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Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material. It is indicated for use, in cured form, to restore carious lesions or structural defects or lost tooth structure either by itself or in combination of metal/ceramic/polymeric substrates and conditioners such as bonding, luting, etching agents commonly used in tooth restoration. The curing can be processed using photo and/or heat curing devices. The curing can accomplished in air, under vacuum or under pressure without or with inert atmosphere.

Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material.

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a 510(k) summary for a dental restorative material, Sculpture Plus Nano-Hybrid Composite, stating its substantial equivalence to a predicate device. It focuses on regulatory approval based on equivalence, not on performance studies with specific acceptance criteria as you've outlined.

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Gold Core Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains.

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Here's an analysis of the provided text regarding the acceptance criteria and study for the Gold Core Plus device:

Based on the provided K023499 510(k) summary for Gold Core Plus, the device is a dental alloy. The regulatory review process for this type of device, particularly in 2003, primarily focused on establishing substantial equivalence to a legally marketed predicate device rather than on performance against specific quantitative acceptance criteria demonstrated through clinical studies in the way you might see for software or more complex medical devices.

Therefore, many of the requested categories related to clinical study design, sample sizes, ground truth, and expert adjudication are not applicable to this submission. The "acceptance criteria" here are fundamentally about demonstrating that the new device is as safe and effective as the predicate device.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. The submission focuses on elemental composition comparison and general knowledge of material properties, not a test set of patient data or device performance data from a specific study.
• Data Provenance: Not applicable. The "data" here refers to the chemical composition of the alloys and historical use of Molybdenum, not clinical or performance data from a specific country or study type.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. Ground truth, in the context of clinical or diagnostic performance, is not established for this type of device submission. The FDA reviewers are experts in dental materials.
• Qualifications of Experts: The experts involved are the FDA reviewers from the Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, who review premarket notifications against existing regulations and scientific understanding of materials.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There is no "test set" in the context of a clinical performance study with adjudication. The evaluation is based on chemical composition and historical material use.

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

• MRMC Study: Not applicable. This is a material (dental alloy), not an AI-powered diagnostic or assistive device.

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

• Standalone Study: Not applicable. This is a dental alloy, not an algorithm.

7. The type of ground truth used

• Ground Truth Type: For this device, the "ground truth" for substantial equivalence is primarily based on:
  • Chemical Composition Analysis: Comparing the elemental makeup of the new device to the predicate.
  • Material Science Principles: Understanding how the addition of Molybdenum affects properties like corrosion resistance, and relying on established knowledge of Molybdenum's safe and effective use in similar alloys.
  • Regulatory Precedent: The predicate device (Jewel Cast II, K003039) having already been cleared by the FDA.

8. The sample size for the training set

• Sample Size: Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Ground Truth Establishment: Not applicable. No training set for a machine learning model is involved.

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Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crown, bridges,. implant superstructures and substrate for low fusing, high expansion porcelains and composites. .

Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crowns, bridges, implant superstructures and substrates for low fusing, high expansion porcelains and composites. Gold Core 35 is substantially equivalent to Gold Core 55, K993173 with the exception of a minor few elements. However, the addition of these elements does not affect safety and effectiveness.

This is a 510(k) summary for "Gold Core 35", a noble, yellow alloy used for dental restorations. The provided document does not contain information about acceptance criteria, device performance, a study, or any of the other specific details requested in your prompt (sample size, experts, adjudication, MRMC study, standalone performance, ground truth, training set).

The document is a regulatory approval letter from the FDA, stating that Gold Core 35 is substantially equivalent to a previously marketed predicate device (Gold Core 55, K993173). It focuses on regulatory compliance rather than presenting scientific or clinical study data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using the provided text. The requested information simply isn't present.

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Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites.

Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites. Jewel Cast Plus is substantially equivalent to Pentron Laboratory Technologies, LLC., Jewel Cast III with the exception of an element. However, addition of an element does not affect safety and effectiveness because it dramatically improves the corrosion resistance of the alloy. Also, Molybdenum has been used successfully in dental alloys for over 30 years.

This document is a 510(k) summary for a dental alloy, Jewel Cast Plus. It states that the device is substantially equivalent to a predicate device, Jewel Cast III, with the exception of an added element (Molybdenum) to improve corrosion resistance. However, it does not contain the detailed study information or acceptance criteria you've requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, ground truth establishment, or expert involvement in a study, as this information is not present in the provided text.

The text solely focuses on the substantial equivalence determination for a dental alloy based on its composition and an assertion regarding its improved corrosion resistance, rather than detailing a performance study with specific acceptance criteria.

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Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.

Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets them in the way typically expected for AI/software devices. The device, "Sonata Micro Hybrid Composite," is a dental restorative material, which is a physical product, not a software or AI device.

The provided text focuses on establishing substantial equivalence to existing predicate devices based on its intended use and material properties, rather than performance against specific acceptance criteria derived from a clinical or technical study as would be seen for AI/ML or diagnostic devices.

Therefore, I cannot extract the requested information from the provided text. The questions are designed for a different type of device and regulatory submission.

Specifically, for the reasons below, I cannot provide the requested table and details:

• No Acceptance Criteria or Performance Data: The document states the device is "substantially equivalent to Conquest Crystal, K932154 and other dental restorative resin composites on the market." This is the basis for its clearance, not a demonstration against predefined acceptance criteria from a specific study designed to measure performance metrics. The information is about the type of material and its intended use, not about a measurable performance outcome that could be compared to a benchmark.
• No "Study" in the AI/Software Sense: There is no mention of a study involving data sets, ground truth, experts, or statistical analysis of performance as would be relevant for an AI/ML device. The "study" here is implicitly a comparison of material properties and intended use to a predicate device.
• No AI/ML Component: The device is a physical dental composite. The questions regarding sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance are irrelevant to this type of product.

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