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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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This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges.

This product includes Porcelain Powder, Stain/Glaze and Blending liquid. The porcelain powder is composed of silica (SiOz), alumina (AlzOs), potassium oxide (K2O), sodium oxide (Na2O), boron trioxide (B2O3), calcium oxide (CaO), barium oxide (BaO), zirconia (ZrO2), zinc oxide (ZnO) , lithium oxide (Li₂O), tin oxide (SnO₂), magnesium oxide (MgO), Yttrium oxide (Y2O3) and terbium oxide (Tb2Os).. The blending liquid is composed of purified water, 1, 3-butanediol and diethanolamine. The Stain/Glaze is composed of the porcelain powder and the blending liquid in accordance with the mass ratio of 1:1.

The provided text describes a 510(k) premarket notification for a "Dental Porcelain Powder" device and outlines its acceptance criteria and non-clinical testing results. It does not describe an AI/ML powered medical device, an imaging device, or a study involving human readers. Therefore, many of the requested categories are not applicable to this document.

However, I can extract and present the information that is relevant to the acceptance criteria and non-clinical testing of this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML-powered or imaging device, the following categories are not applicable to the provided document. The device is a "Dental Porcelain Powder" and the testing described is non-clinical bench testing and biocompatibility testing.

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 for this type of non-clinical, bench testing. The document does not specify sample sizes for individual tests but rather the acceptance criteria for material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by standardized testing methods, not expert consensus in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) 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: Not applicable. No AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth for the non-clinical tests is based on the specified physical, chemical, and biological properties as defined by relevant ISO standards and product technical requirements.
8. The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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