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Ceramic Etchant is intended for etching the porcelain veneers, crowns, and inlays extraorally. It is also used for pretreating the porcelain veneers, crowns, and inlays extraorally before bonding.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the Ceramic Etchant (HF-5 and HF-9) does not contain any information about acceptance criteria, device performance testing, or a study that proves the device meets specific criteria in the way described in your request.

The document is a standard FDA clearance letter confirming substantial equivalence to a predicate device. It discusses regulatory compliance, general controls, quality system regulations, adverse event reporting, and unique device identification. It also includes the "Indications for Use" for the Ceramic Etchant.

The information you are looking for, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details, would typically be found in the device's 510(k) summary or a more detailed biocompatibility/performance testing report submitted as part of the 510(k) application, not in the clearance letter itself.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices, which means the FDA has determined it is as safe and effective as a device already on the market. This determination is based on the information provided in the 510(k) submission, which is not fully detailed in this clearance letter.

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The device is indicated for fabrication of anterior and posterior dental restorations using different CAD/CAM or manual machines. All blanks are processed through dental laboratories or by dental professionals.

"Gradual Dental Zirconia Blank" is derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2 , Y2O3, HfO2 and other oxides. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.

"Gradual Dental Zirconia Blank" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.

"Gradual Dental Zirconia Blank" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of fifty different colors, gradual changing translucencies, and multi-layer aesthetic effect.

The different colors are originated from the different constituent of color additives (such as Fe2O3, Er2O3); the different translucencies are originated from small difference in the amount of Y2 O3, and the multilayer aesthetic effect is originated from the different padding method used in the process of dry pressing.

The provided document is a 510(k) summary for the "Gradual Dental Zirconia Blank" and does not describe an AI/ML device.

The content explicitly states:

• "Clinical Study is not performed for this device." (Section 5.11)
• The device is a "Gradual Dental Zirconia Blank" made from zirconia powder, used for fabricating dental restorations.
• The performance testing involved non-clinical bench testing per ISO 6872:2008 for properties like radioactivity, thermal expansion, chemical solubility, and flexural strength.

Therefore, the requested information regarding acceptance criteria and studies related to an AI/ML device, such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, cannot be extracted from this document as it pertains to a physical dental material, not an AI/ML software or system.

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"Glaze Paste, Glaze Powder, and Glaze Liquid" are 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.

"Glaze Paste, Glaze Powder, and Glaze Liquid" is a dental veneering material used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The intended use of general porcelain is to make the artificial teeth (dental prosthesis) more similar with natural teeth.

"Glaze Paste, Glaze Powder, and Glaze Liquid" are actually three products: Powder, paste, and liquid. "Glaze Powder" is in the form of a porcelain dry powder and liquid. When mixed together by the technician at a dental lab, they form the paste stain before applied to the patient.

"Glaze Paste" is pre-mixed paste from porcelain powder and liquid, which can help dental technicians save the mixing process.

The porcelain powder is composed primarily of SiO2, with minor components of Al2O3, K20, Na2O, Li2O, and color additives. The liquid is composed of deionized water and organic solvents. The liquid can also be used as a thinner to control viscosity of paste.

"Glaze Paste, Glaze Powder, and Glaze Liquid" are supplied in seventy one different colors, with or without fluorescence effect.

The provided text describes a 510(k) submission for a dental product (Glaze Paste, Glaze Powder, and Glaze Liquid), focusing on demonstrating substantial equivalence to a predicate device, not on proving that an AI/device meets specific clinical performance acceptance criteria. Therefore, most of the requested information regarding AI device acceptance criteria, study details, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.

However, I can extract the general acceptance criteria and performance data for the material itself, based on the regulatory standards mentioned.

Here's what can be extracted and what cannot:

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

The document states that "Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the 'Glaze Paste, Glaze Powder, and Glaze Liquid' met its specifications. All tests were verified to meet acceptance criteria." It also mentions "Biocompatibility testing was performed to verify the equivalence of the materials that are used."

The specific numerical acceptance criteria from ISO 6872:2015 are not explicitly listed in the document. However, the document does state that the device "conforms to ISO 6872, Dentistry, Ceramic Materials" and "test results met all relevant requirements in the test standard."

For biocompatibility, the document explicitly lists that the subject device's performance met the criteria of ISO 10993.

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

This information is not provided in the document. The document refers to "bench testing" and "biocompatibility testing" but does not specify sample sizes for these tests, nor the data provenance beyond "internal procedures."

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. This is a material testing conformity rather than an AI or diagnostic device that requires expert ground truth establishment for a test set.

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

Not applicable, as this pertained to material performance and biocompatibility testing, not an AI or diagnostic study requiring human adjudication of results.

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 or diagnostic device.

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

Not applicable. This is a material.

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

For material performance, the "ground truth" would be the chemical and physical properties as defined by the international standard ISO 6872:2015. For biocompatibility, the in vitro and in vivo test results against the criteria of ISO 10993 standards serve as the "ground truth."

8. The sample size for the training set

Not applicable. This is a material, not an AI model requiring a training set.

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

Not applicable.

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"Hyramic CAD/CAM Restorative" is used for dental restorations, such as full crowns, inlays/onlays and veneers.

"Hyramic CAD/CAM Restorative" consists of inorganic filler and polymer material to form a homogeneous solid block material. The inorganic filler is derived from glass powders, while the resin is derived from methacrylate co-polymer (UDMA,TEGDMA、 and BisGMA). The formed blocks have a microstructure of inorganic materials embedded in a highly cured resin matrix. The unique combination of the two materials creates a uniform hybrid, which lends the positive physical properties of each individual material to the other. The material has been processed through various molding techniques – into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of dental restorations such as full crowns, inlays/onlays and veneers. "Hyramic CAD/CAM Restorative" is hybrid ceramic/resin dental blanks designed for the manufacture of dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. Unlike conventional ceramic restorations, customization and glaze firing is not necessary for Hyramic CAD/CAM Restorative. "Hyramic CAD/CAM Restorative" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of twenty one different colors, two different translucencies, and two different aesthetic effects (single and multilayer).

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria, structured according to your requested information.

It's important to note that this document is a 510(k) Summary. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical efficacy studies akin to what might be required for a novel device or a PMA. Therefore, the information might not align perfectly with what one would expect for a complex AI/software medical device.

Key takeaway: This document describes a traditional dental material (Tooth Shade Resin Material) and not an AI or software device. As such, many of the questions related to AI-specific elements (like MRMC studies, AI improvement, standalone algorithm performance, training set details) are not applicable. The "device" here is a physical material for dental restorations.

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

Based on the document, the acceptance criteria are primarily derived from the ISO 10477 standard for "Dentistry - Polymer-based crown and bridge material." Specific numerical acceptance criteria are not explicitly listed in this summary, but the general statement is that "All tests were verified to meet acceptance criteria." and "results met all relevant requirements in the test standard."

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

The document does not specify the sample sizes used for the mechanical or biocompatibility tests. It also does not explicitly state the provenance of the data in terms of country of origin or whether it was retrospective or prospective, beyond stating that testing was performed. These are bench tests on material samples, not patient data.

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

This question is not applicable. The device is a physical dental material, and the "ground truth" for its performance is established through standardized laboratory testing (e.g., measuring flexural strength, water absorption), not by expert interpretation of data.

4. Adjudication method for the test set

This question is not applicable, as there's no expert interpretation or consensus involved in establishing the "ground truth" for material properties.

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

This question is not applicable. The device is a physical dental restoration material, not an AI or software algorithm that assists human readers.

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

This question is not applicable as the device is not an algorithm.

7. The type of ground truth used

The ground truth for the performance of the "Hyramic CAD/CAM Restorative" is established through standardized laboratory measurements and physical property testing as defined by ISO 10477 and ISO 10993. This is akin to "benchmark" data for material science, not clinical pathology or outcomes data.

8. The sample size for the training set

This question is not applicable. There is no concept of a "training set" for a physical dental material like this. The material is manufactured, and its properties are then tested.

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

This question is not applicable as there is no training set for this type of device.

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"Dental Zirconia Blank for Aesthetic Restoration" is mainly used in prosthetic treatment. When the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is between 300-500 MPa, the product can be used for veneering, inlay, single crown, and substructure ceramic for three-unit prostheses not involving molar restoration; when the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is over 500 MPa, it can be used for veneering, inlay, single crown, and substrate ceramic for three-unit prostheses. All blanks are processed through dental laboratories or by dental professionals.

"Dental Zirconia Blank for Aesthetic Restoration" is derived from zirconia powder that has been processed through various molding and sintering techniques – into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2 + Y2 O3 + HfO2+ Fe2O3+ Er2O3+ Al2O3. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.

"Dental Zirconia Blank for Aesthetic Restoration" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.

"Dental Zirconia Blank for Aesthetic Restoration" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of forty-six different colors, three different translucencies, and two different aesthetic effects (single and multilayer).

The different colors are originated from the different constituent of color additives (such as Fe203, Er202); the different translucencies are originated from small difference in the amount of Y2 O3, and the different aesthetic effects are originated from the different padding method used in the process of dry pressing.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Dental Zirconia Blank for Aesthetic Restoration":

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel acceptance criteria for a new type of device. The acceptance criteria are largely based on adherence to existing ISO standards for dental ceramic materials and biocompatibility.

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

• Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many specimens for flexural strength, how many animals for biocompatibility tests). It refers to "Bench testing" performed "per ISO 6872:2008 and internal procedures" and "Biocompatibility testing" performed "following the recommended procedures outlined in the FDA recognized consensus standard of ISO 10993." These ISO standards typically specify minimum sample sizes for material testing.
• Data Provenance: The studies were conducted by Liaoning Upcera Co., Ltd. for their "Dental Zirconia Blank for Aesthetic Restoration." The country of origin for the studies is implicitly China, as the submitter is based in Benxi, Liaoning, China. The studies are prospective in the sense that they were performed on the subject device to demonstrate compliance with standards and equivalence.

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

This information is not applicable and not provided in the document. The tests performed are objective, laboratory-based material characterization and biocompatibility assessments, not subjective evaluations requiring expert consensus for ground truth. The "ground truth" here is adherence to established international standards (ISO).

4. Adjudication method for the test set:

Not applicable. The tests are scientific measurements and biological evaluations, not requiring human 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 a material science and biocompatibility study for a dental restorative material, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a material science and biocompatibility study, not an algorithm.

7. The type of ground truth used:

The "ground truth" used for this device's acceptance is based on:

• International Standards: Primarily ISO 6872:2008 for ceramic materials and ISO 10993 series for biological evaluation of medical devices.
• Predicate Device Performance: The device's performance is explicitly compared against a legally marketed predicate device (K093560, "Upcera Zirconia Blanks") to establish substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no machine learning or AI component described in this device submission, so the concept of a "training set" is irrelevant.

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

Not applicable, as no training set is involved.

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Dental Lithium Disilicate Glass Ceramic Blocks (Up. Press Series and Up. CAD Series) 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.

Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series) are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, P205, Al2O3, B2O3, and other oxides. It also contains inorganic pigments (Er2O3, V2O3, and MnO2) to provide different shades on the product surface. The performance of this lithium silicate dental blank conforms to ISO 6872. Dentistry: Ceramic Materials

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets these criteria:

This document is a 510(k) Premarket Notification from the FDA regarding a dental product, not an AI/ML device. Therefore, many of the requested categories related to AI performance, such as test sets, ground truth establishment, MRMC studies, and training sets, are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies that demonstrate compliance.

Device: Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and UP. CAD Series)

Acceptance Criteria and Reported Device Performance

Studies Demonstrating Compliance:

• Bench Testing:

  • Standard: ISO 6872:2008 (Dentistry: Ceramic Materials).
  • Methodology: Performed according to the standard and internal procedures.
  • Results: "All tests were verified to meet acceptance criteria."
  • Goal: To ensure the Dental Lithium Disilicate Glass Ceramic Block met its specifications, particularly for mechanical properties like flexural strength. The subject device showed "higher flexural strength and potentially wider dental applications compared with predicate device."

• Biocompatibility Testing:

  • Standard: ISO 10993 series (FDA recognized consensus standard).
  • Specific Tests and Standards:
    • Cytotoxicity: ISO 10993-5:2009
    • Irritation Oral Mucosa Irritation: ISO 10993-10: 2010
    • Sensitization: ISO 10993-10: 2010
    • Subacute and Subchronic Toxicity: ISO 10993-11: 2006
    • Genotoxicity: ISO 10993-3: 2003
  • Results: "Results met all relevant requirements in the test standards, and are comparable to the predicate device." This means the device demonstrated no cytotoxic, irritant, sensitizing, subacute/subchronic toxic, or genotoxic effects.
  • Goal: To verify the equivalent safety of the materials used in the device.

Information not applicable to this device (as it's not an AI/ML device):

• Sample size used for the test set and the data provenance: Not applicable. Performance is based on material property testing, not a dataset of cases.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is based on standard material science measurements and biological assays, not expert interpretation of cases.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device involves established physical and chemical properties measured according to international standards (ISO). For biocompatibility, it's based on biological assay results aligning with ISO 10993 pass/fail criteria.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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Upcera Coloring Liquid (I and II) is a liquid used for the complete or partial coloration of milled Upcera zirconia substructure and anatomy before sintering.

Upcera Coloring Liquid (I and II) are water based coloring liquids, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth. Upcera Coloring Liquid I is provided in 21 different shades, and Upcera Coloring Liquid II is provided in 16 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures.

The provided text describes a 510(k) premarket notification for a medical device called "Upcera Coloring Liquid (I and II)". It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device.

The document is a submission to the FDA for a coloring liquid for dental zirconia, which is a material used in dental restorations. The "performance testing" described in Section 5.9 and Table 5.2 refers to biocompatibility testing of the coloring liquid itself, which is a standard requirement for materials that will be in contact with the human body, not a performance study of an AI device.

Therefore, I cannot provide the requested information about acceptance criteria and a study as the device described is not an AI/ML powered medical device.

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Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.

Upcera Dental Zirconia Blanks are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + Al2O3 with its composition conforms to ISO 13356, Implants for Surgery -- Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry: Ceramic Materials.

Upcera Dental Zirconia Pre-Shaded Blanks are derived from the same Zirconia powder as the regular Upcera Dental Zirconia Blanks, with the addition of very small amount of inorganic pigments, before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the pre-shaded dental zirconia blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials.

The document describes the submission of a 510(k) premarket notification for "Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank." The primary goal of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K093560, "Upcera Zirconia Blanks"). The acceptance criteria and the study used to demonstrate that the device meets these criteria are primarily based on international standards for dental materials.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the specified ISO standards, and the reported performance indicates compliance with these standards.

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