on the Clear Sealant, these serve as evidence of the effectiveness of the underlying resin technology, supporting the claim of substantial equivalence. |
  | Safety - Post-Market Surveillance | Four years of post-market surveillance of the two Pulpdent predicates has demonstrated only positive feedback, with no serious complaints, failures, or injuries. | This provides real-world safety data for similar materials. |
  | Safety - General Usage | NIH Technology Assessment Conference states: "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States." | This broad statement on the safety of dental restorative materials (composites and glass ionomers) provides context for the safety of this type of device. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not explicitly stated for specific tests directly of the Embrace™ WetBond™ Clear Sealant within this summary. The "four studies" were conducted on "similar products with the same Embrace™ WetBond™ resin base." One clinical study is mentioned ("Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant. Dr. JP O'Donnell. 2005."), but the sample size and provenance details are not provided in this submission summary.
• Data provenance:
  • "Penetration depth and marginal leakage..." - Professor Michael DeGrange, Biomaterials Innovations Research Development Laboratory, Paris, France. (2001, 2002)
  • "Microleakage of surface sealants in Class V restorations after thermal cycling." - Pulpdent Corporation.
  • "In vitro study on toothpaste / toothbrush abrasion resistance of a new dental material: Seal-n-Shine." - Pulpdent Corporation.
  • "Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant." - Dr. JP O'Donnell. (2005)
  • The studies mentioned appear to be a mix of in-vitro (laboratory) and potentially in-vivo (clinical) based on their titles. The submission doesn't explicitly state if the clinical study was prospective or retrospective here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A. For direct testing of the Embrace™ WetBond™ Clear Sealant, the submission relies on laboratory testing and reference to prior studies, not on expert consensus to establish ground truth in the context of diagnostic performance. For the referenced studies, the experts are listed as "Professor Michael DeGrange" and "Dr. JP O'Donnell," implying their scientific and clinical expertise, respectively, but no panel or number of experts for "ground truth" establishment is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving human interpretation of diagnostic results. This submission focuses on material properties and clinical performance of a sealant, not diagnostic interpretation.

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

• N/A. This device is a pit and fissure sealant, not an AI or diagnostic imaging device. Therefore, MRMC studies and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A. This device is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the laboratory studies, the "ground truth" would be established by the physical and mechanical measurement standards and protocols relevant to dental materials (e.g., measuring penetration depth, leakage, abrasion resistance).
• For the clinical study, "outcomes data" related to sealant performance (e.g., retention, caries prevention) would be the ground truth.
• For substantial equivalence, the "ground truth" is defined by the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• N/A. This is a material device, not a machine learning model. There is no "training set."

9. How the ground truth for the training set was established

• N/A. As there is no training set for a machine learning model, this question is not applicable.

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