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Jelbond NP is a predominantly base alloy under ADA / ANSI and Identalloy classification system for dental alloy. It is designed for porcelain application and comaptible with most of the regular porcelains in the market. Jelbond NP is a Nickel-Chrome alloy for ceramic and acrylic veneering for crown and bridgework. It is Barylium, Boron and Aluminum free White color non-precious alloy. It's thermal coefficient of expansion corresponds to standard types of dental porcelains in the market.

Jelbond NP is a predominantly base alloy under ADA / ANSI and Identalloy classification system for dental alloy. It is designed for porcelain application and comaptible with most of the regular porcelains in the market. Jelbond NP is a Nickel-Chrome alloy for ceramic and acrylic veneering for crown and bridgework. It is Barylium, Boron and Aluminum free White color non-precious alloy. It's thermal coefficient of expansion corresponds to standard types of dental porcelains in the market.

The provided document is a 510(k) premarket notification letter from the FDA for a dental alloy named Jelbond NP. This type of document declares substantial equivalence to a predicate device and does not typically contain detailed information about specific acceptance criteria or comprehensive study results as would be found in a full clinical or performance study report.

Therefore, the following information cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics or acceptance criteria for the device beyond its classification as a predominantly base alloy.
2. Sample size used for the test set and the data provenance: No information about a test set or its provenance is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed ground truth establishment for a specific test set is not described.
4. Adjudication method 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: This is a material alloy, not an AI diagnostic device, so an MRMC study is not relevant and not discussed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a material alloy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a material alloy's 510(k) submission in this format.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

• Device Name: Jelbond NP
• Regulatory Class: II
• Product Code: EJH
• Indications for Use: Jelbond NP is a predominantly base alloy designed for porcelain application and compatible with most regular porcelains in the market. It is a Nickel-Chrome alloy for ceramic and acrylic veneering for crown and bridgework, and is Beryllium, Boron, and Aluminum-free. Its thermal coefficient of expansion corresponds to standard types of dental porcelains.
• Predicate Device: The letter states the device is "substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This implies that the performance of Jelbond NP is considered comparable to established predicate devices, rather than being proven through new, extensive clinical studies detailed in this specific document.
• Reviewing Office: Division of Dental, Infection Control, and General Hospital Devices, Office of Device Evaluation, Center for Devices and Radiological Health.

This document serves as a regulatory clearance based on substantial equivalence, not a detailed performance study report.

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