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The TOKUYAMA BOND FORCE is a one-component, one-coat application, self-etching, light-cured, fluoride-releasing dental adhesive system. The adhesive can be cured using a light curing unit with a camphorquinone (CQ) wavelength range (400 - 500 mm range). The device is intended for the bonding of light- or dual-cured composite material to (i) cut or uncut enamel, (ii) cut or uncut dentin, or (iii) fractured porcelain or composite for repair.

TOKUYAMA BOND FORCE is a one-component, one-coat application, self-etching, light-cured, fluoride-releasing dental adhesive system. The adhesive can be cured using a light curing unit with a camphorquinone (CQ) wavelength range (400 - 500 mm range).

The provided text is a 510(k) summary for a dental resin bonding agent (TOKUYAMA BOND FORCE). It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way typically expected for a medical device with measurable performance metrics like sensitivity, specificity, or image quality.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on general characteristics. The core of this 510(k) is a comparison of technological characteristics like biocompatibility, bond strength, and fluoride release rate, rather than reporting on specific performance metrics against pre-defined acceptance criteria.

Therefore, many of the requested categories cannot be populated from the provided document.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified. (The document mentions the sponsor is from Tokyo, Japan, but this doesn't indicate the origin of any test data).
• Retrospective/Prospective: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. The document does not describe a "test set" in the context of clinical or diagnostic performance evaluated by experts.

4. Adjudication Method for the Test Set

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

• No, a MRMC comparative effectiveness study was not mentioned or performed for this type of device (dental bonding agent).

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

• Not applicable. This is a physical dental material, not an algorithm or AI device.

7. The Type of Ground Truth Used

• Not applicable in the context of clinical performance ground truth. For material characteristics like bond strength and fluoride release, the "ground truth" would be established through standardized laboratory testing methods, but the specifics are not detailed in this summary.

8. The Sample Size for the Training Set

• Not applicable. This is a physical dental material, not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable.

Summary of Device Rationale for Acceptance:

The basis for the device's acceptance (510(k) clearance) is substantial equivalence (as stated in section {1} and {2} of the text) to multiple predicate devices. This means that instead of proving the device meets specific quantitative performance acceptance criteria through a novel study, the manufacturer demonstrated that its technological characteristics (biocompatibility, bond strength, and fluoride release rate) are similar enough to already legally marketed devices, such that it "does not raise new questions of safety or effectiveness." The specific data supporting these claims (e.g., bond strength values, fluoride release rates, biocompatibility test results) would have been included in the full 510(k) submission, but they are not detailed in this summary document.

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