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XT stain/glaze are glazing porcelains used to color staining and glazing of the surfaces of dental ceramic restorations,such as glass ceramic or zirconia-based ceramic.

XT stain/glaze includes glaze powder,glaze liquid,stain glaze,glaze spray. Glaze powder is composed primarily of SiO2,with components of B2O3,Al2O3, Na2O,K2O,Li2O, other oxides,and color additives. Glaze liquid is composed of deionized water and organic solvents. Stain glaze is mixed with glaze powder and glaze liquid,which can help dental professionals save the mixing process.It is in the form of a paste and applied to dental ceramic restoration surfaces by brushing.Glaze powder has 17 colors; therefore, glaze paste also has 17 colors. Glaze spray consists of glaze powder(Transparent-Glaze),organic solvent,deionized water, and Non-CFC propellant.It is supplied to dental professionals in the form of an aerosol can and applied to dental ceramic restoration surfaces by spraying. Glaze spray and stain glaze require the firing of the dental ceramic restorations after application of the glaze. During the firing process, the organic solvent and deionized water burn without being included in the dental ceramic restorations. Therefore, the final chemical composition of the dental ceramic restorations is the glaze powder.

The provided document is a 510(k) Premarket Notification from the FDA for a dental product called "XT Stain/Glaze". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for showing an AI medical device meets specific performance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI-powered device, the specifics of a study proving such criteria are met, sample sizes for test/training sets, expert qualifications, or details of MRMC studies.

The document focuses on:

• Device Description: XT Stain/Glaze is a dental material (porcelain powder, liquid, paste, spray) used for coloring, staining, and glazing dental ceramic restorations.
• Substantial Equivalence: Comparing the subject device (XT Stain/Glaze) to predicate devices (K181167 and K202629) based on indications for use, form, application, composition, sterility, type of dental ceramic, packaging, shelf life, physical properties, and biocompatibility.
• Non-Clinical Performance Data: Mentioning tests conducted like heavy metal testing (USP 43-NF 38:2020), other performance testing (ISO 6872), biocompatibility assessment (ISO 10993 series), transport and package testing (ISTA 3A), and shelf life evaluation (ASTM F1980).
• No Clinical Performance Data: Explicitly states, "No data from human clinical studies has been included to support the substantial equivalence of the subject device, XT stain/glaze."

In summary, this document is a regulatory submission for a dental material, not an AI medical device. Thus, it does not provide the details required to answer your specific questions regarding AI device acceptance criteria and study data.

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Glass Ceramic are indicated for fabricating all-ceramic restorations such as veneers, inlays, onlays, crowns, 2-unit anterior bridges, using the CAD/CAM system.

Glass Ceramic is indicated for fabricating all ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system.

The Glass Ceramic is composed of SiO2, Li2O, K2O, P2O5, Al2O3 and other oxides, the performance of the Glass Ceramic conforms to ISO 6872: 2015 Dentistry: Ceramic Materials.

The Glass Ceramic is disposable device, and provided as non-sterile.

The provided text describes a 510(k) premarket notification for a dental Glass Ceramic device and outlines non-clinical tests conducted to demonstrate substantial equivalence to a predicate device. It does not contain information about a study involving human readers, AI assistance, or expert ground truth for image analysis.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on the ISO 6872:2015 standard for Dentistry: Ceramic Materials and relevant ISO 10993 standards for biological evaluation.

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of non-clinical tests to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The results are summarized in Section 7 and further detailed in the comparison tables (Table 5-2 for Performance and Table 5-3 for Biocompatibility).

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not specify the exact sample sizes (e.g., number of test specimens) used for each non-clinical test. It only states that "Non clinical tests were conducted".
• Data Provenance: The tests were conducted by the manufacturer, Shenzhen Xiangtong Co.,Ltd., in China, as implied by their address and the submission origin. The tests are non-clinical, so "retrospective or prospective" doesn't directly apply in the human data sense. It refers to laboratory testing of material properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable as the document describes non-clinical material testing, not a study involving human interpretation or ground truth establishment by medical experts for diagnostic purposes. The "ground truth" for these tests is defined by the objective measurement standards outlined in the ISO standards.

4. Adjudication Method for the Test Set

This section is not applicable as the document describes non-clinical material testing, not a study involving human interpretation or adjudication processes.

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

There was no MRMC comparative effectiveness study done. The device is a dental material (Glass Ceramic) used for restorations, not an AI-assisted diagnostic or imaging device.

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

This section is not applicable as the device is a physical material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical tests was established by objective measurement against the specified criteria and methodologies detailed in the referenced ISO standards (e.g., ISO 6872 for ceramic materials, ISO 10993 for biological evaluation). These standards define acceptable ranges and test methods for properties like biaxial flexure strength, chemical solubility, and biocompatibility.

8. The sample size for the training set

This section is not applicable. The document describes the testing of a manufactured material, not a machine learning model that requires a training set.

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

This section is not applicable for the same reason as above.

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