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BegoStar is a precious dental casting alloy to make metal fused to ceramic dental restorations
Pontorex G is a precious dental casting alloy to make crown and bridge dental restorations
Platinlloyd KF is a precious dental casting alloy to make metal fused to ceramic dental restorations
Bio Platinilloyd is a precious dental casung alloy to make metal fused to ceramic dental restorations
Begopal S is a precious dental casting alloy to make metal fused to ceramic dental restorations
Begorex 45 is a precious dental casting alloy to make metal fused to ccramic dental restorations
PontoStar Ti is a precious dental casting alloy to make metal fused to ceramic dental restorations
Pontolloyd G is a precious dental casting alloy to make metal fused to ceramic dental restorations
Bio Pontostar XL is a precious dental casting alloy to make metal fused to ceramic dental restorations
Begolloyd 60 is a precious dental casting alloy to make crown and bridge dental restorations
Begolloyd PF is a precious dental casting alloy to make crown and bridge dental restorations
PontoStar G is a precious dental casting alloy to make metal fused to ceramic dental restorations
Gold EWL H is a precious dental casting alloy to make crown and bridge dental restorations
Platinlloyd M is a precious dental casting alloy to make crown and bridge dental restorations
Begopal 300 is a precious dental casting alloy to make metal fused to ceramic dental restorations
Begostar LFC is a precious dental casting alloy to make metal fused to ceramic dental restorations

Gold Dental Casting Alloys

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document appears to be a series of FDA 510(k) forms for various dental casting alloys, primarily indicating their names and intended uses. It confirms that these devices have been found substantially equivalent to predicate devices. There is no mention of any clinical trials, performance metrics, or study designs in the given text.

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Wirobond C is a non-Precious dental casting alloy to make full crowns and copings for porcelain fused to metal dental restorations.

Wirobond C is a non-Precious dental casting alloy.

The provided document is a 510(k) clearance letter from the FDA for a dental alloy, Wirobond C. It does not contain any information about acceptance criteria, device performance studies, or AI/software algorithm assessments.

Therefore, I cannot provide a response to your request, as the necessary information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details is completely absent from the provided text.

This document is solely focused on the regulatory clearance of a physical medical device (dental alloy) and confirms its substantial equivalence to a predicate device.

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BegoCer G is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in Degood of is a crown and enegal Class Ha according to Annex IX.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental alloy named BegoCer® G. It confirms that the device is substantially equivalent to a legally marketed predicate device.

Based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria.

The document is a clearance letter, which means the device has already gone through the review process and been deemed substantially equivalent. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be part of a submission to demonstrate safety and effectiveness.

Here's what can be inferred/answered based solely on the provided text, and what cannot be answered:

Information from the document:

• Device Name: BegoCer® G
• Device Type: Crown and bridge metal to ceramic type 4 alloy.
• Regulatory Class: Class IIa (according to Annex IX) / Class II (as stated by FDA in the letter).
• Indications For Use: "BegoCer G is a crown and bridge metal to ceramic type 4 alloy. It is a medical device..." (The rest of the sentence is cut off in the image but the core indication is clear).
• 510(k) Number: K983082
• Date of Clearance: October 28, 1998
• Manufacturer: BEGO U.S.A., Incorporated

Information NOT present in the document:

The provided text does not contain any information regarding:

1. A table of acceptance criteria and the reported device performance. This is a clearance letter, not the study report itself.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size. This type of study is more common for diagnostic imaging AI, not for a dental alloy's mechanical properties.
6. If a standalone performance study was done.
7. The type of ground truth used. (e.g., expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set. (Dental alloys typically don't involve "training sets" in the AI sense; their performance is evaluated through material science testing.)
9. How the ground truth for the training set was established.

Conclusion:

The provided FDA 510(k) clearance letter indicates that the BegoCer® G device was found substantially equivalent to a predicate device. However, it does not include the detailed study information, acceptance criteria, or performance data that would have been part of the original 510(k) submission. To answer the specific questions about acceptance criteria and study details, one would need to review the original 510(k) submission (K983082), which is not provided here.

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PlatinLloyd 100 is a crown and bridge type 4 casting alloy. It is a medical device in accordance with Regulation 95712 BBC. Guarder segulaiton requirements are met.

AuroLloyd KF

The provided FDA 510(k) clearance letter and associated documents for the "AuroLloyd® KF" device (K983080) do not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The documents indicate that the device, "PlatinLloyd 100," is a crown and bridge type 4 casting alloy and is being cleared based on its substantial equivalence to a legally marketed predicate device. The clearance is based on the device meeting CE seal requirements in accordance with Regulation 957/2 BBC (which seems to be a European regulation, potentially 93/42/EEC concerning medical devices or a similar standard, given the context of "Annex IX and CE seal").

Therefore, I cannot provide the requested information as it is not present in the given text. The FDA 510(k) process for substantial equivalence often relies heavily on comparison to an existing predicate device rather than demanding new clinical trials with detailed performance criteria and statistical studies for certain classes of devices, especially materials like dental alloys.

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PlatinLloyd 100 is : crown and bridge type 4 casting alloy. It is a medical device in PlatinLloyd 100 is ? Crown and online components to Annex IX. The CE seal accordance with Regulation 93/42 EEC. Class IIa according to Annex IX. The CE seal accordance with Regulation 75/42 BEO. Class and were and

Not Found

"1. A table of acceptance criteria and the reported device performance": "The provided document is a 510(k) clearance letter for a medical device (PlatinLloyd 100) and an 'Indications For Use' statement. It does not contain information about acceptance criteria or a study demonstrating device performance. The letter simply states the device is substantially equivalent to legally marketed predicate devices.",
"2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)": "This information is not available in the provided document.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)": "This information is not available in the provided document. The submission is a 510(k) for a casting alloy, not an AI or diagnostic device that typically involves expert ground truth for performance evaluation.",
"4. Adjudication method (e.g., 2+1, 3+1, none) for the test set": "This information is not available in the provided document.",
"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": "This information is not available in the provided document. The device is a casting alloy, not an AI-powered diagnostic tool.",
"6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done": "This information is not available in the provided document. The device is a casting alloy, not an AI or algorithmic device.",
"7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)": "This information is not available in the provided document.",
"8. The sample size for the training set": "This information is not available in the provided document. The submission is for a casting alloy, which typically doesn't involve training sets in the AI sense.",
"9. How the ground truth for the training set was established": "This information is not available in the provided document."
}

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Bio PontoStar is a metal to ceramic type 4 alloy. I is a medical device in accordance with Regulation 93/42 EEC. Class Iia according to Annex IX.

Bio PontoStar is a metal to ceramic type 4 alloy.

This document is a marketing authorization letter from the FDA for a dental alloy device (Bio PontoStar). It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

Therefore, I cannot answer your request based on the provided text. The document confirms that the device is "substantially equivalent" to previously marketed devices, allowing it to be sold, but it does not detail the technical performance evaluations.

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BegoPal is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with 93/42 EEC. Class IIa according to Annex IX.

BegoPal is a crown and bridge metal to ceramic type 4 alloy.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that demonstrates a device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental alloy named BegoPal, indicating its substantial equivalence to a predicate device. It discusses regulatory matters such as classification, general controls, and marketing authorization.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided text.

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