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Ascent Universal Adhesive is intended for all direct and indirect restorations where light cure is possible. It is indicated as an adhesive for: light cured restorative composites, Methacrylate resin cements, dentin, enamel, metal alloys and porcelain.

Ascent Universal Adhesive is indicated for direct bonding to:

• Dentin
• Enamel
• Composite
• Porcelain
• Metal

The Ascent Universal Adhesive is an ethanol-based composition containing a special formulation of resins to achieve an excellent bond to materials such as restorative composites, dentin, enamel, metals and porcelain. The composition is polymerized by means of a dental polymerization light source.

The provided document is a 510(k) summary for a dental adhesive, Ascent Universal Adhesive. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting an extensive study with detailed acceptance criteria and performance metrics typically found for AI/software-as-a-medical-device.

Based on the content of the provided text, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document explicitly states "Performance Standards: None" and "Performance Data: See Part 7: Performance Data". Since "Part 7: Performance Data" is not included in the provided text, a table of specific acceptance criteria and reported device performance cannot be created from the given information. The submission relies on demonstrating substantial equivalence to a predicate device rather than meeting specific performance metrics against defined acceptance criteria.

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

   No information is provided regarding a "test set" or its sample size or data provenance. The submission focuses on comparing the proposed device's characteristics to a predicate device rather than conducting a performance study on a test set.

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

   Not applicable. There is no mention of a test set, ground truth establishment, or experts involved in such a process.

4. Adjudication method for the test set:

   Not applicable. No test set is described.

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/software-as-a-medical-device submission. No MRMC study or AI assistance is mentioned.

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

   Not applicable. This is not an AI/software-as-a-medical-device submission.

7. The type of ground truth used:

   Not applicable. There is no concept of "ground truth" as relevant to performance evaluation of an AI-driven device in this document. The assessment is based on material composition, intended use, and application methods compared to a predicate device.

8. The sample size for the training set:

   Not applicable. This is not an AI/software-as-a-medical-device submission; therefore, there is no training set.

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

   Not applicable. There is no training set mentioned in the document.

Summary of what is present in the document regarding acceptance criteria and studies:

The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Prime & Bond NT Dual Cure, K982394). The "acceptance criteria" in this context are implicit in the FDA's regulatory framework for 510(k)s, meaning the device must be as safe and effective as the predicate device.

The study or data proving this substantial equivalence is described as:

• Rationale for Substantial Equivalence:
  • Shared similarities in use in the oral environment.
  • Similar indications for use.
  • Similar application methods.
  • "Similar active constituents in similar concentrations."
  • "Exact information regarding the material's constituents is found in Part 6: Specifications." (This indicates that the "study" is likely a comparison of material specifications and performance data, which is mentioned as being in "Part 7: Performance Data" but not provided in the extract).

The "study" here is not a clinical trial or an AI performance study, but a technical comparison of the material properties, composition, and intended use against a previously cleared device. The "acceptance criteria" are met if the FDA agrees that the similarities are sufficient to declare the new device substantially equivalent to the predicate, "without raising any new issues regarding safety and/or effectiveness."

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