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When used with the CLEARFIL BONDING SYSTEM, the product is indicated for the following uses.

[1] Core build-up in conjunction with self- or dual- cured core build-up materials

[2] Cementation in conjunction with self- or dual- cured composite resin cements

The subject device activates the dual-curing mechanism of the CLEARFIL BONDING SYSTEM (c.g. CLEARFIL SE BOND 2 or CLEARFIL SE Protect). The product is mixed with the BOND and can be used with dual-cure or self-cure composite filling materials, cements, or core build-up materials.

This document describes the CLEARFIL DC Activator, a dental product designed to activate the dual-curing mechanism of the CLEARFIL BONDING SYSTEM. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for the tensile bond strength tests on bovine enamel and dentin. However, it indicates that comparisons were made to a predicate device.

The provenance of the data is not specifically mentioned regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a dental product, it is most likely laboratory-based testing conducted by the manufacturer, which would be prospective in nature.

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

Not applicable. This device is a chemical activator for a bonding system, and its performance is evaluated based on objective physical properties (tensile bond strength), not subjective interpretation by experts. Ground truth in this context is established by the results of the physical tests themselves.

4. Adjudication Method for the Test Set

Not applicable. The evaluation relies on quantitative measurements (tensile bond strength), not on expert consensus or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices where human readers assess outputs (e.g., medical imaging). This device is a chemical product, and its performance is assessed through physical property testing.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance assessment was done. The "device" in this context is the CLEARFIL DC Activator itself, and its performance (tensile bond strength) was measured directly. There is no "human-in-the-loop" aspect to its function or evaluation, as it is a chemical component.

7. Type of Ground Truth Used

The ground truth used was objective physical measurements (tensile bond strength) obtained from laboratory testing. The comparison was made against the performance of a predicate device, establishing statistical equivalence or non-inferiority.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set." The performance is determined through experimental testing, not through model training.

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

Not applicable, as there is no training set for this device.

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XENO® ADHESIVE WITH ACTIVATOR is indicated for:

• direct, light-cured composite and compomer restorations; .
• indirect restorations; .
• light-cured resin cemented veneers; .
• composite, ceramic, and amalgam repairs; .
• cavity varnish for use with fresh amalgam; .
• Cavity varmsil for asself-cure composite restorations and core build-ups; .
• unfect, dual-cure of sen care compoon and bridge retainers, and endodontic post . cementation; and .
• adhesive bonding of direct amalgam restorations. .

XENO® ADHESIVE WITH ACTIVATOR is a dual-cure, self-etch, two-component adhesive system. It utilizes the same XENO® adhesive found in the predicate (wo-component activator found in the Prime & Bond® NT™ adhesive system. When the selfand the same actrator roans in me on with the self-cure activator, it forms an adhesive layer that bonds to self-curing cements.

The provided document is a 510(k) premarket notification for a dental adhesive. It details the device description, intended use, technological characteristics, and regulatory correspondence. However, it does not contain information about acceptance criteria, specific study results, sample sizes for test/training sets, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting detailed performance study data against defined acceptance criteria.

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