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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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PANAVIA F is indicated for the following applications:

• Cementation of metal crowns and bridges, inlays and onlays. 1)
• Cementation of porcelain crowns, inlays, onlays and veneers. 2)
• Cementation of composite resin crowns, inlays and onlays 3)
• Cementation of adhesion bridges and splints 4)
• Cementation of metal cores and prefabrication posts 5)
• 6. Bonded amalgam restorations

PANAVIA F 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.

This 510(k) summary is for a change of ownership and address for an already cleared device, PANAVIA F. It is not a submission for a new device requiring performance testing against acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this specific 510(k) submission.

The document states: "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes."

The FDA's response confirms that they have reviewed the notification and determined the device is "substantially equivalent" to legally marketed predicate devices, which is the standard for 510(k) clearances, especially for administrative changes like this.

In summary, there is no performance study or acceptance criteria analysis presented in these documents because the submission is for an administrative change, not a new device or significant modification requiring new performance data.

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PANAVIA F is indicated for the following applications:
Cementation of metal crowns and bridges, inlays and onlays.
Cementation of porcelain crowns, inlays and onlays.
Cementation of to composite resin crowns, inlays and onlays
Cementation of adhesion bridges and splints
Cementation of metal cores and prefabrication posts
Bonded amalgam restorations

PANAVIA F 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 crowns or bridges.
PANAVIA F is a resin based cement cured chemically and by visible light activation, and the improved device of PANAVIA 21. There are two major improvements; the curing method and introduction of the metal adhesion primer (ALLOY PRIMER, K974089).
This device consists of Paste (A and B pastes), ED Primer (Liquids A and B), ALLOY PRIMER, Oxyguard II, and accessories.

This is a 510(k) premarket notification for a dental adhesive device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific metrics is not available in the provided text.

The document discusses the substantial equivalence of the "PANAVIA F" dental cement to predicate devices already on the market. The "acceptance criteria" in this context refer to the regulatory requirements for showing the new device is as safe and effective as existing ones, rather than performance metrics for an AI algorithm.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of an AI/ML device. The document states "These modifications do not affect the safety and effectiveness" of PANAVIA F compared to PANAVIA 21. The "performance" is implicitly tied to its intended use for cementation of dental devices.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to a medical device's components and intended use, not a test set for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable.

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

The core argument for the device's acceptance is its "substantial equivalence" to legally marketed predicate devices, meaning it shares similar design, composition, function, and intended use, and that any modifications do not negatively impact its safety and effectiveness.

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