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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.

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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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