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CLEARFIL ST OPAQUER is indicated for the following applications:

1. Masking of metal during intraoral repair of porcelain fused-to-metal crowns.
2. Masking of metal in restoration of post and core crowns.
3. Lightening of stained or discolored teeth in porcelain or composite veneer restorations.
4. Masking of pulp capping materials.

CLEARFIL ST OPAQUER is classified into the Tooth Shade Resin Material, CFR 21 Section 872.3690. because it is a device composed of materials such as bisphenol-A glycidylmethacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

This document is related to a 510(k) submission for a dental material, CLEARFIL ST OPAQUER. The submission is not for a new device, but rather a change in manufacturer (from Kuraray Co., Ltd. to Kuraray Medical Inc.) for an already cleared device. Therefore, a study demonstrating the device meets acceptance criteria is not provided or required. The core of this submission is to assert "substantial equivalence" to a predicate device, meaning it has the same intended use, technological characteristics, and safety profile as the device already on the market.

Based on the provided document, there is no study detailed that proves the device meets specific acceptance criteria in the way one would for a novel medical device requiring performance testing.

The document states:

• "This device is essentially the same as CLEARFIL ST OPAQUER manufactured by Kuraray Co., Ltd. (K001913). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL ST OPAQUER."

This statement is the central "proof" for this 510(k) submission. The acceptance criteria are implicitly met because the device is identical to a device already cleared by the FDA (predicate device K001913).

Therefore, most of the requested information regarding study details (sample sizes, experts, adjudication, MRMC, standalone performance, ground truth establishment, training set) is not applicable to this type of regulatory submission.

However, I can extract the acceptance criteria (intended uses) and explain the "proof" presented in this specific context:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Proof": The core argument is based on substantial equivalence. The new applicant (Kuraray Medical Inc.) asserts that their device is identical in composition and function to a predicate device (CLEARFIL ST OPAQUER from Kuraray Co., Ltd. K001913) that has already been cleared by the FDA for these specific indications. No new performance data is presented because the device itself is not new; only the manufacturer's name/address is being updated in the regulatory filing.

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

• Not applicable. No new performance study was conducted. The "test set" is the predicate device's existing performance, implicitly accepted by the FDA.

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

• Not applicable. No new performance study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No new performance study was conducted.

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 a dental material, not an AI-powered diagnostic device.

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

• Not applicable. This is a dental material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. Performance data is not part of this specific 510(k) summary because it's a manufacturer change, not a new device. The implicit ground truth for the predicate device would have been established through prior testing and clinical use, but those details are not in this document.

8. The sample size for the training set:

• Not applicable. This is a dental material, not an AI-powered device that requires a training set.

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

• Not applicable. This is a dental material.

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