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PANAVIA F 2.0 is indicated for the following applications:

• Cementation of metal crowns and bridges, inlays and onlays. 1)
• 2. Cementation of porcelain crowns, inlays, onlays and veneers.
• 3. Cementation of composite resin crowns, inlays and onlays
• Cementation of adhesion bridges 4)
• 5. Cementation of endodontic cores and prefabricated posts
• 6. Amalgam bonding

PANAVIA F 2.0 is classified into dental cement, CFR 21 Section 872.3275, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for cementation of dental devices such as crown and bridges.

The provided text is a 510(k) summary for a dental cement (PANAVIA F 2.0). It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety, rather than providing a study demonstrating performance against specific acceptance criteria like a medical imaging AI device would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI improvement effect size, standalone performance) are not applicable to this type of device and submission.

However, I can extract information related to product specifications and testing that can be interpreted as demonstrating "acceptance criteria" even if not explicitly labeled as such in the text.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

Study Information (where applicable)

1. Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of performance metrics for an AI/diagnostic device. The submission refers to measurement of properties. The provenance of the data (e.g., country of origin, retrospective/prospective) is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic devices (e.g., expert consensus on image findings) is not relevant for this material science submission. Performance is based on physical and chemical properties measured in a lab.

3. Adjudication method for the test set: Not applicable. Performance is based on direct measurements of material properties, not subjective assessment requiring adjudication.

4. 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 cement, not a diagnostic AI device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental cement.

6. The type of ground truth used: For physical and chemical properties (depth of cure, unpolymerized layer thickness, ambient light sensitivity), the "ground truth" would be the direct, quantitative measurements obtained via laboratory testing following ISO standards (specifically ISO 4049:2000). For safety and composition, the "ground truth" is the established safety profile of the identical ingredients used in predicate devices.

7. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of material science submission.

8. How the ground truth for the training set was established: Not applicable.

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CLEARFIL SE BOND PLUS is indicated for the following applications:

1. Direct restorations using light-cured composite resin or compomer
2. Cavity sealing as a pretreatment for indirect restorations
3. Treatment of hypersensitive and/or exposed root surfaces
4. Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics or composite resin using light cured composite resin
5. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
6. Core build-ups using light- or dual-cured composite resin
7. Cavity sealing under amalgam restorations

CLEARFIL SE BOND PLUS is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. This device consists of the primer, the bond and the accessories, and is substantially equivalent in design to CLEARFIL SE BOND.

The provided text describes the submission of a 510(k) premarket notification for a dental adhesive system called "CLEARFIL SE BOND PLUS". The submission aims to establish substantial equivalence to predicate devices, rather than proving the device meets specific acceptance criteria in a study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a diagnostic AI device is not available in this document.

However, I can extract information related to the device's properties and comparisons to predicate devices, which serve as a form of "acceptance criteria" in the context of a 510(k) submission for a non-AI 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 specify a "test set" in the context of an AI study. For the evaluated properties (biocompatibility, mechanical properties, physical properties), the specific sample sizes used for testing are not provided. The data provenance is described as being generated from various tests performed by Kuraray Medical Inc. and compared against their own and other manufacturers' predicate devices. The country of origin of the data would be Japan, where Kuraray Medical Inc. is based. The studies would be considered prospective for the "CLEARFIL SE BOND PLUS" device, as they were conducted to support its 510(k) submission.

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

This information is not applicable. The document describes laboratory-based testing of material properties, not an evaluation requiring expert consensus on a test set to establish ground truth in an AI/diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable. There was no adjudication method described as it pertains to expert reviews of a test set, which is common in AI studies.

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

No. This is a submission for a dental adhesive system, not an AI or diagnostic device that would involve human readers or MRMC studies.

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

No. This document does not describe an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established scientific standards and methods for evaluating biomaterial properties (e.g., ISO standards for biocompatibility), and comparative performance against legally marketed predicate devices. For bond strength and physical properties, the "ground truth" is derived from quantitative measurements obtained through standardized laboratory tests.

8. The Sample Size for the Training Set

This information is not applicable, as this is not an AI/machine learning device. The term "training set" is not relevant here.

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

This information is not applicable, as this is not an AI/machine learning device.

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