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All-Bond Universal SC adhesive is used for:

• Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, core build-ups)
• Indirect Restorations (e.g. metal, glass, ceramics, zirconia/alumina)
• Bonding Resin or Primer for Substrates
• Desensitization/Sealing of Tooth
• Intraoral Repair (e.g. chipped porcelain, additions to direct restorations)

All-Bond Universal SC is an auto-polymerizing adhesive with a light-curing alternative. It is designed for the dentist who prefers not to light cure the adhesive layer under indirect restorations. All-Bond Universal SC has a low film thickness (<5 µm). All-Bond Universal SC has a chemical formulation that allows the adhesive to be used in either self-etch or total-etch mode, based on the clinical situation and dentist preference. All-Bond Universal SC is compatible with light-cured, self-cured, dual-cured resin composite and cement base materials for direct and indirect procedures without any additional activators.

The provided text is a 510(k) summary for a dental adhesive, "All-Bond Universal SC," indicating its substantial equivalence to a predicate device, "ACE Bond SE." The summary focuses on chemical composition, physical/mechanical properties, and biocompatibility rather than clinical performance based on a test set and ground truth in the way one might expect for an AI/CADe device. Therefore, many of the requested categories about acceptance criteria, study design for a test set, expert involvement, and ground truth are not applicable or cannot be extracted from this document, as it describes a traditional dental adhesive, not a diagnostic or AI-powered medical device.

However, I can extract the information that is present and indicate where the requested information is not available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is described as "R&D testing protocols" conducted in the lab. These protocols were used to determine shear bond strength, microleakage, and film thickness (using a modified technique from ISO 4049). An evaluation of biocompatibility was conducted using ISO 7405:2008 and an Oral Toxicity Study (10 rats, 14 days). The conclusion is based on "Side by side comparisons" demonstrating substantial equivalence to the predicate device.

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

• Sample Size for Test Set:
  • For physical/mechanical properties (shear bond strength, microleakage, film thickness): Not explicitly stated. The document mentions "R&D testing protocols" but does not quantify the number of samples or tests.
  • For Biocompatibility: 10 rats were used for the Oral Toxicity Study.
• Data Provenance: The studies were conducted in the lab by BISCO, Inc. (location: Schaumburg, IL, USA). The studies are retrospective regarding their submission date, as the tests were performed prior to filing the 510(k).

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

• This information is not applicable to this type of device and study. The "ground truth" for a dental adhesive focuses on its physical, chemical, and biological properties, which are measured using established scientific/engineering methods and standards (e.g., ISO standards, R&D protocols), not typically through expert consensus readings of images or clinical cases.

4. Adjudication method for the test set:

• This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic studies, not for the analytical testing of material properties.

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:

• This information is not applicable. This is not an AI/CADe device, and therefore, no MRMC study was performed as described.

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

• This information is not applicable. This is not an AI/CADe device.

7. The type of ground truth used:

• The "ground truth" for the performance claims relies on:
  • Measurements against industry standards/protocols: For film thickness (modified ISO 4049) and biocompatibility (ISO 7405:2008).
  • Results from R&D testing protocols: For shear bond strength and microleakage.
  • Direct chemical and physical comparisons to a legally marketed predicate device.

8. The sample size for the training set:

• This information is not applicable. This is not an AI/CADe device, and therefore, there is no "training set" in the context of machine learning.

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

• This information is not applicable. As there is no training set for an AI model, there is no ground truth established for such a purpose.

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