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Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis.

Antagon Porcelain is recommended for use with any normalfusing-temperature dental ceramic alloy.

After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Antagon Porcelain

I am sorry, but the provided text is a 510(k) premarket notification FDA letter which is a regulatory document. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

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Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses:

precious metal inlays, onlays, and crowns;

precious metal bridges, bars, and attachments;

precious metal copings and bridges for porcelain-fusedto-metal restorations.

Orion Vesta is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge.

After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Orion Vesta Dental Alloy

This document is an FDA 510(k) clearance letter for the Orion Vesta Dental Alloy. It does not contain the kind of detailed information about acceptance criteria, study design, or performance metrics that would be provided in a clinical study report or a more technical submission.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's why and what kind of document would contain this information:

• 510(k) Clearance Letter: This letter confirms that a device is substantially equivalent to a legally marketed predicate device. It doesn't typically delve into the specifics of performance testing beyond stating that the device meets its intended use.
• Acceptance Criteria & Performance: This information would be found in the "Performance Data" or "Non-Clinical Testing" sections of the 510(k) submission itself (which is not provided here), or in a specific study report for the device.
• Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): These are all elements of a detailed study design and results, which would be in a clinical or non-clinical study report and not summarized in the clearance letter.
• Training Set Information: This is relevant for AI/ML-based devices, which the Orion Vesta Dental Alloy (a physical dental material) is not.

To answer your request, I would need a document that describes the actual testing and validation performed on the Orion Vesta Dental Alloy, rather than just the FDA's clearance letter.

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Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses:

precious metal inlays, onlays, and crowns;

precious metal bridges, bars, and attachments;

precious metal copings and bridges for porcelain-fusedto-metal restorations.

Orion WX is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge.

After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Orion WX Dental Alloy

This document is a 510(k) premarket notification letter from the FDA regarding the Orion WX Dental Alloy. It confirms the device's substantial equivalence to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found for complex medical devices or AI algorithms. This is an approval letter for a dental alloy, which primarily relies on material properties and established clinical use, rather than performance metrics from a diagnostic study.

Therefore, I cannot provide the requested information in the table format or answer the questions related to studies, sample sizes, ground truth, or MRMC studies, as this type of information is not present in the provided text for this specific device.

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Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis. Carrara Porcelain and Carrara Vincent Porcelain are recommended for use only with Carrara and Cera E dental alloys. After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Carrara Porcelain and Carrara Vincent Porcelain

This is a 510(k) clearance letter for "Carrara Porcelain and Carrara Vincent Porcelain," dated May 15, 1998. The document does not contain any information regarding acceptance criteria or a study proving device performance.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means it met the regulatory standard at the time for marketing. It does not provide performance data from a clinical or non-clinical study to demonstrate specific acceptance criteria.

Therefore, for all the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for the training set), the answer is: Not applicable or not provided in the given document.

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Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, and attachments; precious metal copings and bridges for porcelain-fused-to-metal restorations. When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Cera E alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Cera E Dental Alloy

The provided document is a 510(k) clearance letter from the FDA for a dental alloy device (Cera E Dental Alloy). It states that the device is substantially equivalent to legally marketed predicate devices.

*However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or any other performance metrics typically associated with detailed device performance studies.

The letter is a regulatory approval, not a scientific study report. It focuses on:

• Substantial Equivalence: The primary basis for 510(k) clearance is demonstrating that a new device is "substantially equivalent" to a predicate device already on the market. This often means similar technological characteristics and indications for use, without raising new questions of safety and effectiveness.
• Intended Use Statement: The "Indications for Use" section (Page 3) describes how the device is intended to be used (e.g., by a dental lab technician for specific types of dental prostheses). This is a critical part of the regulatory submission.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance based on the provided text. The document simply doesn't contain that kind of information.

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Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal bridges, bars, and posts; precious metal copings, pontics and bridges for porcelain-fused-to-metal restorations. For porcelain-fused-to-metal restorations it is intended by the manufacturer that only normal-fusing-temperature porcelain products be used with the Biogold Plus alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Biogold Plus Dental Alloy

The provided document is a 510(k) premarket notification letter from the FDA regarding a dental alloy named "Biogold Plus Dental Alloy." This document does not contain any information about acceptance criteria or a study proving device performance. It is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

Therefore, I cannot fulfill your request for descriptions of:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in a study report or a different section of a 510(k) submission, and is not present in the provided FDA letter.

Ask a specific question about this device

Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, posts, and attachments; precious metal copings and bridges for porcelain-fused-to-metal restorations. When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Carrara alloys. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Not Found

This FDA 510(k) clearance letter (K980597) for "Carrara Dental Alloys" focuses on substantial equivalence to predicate devices and does not contain information on acceptance criteria or a study proving the device meets specific performance criteria. Therefore, I cannot provide the requested information based on the given document.

The document primarily states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects like general controls, classification, and labeling.

To answer your request, a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive test report, would be needed.

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