Search Results

Ask a specific question about this device

Fabrication of Dental Crowns, Bridges, Inlays and Cast Partial-denture Frames.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding a dental material called "Aurofluid M." This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to existing devices, not on performance studies or acceptance criteria for a new device's performance.

Ask a specific question about this device

Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and Implant-supported Prosthesis Substructures.

Not Found

The provided text is an FDA 510(k) clearance letter for a dental alloy, V-Delta Special, indicating its substantial equivalence to a predicate device. This type of document does not contain the detailed study information or acceptance criteria requested in your prompt.

The 510(k) clearance process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, that it does not raise different questions of safety and effectiveness. It typically relies on comparisons to existing devices and performance testing (which may or may not be detailed in the public summary).

Therefore, I cannot provide the information you requested based solely on the text provided. To answer your questions, I would need a different type of document, such as a clinical study report, a comprehensive premarket notification summary (510(k) summary), or an equivalent regulatory submission that details device performance and study methodology for a medical device that has undergone extensive testing.

In summary, the provided document does not contain the information needed to answer your questions regarding acceptance criteria, study details, ground truth, or expert involvement.

Ask a specific question about this device

Fabrication of Dental Crowns, Bridges, Inlays and Low-fusing Porcelain-fused-to-metal Applications.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental device named "Pagalinor 4". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets specific criteria.

The letter focuses on regulatory approval based on "substantial equivalence" rather than specific performance data from a clinical or technical study designed to evaluate and report against detailed acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The document is a regulatory approval notice, not a study report.

Ask a specific question about this device

Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy named "V-Supragold." It confirms substantial equivalence and allows the marketing of the device.

This document does not contain information about:

• Acceptance criteria and reported device performance in a numerical table.
• Details of a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set specifics).

Therefore, I cannot fulfill your request for this specific information based on the text provided.

Ask a specific question about this device

Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and Implant-supported Prosthesis Substructures.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental device, "V-Supra Plus," and an "Indications for Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.

Therefore, I cannot populate the table or answer the questions based on the provided text. This document is purely regulatory in nature, indicating that the device has been deemed "substantially equivalent" to predicate devices and can be marketed. It does not include the technical study results or performance metrics you are asking for.

Ask a specific question about this device

For use in the Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges and Implant-supported Prosthesis Substructures.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental alloy, Deltapal. It confirms the device's substantial equivalence to a legally marketed predicate device.

The document does not contain information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

This document is a regulatory approval letter for a physical material (dental alloy), not a software or AI-driven diagnostic device. Therefore, the types of detailed performance studies and criteria you're asking for are not typically included in such an FDA clearance letter for this kind of product.

Ask a specific question about this device

For Use in the Fabrication of Dental Crowns, Bridges, Inlays and Onlays.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental product called "Aurofluid CPF". This document primarily focuses on regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given text.

Ask a specific question about this device

For Enhancement of Porcelain Bond and Color in Porcelain-Fused-to-Metal Dental Crowns and Bridges.

Not Found

This document is a 510(k) clearance letter for a dental device, specifically "Aurofilm 2000" for "Enhancement of Porcelain Bond and Color in Porcelain Fused-to-Metal Dental Crowns and Bridges." It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The letter from the FDA to Metalor Dental USA Corporation confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It discusses regulatory classifications and general controls but does not delve into the specifics of a study proving the device meets performance acceptance criteria.

Therefore, I cannot provide the requested information based on the given document.

Ask a specific question about this device

For use in the Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.

Not Found

The provided documents are a 510(k) premarket notification letter from the FDA regarding a dental device called "V-Delta 450" and its indications for use. This type of document does not contain information about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The documents primarily confirm the substantial equivalence of the device to a predicate device and approve its marketing, outlining regulatory compliance requirements.

Ask a specific question about this device