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Ascent Bond Universal Adhesive System is indicated for direct bonding to and desensitizing of dentin and enamel, and direct bonding to composite, porcelain, and base metals.

The Ascent Bond 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 text is a 510(k) summary for the Ascent Bond Universal Adhesive System. This document outlines the device's substantial equivalence to predicate devices, its intended uses, and technological characteristics. However, it explicitly states "Performance Standards: None" and refers to "Part 7: Performance Data" which is not included in the provided snippets.

Therefore,Based on the information provided, it is not possible to describe the acceptance criteria, reported device performance, or the details of any study that proves the device meets acceptance criteria. The document states "Performance Standards: None" and does not include the "Part 7: Performance Data" which would contain such information.

Here's what can be stated based on the available text:

General Information from the 510(k) Summary

• Device Name: Ascent Bond Universal Adhesive System
• Manufacturer: CAO Group, Inc.
• 510(k) Number: K092616
• Product Classification: Agent, Tooth Bonding, Resin (21 CFR 872.3200, Product Code: KLE)
• Intended Uses: Direct bonding to and desensitizing of dentin and enamel, and direct bonding to composite, porcelain, and base metals.
• Predicate Devices:
  • Ascent Universal Adhesive (K070413)
  • Gluma Comfort Bond + Desensitizer (K992292)
• Rationale for Substantial Equivalence: Similar indications for use, ingredients, application methods, and composition to predicate devices.
• Performance Standards: None explicitly stated as required for the device. The document mentions "Performance Data" but this section is not provided.

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance: Cannot be provided. The document explicitly states "Performance Standards: None" and the section containing "Performance Data" is not included.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Cannot be provided. This information would be within the "Performance Data" section, which is missing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Cannot be provided. This information would be within the "Performance Data" section, which is missing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Cannot be provided. This information would be within the "Performance Data" section, which is missing.
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 device is a dental adhesive, not an AI software or diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a dental adhesive, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Cannot be provided. This information would be within the "Performance Data" section, which is missing. The concept of "ground truth" as typically applied to diagnostic algorithms or AI models doesn't directly apply to a dental adhesive in the same way. Performance data for an adhesive would typically involve mechanical testing (e.g., bond strength, shear strength) or clinical trials observing its efficacy over time.
8. The sample size for the training set: Not applicable. This device is a dental adhesive, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable. This device is a dental adhesive, not an AI model.

In summary, the provided 510(k) summary primarily focuses on establishing substantial equivalence based on composition and intended use, rather than presenting detailed performance study results with specific acceptance criteria.

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