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OPC Low Wear Opaque Porcelain is a porcelain powder, which will be bonded to metal copings to form dental restorations. Subsequent layers of translucent porcelains will be fired on top to complete the restoration. Particularly, to be used with OPC Low Wear Porcelain, K982377 to cover the metal restoration.

OPC Low Wear Opaque Porcelain will be used for porcelain-fused to metal restorations on high expansion alloys by or on the order of a dentist. OPC Low Wear Opaque Porcelain contains opacifiers to cover the metal on porcelain-fused to metal restorations. OPC Low Wear Opaque Porcelain is to be used on patients in a dentist office environment.

I apologize, but the provided text from K993249 does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a premarket notification (510(k) summary and FDA decision letter) for a dental porcelain product (OPC Low Wear Opaque Porcelain). Its purpose is to demonstrate substantial equivalence to previously approved devices, not to present a detailed study on device performance against specific acceptance criteria.

The 510(k) summary states:

• "We believe that OPC Low Wear Porcelain, K982377, and Synspar Porcelain, K910303, which have previously been approved by the FDA, are substantially equivalent."
• "The safety and effectiveness is not affected because OPC Low Wear Opaque Porcelain only differs from the predicate devices by adding opacifiers to hide the metal of the restorations and Zinc Oxide help achieve adequate bond to the metal."

This indicates that the manufacturer's claim of safety and effectiveness rests on the substantial equivalence to predicate devices, rather than on independent studies demonstrating performance against novel acceptance criteria.

Therefore, I cannot provide the requested table or information as it is not present in the given text.

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Gold Core 55 is a Type IV, high noble, yellow alloy to be used for inlays, onlays, single crown briges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indirect restorative composites. Particularly, OPC Low Wear, K982377, Jeneric/Pentron, which is a low temperature ceramic.

Gold Core 55 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, brugos, imposites, implant superstructures, substrate for medium expansion lower fusing porcelains me menter resear porcelain. The chemical composition of Gold Core 55 is as follows: Au - 55% Ag - 29% Pd - 10% Balance Amounts of: In, Sn, Zn, Ir

The provided document is a 510(k) summary for a dental alloy named "Gold Core 55." It describes the device's composition and intended use, and states that it is substantially equivalent to a previously cleared device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a study proving the device meets acceptance criteria.

The document is purely administrative, confirming the FDA's review and clearance for marketing based on substantial equivalence to a predicate device. It does not include any performance data or study results.

Therefore, I cannot provide the requested information from the given text.

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Gold Core 75 is a, high noble, yellow alloy, to be used for inlays, onlays, single crown bridges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indicret restorative composites. Particularly, OPC Low Wear, K982377, Jeneric/Pentron, which is a low temperature ceramic.

Gold Core 75 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridges, implant superstructures, substrate for medium expansion lower fusing porcelains and indirect restorative composites. Particularly to be used with OPC Low Wear, K982377, which is a low wear porcelain. The chemical composition of Gold Core 75 is as follows: Au - 75% Ag - 17% Pt-4.5% Rh - 0.5% Balance Amounts of: Zn, Ta, In, Ir

The provided text is a 510(k) summary for a dental alloy named "Gold Core 75". It states that the device is substantially equivalent to a previously marketed device, BIO74-PF Crown and Bridge Alloy (K943487). This type of submission (510(k)) focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with specific performance metrics and ground truth establishment as would be seen for novel or high-risk devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving device performance is not present in this document. The document primarily focuses on chemical composition and intended use to establish substantial equivalence.

Here's how the provided information relates to your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a study. The acceptance criterion for the 510(k) submission itself is "substantial equivalence" to a predicate device (BIO74-PF Crown and Bridge Alloy, K943487).
• Reported Device Performance: The document lists the chemical composition of Gold Core 75: Au - 75%, Ag - 17%, Pt - 4.5%, Rh - 0.5%, Balance (Zn, Ta, In, Ir). It also implicitly states its performance by declaring its intended uses (inlays, onlays, single crowns, bridges, implant superstructures, substrate for medium expansion lower fusing porcelains and indirect restorative composites). The basis of "performance" in this context is its chemical composition and intended use closely matching the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. The 510(k) does not describe a clinical study with a test set of data. Substantial equivalence is often based on material characterization and comparison to predicate device specifications.

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)

• Not applicable/Not provided. No test set requiring expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. No test set requiring adjudication is described.

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

• Not applicable/Not provided. This is a material (dental alloy), not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided. This is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided. No ground truth in the context of a clinical study is described. The "truth" for this submission is the established performance and characteristics of the predicate device.

8. The sample size for the training set

• Not applicable/Not provided. This is a material, not a machine learning model.

9. How the ground truth for the training set was established

• Not applicable/Not provided. This is a material, not a machine learning model.

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