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Dental porcelain powder is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.

Dental porcelain powder is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure. Dental porcelain powder is composed of silicon oxide, aluminum oxide, boron oxide, potassium oxide, sodium oxide, magnesium oxide, calcium oxide, yttrium oxide, zirconium oxide, zinc oxide, strontium oxide, barium oxide, titanium oxide, titanium oxide, cerium oxide, vanadium oxide, bait oxide, praseodymium oxide, and other oxides, distilled water, 1,3-butylene glycol, 1,5-pentanediol, propanetriol, diethanolamine.

The product models are categorized into pastes (PAS), powders (POW) and liquids (LIQ) depending on the form of the product. Among them, pastes are made of powders and liquids.

The products are divided into different sizes according to the capacity of the different models.

The products are divided into different shades according to the different shades of the models of pastes (PAS) and powders (POW), and into different shades according to the strength of volatility of the products of the model of liquids (LIQ).

Dental porcelain powder is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the data, the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.

The provided text is a 510(k) Summary for a Dental porcelain powder (K242400). It describes the device, its intended use, and how it was determined to be substantially equivalent to a predicate device.

However, the document does not describe a study involving an AI/Machine Learning (ML) device or software. Instead, it focuses on the physical and chemical properties of a dental material. Therefore, most of the requested information regarding acceptance criteria and studies for AI/ML performance metrics (like sensitivity, specificity, MRMC studies, standalone performance, ground truth establishment, training set details) is not applicable to this submission.

The document states:

• "10. Clinical Performance Data: Not applicable. Clinical performance testing has not been performed for the subject device."
• "9. Summary of Non-Clinical Testing: Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the new device, Dental porcelain powders met its specifications."

Based on the information provided for this non-AI/ML medical device:

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance:

• The document does not specify the sample size used for the bench tests. It only states that tests were performed "per ISO 6872:2015 and internal procedures."
• Data provenance is not explicitly stated but implies laboratory testing data. It is not clinical data, nor does it specify country of origin for the test data itself (though the applicant is from China). The tests are non-clinical (bench).

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

• Not applicable. This is a material science study, not an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" is defined by the objective physical and chemical standards of ISO 6872:2015.

4. Adjudication method for the test set:

• Not applicable. Testing involves objective measurements against established standards, not subjective assessments requiring adjudication.

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. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• For the physical and chemical properties, the ground truth is established by the specifications and testing methodologies outlined in ISO 6872:2015 (Dentistry - Ceramic materials) and the manufacturer's internal final inspection criteria.
• For biocompatibility, the ground truth is established by the ISO 10993 standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context. Material formulation and process development would involve iterative testing, but this is developmental, not part of a formal AI/ML training dataset.

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

• Not applicable. As this is not an AI/ML device, there's no "training set" in the sense of labeled data for an algorithm. The development of the dental porcelain powder would follow material science principles and engineering specifications, where "ground truth" for material properties is derived from established scientific understanding and testing standards.

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Glass Ceramics are indicated for fabricating all-ceramic restorations such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.

Glass Ceramics contains glass ceramic blocks for dental use. The main ingredients of the product include Silica: 55%~65%: Lithium oxide: 12%~25%: Alumina: 2%~12%; Potassium oxide: 2%~14%; Other oxides: 0%~10%. Through the digital scanning of teeth or tooth mold, 3D data of tooth mold can be obtained. According to this data, CAD design can be carried out to design porcelain block processing model. Then, a CNC machine tool was used to manufacture the all-porcelain denture crown by CAM according to the porcelain block processing model. After air sintering or vacuum sintering, the all-porcelain denture was made to achieve the strength and aesthetic effect required by clinical use.

The provided text is a 510(k) Premarket Notification from the FDA regarding a dental device called "Glass Ceramics." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria related to an AI/Software as a Medical Device (SaMD) product.

Therefore, the requested information for an acceptance criteria table and a study proving a device meets these criteria (especially concerning AI/ML performance metrics like sensitivity, specificity, AUC, or reader improvement with AI assistance, sample sizes for AI training/test sets, expert ground truth establishment, etc.) cannot be extracted from this document, as it is about a material (dental glass ceramics) and not an AI/SaMD product.

The document discusses:

• Physical and Chemical Properties Tests: These are bench tests against standards like ISO 6872:2015 for properties like flexural strength, chemical solubility, coefficient of thermal expansion, and glass transition temperature.
• Biocompatibility Tests: These tests follow ISO 10993 standards for cytotoxicity, sensitization, irritation, systemic toxicity, subchronic toxicity, and genotoxicity.
• No Clinical Performance Data: The document explicitly states "Clinical performance testing has not been performed for the subject device."
• No mention of AI/ML: There is no indication that this device incorporates AI or machine learning.

Summary of why the requested information cannot be provided:

The input document describes a physical medical device (dental glass ceramics) and its FDA 510(k) clearance process, which relies on demonstrating substantial equivalence to an existing predicate device based on physical, chemical, and biocompatibility properties. It does not involve AI or software performance metrics, clinical studies with human readers, or ground truth establishment in the context of diagnostic or interpretive tasks.

To answer your prompt, I would need a document related to an AI/SaMD product, not a material science product.

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Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. All blocks are processed by dental laboratories or by dental professionals.

Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.

The provided text is an FDA 510(k) Premarket Notification for a dental product called "Zirconia Block." This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device for regulatory clearance. It does not present acceptance criteria for an AI/ML-based device or a study proving that an AI/ML device meets such criteria.

The document describes a physical product (Zirconia Block) used for dental restorations and details its composition, intended use, and physical/chemical properties, comparing them to a predicate device. The "Clinical Performance Data" section explicitly states "Not applicable. Clinical performance testing has not been performed for the subject device." This further confirms that no study was conducted to demonstrate clinical performance, and by extension, no study to prove an AI/ML device meets acceptance criteria.

Therefore, I cannot provide the requested information because the provided text pertains to a traditional medical device (Zirconia Block) and not an AI/ML-based device.

To answer your request, I would need a document describing an AI/ML-based medical device.

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