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For use in prosthetic dentistry to create an all-ceramic prosthesis.

• Ceramic for coverage of a zirconia substructure
• Ceramic for coverage of a lithium disilicate substructure
  [CTE: 9.5~11.0×10-6/K (50-500°C)]

CERABIEN MiLai is a specific type of porcelain for dental restorations. The system consists of Powder, Paste and Liquids for powder/paste, to be applied utilizing layering technique and baked onto a ceramic frame of zirconia (ZrO2) or different lithium disilicate glasses.

The provided FDA 510(k) clearance letter pertains to CERABIEN MiLai, a porcelain powder for clinical use in prosthetic dentistry. The documentation focuses on demonstrating substantial equivalence to predicate devices through compliance with established international standards for dental ceramics.

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

The acceptance criteria are derived from the requirements of the recognized consensus standards ISO 6872:2015 and ISO 9693:2019. The reported device performance indicates compliance with these standards. Specific quantitative acceptance criteria or detailed device performance values (e.g., specific flexural strength values, CTE measurements) are not explicitly itemized in the document but are stated to have been met.

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

The document does not explicitly state the sample sizes used for the non-clinical tests (physical and mechanical tests, thermal shocking tests). It only indicates that "Physical and mechanical tests were conducted according to ISO 6872: 2015 and ISO 9693: 2019" and "the thermal shocking testing was conducted according to ISO 9693: 2019."
The provenance of the data (country of origin, retrospective/prospective) is not mentioned. However, since the applicant is Kuraray Noritake Dental Inc. located in Tokyo, Japan, it is reasonable to infer the testing was conducted either in Japan or under their direction.

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)

This is not applicable as the device is a material (porcelain powder) for dental prosthetics, not a diagnostic or screening device that requires expert interpretation for ground truth establishment. The performance is assessed through objective physical and mechanical tests based on recognized international standards.

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

This is not applicable for a physical material testing study. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or diagnostic agreement, which is not the case here.

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 is not applicable. MRMC studies are typically performed for AI or diagnostic imaging devices where human readers interpret medical images. The CERABIEN MiLai is a dental material, and its performance is evaluated through non-clinical physical and mechanical testing.

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

This is not applicable. The device is a material, not an algorithm. Its performance is inherent to its physical and chemical properties and is tested in a standalone manner against established standards without human-in-the-loop interaction in the performance evaluation.

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

For this type of device, the "ground truth" is established by the well-defined physical and mechanical requirements and test methods outlined in the recognized international standards ISO 6872:2015 and ISO 9693:2019. This includes objective measurements of properties like flexural strength and thermal compatibility, rather than subjective expert consensus or pathology.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

This is not applicable for the reasons mentioned in point 8.

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KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

KATANA Zirconia ONE For IMPLANT is used in combination with the TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE For IMPLANT cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

Compatible implant systems and TiBase are as follows.

The KATANA Zirconia ONE For IMPLANT mesostructure material (conforming to ISO 6872:2015) is a pre-sintered zirconia block to be used as the ceramic mesostructure component of a two-piece titanium base abutment. KATANA Zirconia ONE For IMPLANT is compatible with the specified TiBase and the CAD/CAM component of the Sirona Dental CAD/CAM system (K193408, K200191) as identified in the Indications for Use. This device is further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown.

The Zirconia block has identical composition as our own previously cleared reference device, KATANA Zirconia Block (K190436) under product code "EIH".

The mesostructure material of KATANA Zirconia ONE For IMPLANT is available in shades, A1, A2, A3, A3.5, B1, B2, C1, C2, D2 and NW for flexibility and application variety to meet individual patient needs. The mesostructure material of KATANA Zirconia ONE For IMPLANT is available with one block size and two sizes of access hole, which is small (S) and large (L).

The abutment must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component. PANAVIA SA Cement Universal (K183537) is used as the cement to set the mesostructure material to TiBase when the mesostructure material of the subject device set to TiBase prior to sterilization.

Dentsply Sirona has issued a letter of authorization indicating that the subject mesostructure material of the subject device can be selected in combination with the CAD/CAM system. Kuraray Noritake Dental and Dentsply Sirona have a business agreement for adding this new material to the Sirona CAD/CAM system. Kuraray Noritake Dental has worked with Dentsply Sirona to implement their new material into the Sirona CAD/CAM system libraries.

KATANA Zirconia ONE For IMPLANT which is the subject of this premarket notification consists of:

• Sirona Dental CAD/CAM System with CEREC Chairside Software or with inLab Software
• Sirona TiBase
• . KATANA Zirconia ONE mesostructured blocks

The provided text is a 510(k) summary for a dental device, specifically a zirconia block for implant mesostructures. It details the device's indications for use, design, material composition, and technical characteristics, comparing it to predicate and reference devices.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "test set" sample size for a clinical study. The performance evaluation relied on non-clinical testing and comparison to predicate devices, referencing international standards and scientific literature.

• Data Provenance: The document does not specify a country of origin for any data beyond the manufacturer being in Japan. The studies are non-clinical, involving material testing and compatibility assessments. There is no mention of retrospective or prospective data as no human clinical testing was performed.

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

Not applicable. No human clinical testing was performed, and thus no expert ground truth was established for a clinical test set. The ground truth for material properties and performance would be derived from adherence to international standards and non-clinical testing protocols.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set requiring human interpretation or adjudication was used, this information is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of the subject device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an AI algorithm. It is a physical dental material (zirconia block) used in a CAD/CAM system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance is related to the material's physical and mechanical properties, its compatibility with the CAD/CAM system, and its ability to meet structural requirements when fabricated into an abutment.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

• International Standards: Adherence to established ISO standards for ceramic dental materials (ISO 6872:2015) and dynamic fatigue testing for dental implants (ISO 14801:2016).
• Material Composition: Verification of identical chemical composition to a previously cleared reference device (KATANA Zirconia Block, K190436).
• Biocompatibility Standards: Evaluation against ISO 10993 series and ISO 7405.
• Engineering Design Parameters: Validation against specified design parameters for abutment post height, angulation, wall thickness, diameter, and gingival height, consistent with CAD/CAM system requirements and FDA recommendations.
• Compatibility: Confirmation of functional compatibility with the predicate CAD/CAM system (Dentsply Sirona) and associated TiBase components through a business agreement and technical specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a physical material, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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• [1] Direct restorations using light-cured composite resin
• [2] Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations
• [3] Treatment of exposed root surfaces
• [4] Treatment of hypersensitive teeth
• [5] Intraoral repairs of fractured restorations
• [6] Post cementation and core build-ups
• [7] Cementation of indirect restorations

CLEARFIL Universal Bond Quick 2 consists of BOND and K-ETCHANT Syringe. BOND is a light-cure bonding agent that allows for the treatment of dentin, enamel, and prosthetic materials. Depending on the indication, BOND is used as self-etching or with K-ETCHANT Syringe for selective enamel etching or total-etching procedures. BOND is intended to be used for both direct and indirect restorations. CLEARFIL DC Activator activates the dual-curing mechanism of BOND; however, the addition of CLEARFIL DC Activator to the adhesive is not required when using BOND with CLEARFIL DC CORE PLUS, self-adhesive resin cements manufactured by Kuraray Noritake Dental Inc. (Kuraray's self-adhesive cements, e.g. PANAVIA SA Cement Universal) or PANAVIA Veneer LC. K-ETCHANT Syringe is an etching gel that consists of 35 % phosphoric acid aqueous solution and colloidal silica.

This document is a 510(k) Premarket Notification from the FDA regarding a dental bonding agent, CLEARFIL Universal Bond Quick 2. It details the device's indications for use, its substantial equivalence to predicate devices, and the testing performed to demonstrate this equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria Table and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the sample sizes used for the shear/tensile bond strength or fluoride release testing. It states that "certain tests were performed on this device, in comparison with the primary predicate device..." and references "the results of comparative study."

Regarding data provenance: The applicant, Kuraray Noritake Dental Inc., is based in Japan (1621 Sakazu, Kurashiki, Okayama 710-0801, Japan). The testing appears to be in-house testing performed by the manufacturer to demonstrate substantial equivalence, rather than a large-scale clinical trial with specific regional data. The document mentions "in-house standard" for compliance. The data is retrospective in the sense that it represents a snapshot of the device's performance at the time of submission.

3. Number of Experts and Qualifications:

The document does not mention the use of experts to establish ground truth for a test set. This type of submission relies on physical and chemical performance testing against defined quantitative criteria (e.g., bond strength in MPa). There were no human studies (e.g., diagnostic studies) mentioned that would require expert adjudication.

4. Adjudication Method:

Not applicable. As described above, this submission focuses on objective laboratory performance metrics, not human-read subjective assessments that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted or mentioned. This is a dental bonding agent, not an AI-assisted diagnostic tool. Therefore, there's no concept of human readers improving with AI assistance.

6. Standalone Algorithm Performance:

Not applicable. This is a physical and chemical product, not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance evaluation is based on pre-defined quantitative performance metrics and physical/chemical properties established through laboratory testing. For example:

• Shear/Tensile Bond Strength: Measured values against a minimum acceptable MPa.
• Depth of Cure: Measured value against a minimum acceptable mm.
• pH: Measured value within a specified range.
• Appearance/Ease of Application/Occlusion of Dentinal Tubules: Qualitative assessment against defined criteria (e.g., "COMPLIES").

These are not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic or therapeutic clinical study, but rather engineering and material science specifications.

8. Sample Size for the Training Set:

Not applicable. This document describes a traditional medical device (dental material) and its performance validation, not a machine learning model that would require a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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Esthetic Colorant is used for coloring pre-sintered zirconia structures for the fabrication of all-ceramic restorations.

Esthetic Colorant, a colorant with a zirconia structure, is a dilute aqueous solution of transition metal salts and lanthanoid metal salts and enables appropriate color adjustment when combined with a pre-sintered zirconia structure such as KATANA Zirconia (K143439).

Esthetic Colorant colors the pre-sintered zirconia structure by applying it with a metal-free brush. The structure is then dried and then sintered at temperatures above 1400°C. Sintering welds the coloring components in Esthetic Colorant, making it possible to adjust the color shade of the zirconia structure.

Esthetic Colorant has 12 shades in bottle size (12 ml). In addition, Esthetic Colorant can only be used by professional technicians in the field of dentistry.

Here's a breakdown of the acceptance criteria and study information for the "Esthetic Colorant" device, based on the provided FDA 510(k) summary:

This document is a 510(k) summary for a medical device that colors pre-sintered zirconia structures for dental restorations. It is not an AI/ML device, and therefore several of the requested sections (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, sample size for training set, ground truth for training set) are not applicable.

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated how many samples were tested for each physical and chemical property, other than that the properties were evaluated according to ISO 6872:2015.
• Data Provenance: Not explicitly stated, but the company is in Japan (Kuraray Noritake Dental Inc.) so it can be inferred that the testing was conducted there. The testing is prospective as it's for a new product submission.

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 device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The ground truth refers to adherence to physical and chemical property standards.

4. Adjudication method for the test set

• Not Applicable. See point 3. Testing involves objective measurements against established ISO standards.

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 device, 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 a material science device; there is no algorithm or standalone performance in the context of AI.

7. The type of ground truth used

• International Standard Compliance: The ground truth is established by the requirements of the international standard ISO 6872:2015 for dental ceramics. This standard defines the acceptable ranges for physical (flexural strength, coefficient of thermal expansion) and chemical (chemical solubility) properties.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device with a training set.

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

• Not Applicable. See point 8.

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For use in prosthetic dentistry to create an all-ceramic prosthesis.

• Ceramic for coverage of a zirconia substructure
• Ceramic for coverage of a lithium disilicate substructure [CTE: 10.2-10.5×10-6/K (50-500°C)]

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a dental prosthetic material, CERABIEN MiLai. It does not contain any information about acceptance criteria for device performance, the study design, or results of any performance studies (e.g., clinical or technical validation studies for an AI/ML powered medical device).

Therefore, I cannot extract the requested information. The document pertains to the regulatory clearance of a material, not a software or AI device that would have such performance criteria and studies.

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Cementation of ceramic and composite inlays, onlays and laminate veneers with less than 2mm thickness

PANAVIA Veneer LC is a light-cure adhesive resin cement system. It consists of the light-cure cement paste (PANAVIA Veneer LC paste), CLEARFIL CERAMIC PRIMER PLUS, K-ETCHANT Syringe, and PANAVIA V5 Try-in Paste. CLEARFIL Universal Bond Quick or PANAVIA V5 Tooth Primer can be chosen for tooth treatment.

The cement paste is a light-cure, resin based material which provides color stability and has radiopacity equal to or greater than 1mm aluminum. It is indicated for inlays, onlays and laminate veneer restorations made of ceramic and composite resin. It is supplied in Kuraray's ergonomic syringe and dispensed via an angled applicator tip (16G) into an inlay cavity or onto an onlay or a laminate veneer. It is available in 4 shades; Universal (A2), Clear, Brown (A4) and White. It is classified as a Type 2 and Class 2 (Group 1) material by ISO 4049. Shade adaptation is available to check by PANAVIA V5 Try-in Paste before cementation. This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.

We are seeking clearance for PANAVIA Veneer LC paste in this submission.

Concerning Try-in Paste which is included as components of the PANAVIA V5, CLEARFIL Universal Bond Quick, CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe, the specification of those 4 components were omitted for the reasons set forth below.

We already have had 510(k) clearance of Try-in Paste of PANAVIA V5(510(k) Number: 150704), CLEARFIL Universal Bond Quick (510(k) Number: 161042), CLEARFIL CERAMIC PRIMER PLUS (510(k) Number: 150703) and K-ETCHANT Syringe (510(k) Number: 133078).

This document describes the marketing authorization for the PANAVIA Veneer LC dental cement. Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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For use in prosthetic dentistry to create a Porcelain prosthesis on a frame of dental alloy.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental porcelain product. It does not contain any information about acceptance criteria, device performance testing, sample sizes, expert qualifications, or study methodologies that would be required to answer your request.

Specifically, it lacks the following:

1. A table of acceptance criteria and reported device performance: This document only states the device "Noritake Super Porcelain EX-3" is cleared for "For use in prosthetic dentistry to create a Porcelain prosthesis on a frame of dental alloy." There are no performance metrics or criteria listed.
2. Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, or how training ground truth was established. The letter is a regulatory approval, not a scientific study report.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria as the document is a regulatory approval letter and does not contain the detailed study information you are asking for.

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CLEARFIL MAJESTY ES Flow is indicated for the following restorative applications:

• [1] Direct restorations for all cavity classes, cervical lesions (e.g. root surface caries, v-shape defects), tooth wear, and tooth erosion
• [2] Cavity base / liner
• [3] Correction of tooth position and tooth shape (e.g. diastema closure, tooth malformation)
• [4] Intraoral repair of fractured restorations
• [5] Cementation of ceramic and composite inlays, onlays and veneers with less than 2mm thickness

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental restorative material called CLEARFIL MAJESTY ES Flow. It details the device's indications for use and regulatory classification. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested information based on the given input text. The information typically found in a 510(k) clearance letter focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance study results and acceptance criteria. Such detailed study information would usually be found in the 510(k) submission itself or in published studies related to the device.

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• [1] Cleaning of contaminated glass ceramic, zirconia, resin restorations, metal restorations and fiber post after intraoral try-in.
• [2] Cleaning for contaminated prepared tooth (cavity, root canal and tooth abutment), and implant abutment

This subject device is a dental cleaning agent suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in.

It is also suitable for cleaning a contaminated prepared cavity, root canal, and tooth/ implant abutment. It is used in helping to achieve optimal adhesive results.

The provided text describes the regulatory clearance of a dental cleaning agent, KATANA Cleaner, by the FDA. It includes a 510(k) summary which details the device, its intended use, comparison to predicate and reference devices, and non-clinical performance testing.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

Summary of Device Performance against Criteria:

• Appearance and Coating Property: The device met in-house standards, showing no difference from predicate and reference devices.
• Shear Bond Strength: The device demonstrated "good performance as cleaning agent," with shear bond strengths "equal to or greater than those of the predicate device and the reference device" after contamination with artificial saliva. Specifically, for "Just after prepared" and "for 3 weeks at 70 ℃/ 158 °F," the shear bond strength was equal to the "Positive control (Without contamination and applying the subject device)" and higher than the "Negative control (without the subject device)."
• pH (before rinse/after rinse): The pH value of the subject device was within the range of the predicate and reference devices and became neutral after rinsing, similar to the control.
• Water Solubility: The device was easily removed from the substrate, indicating good water solubility.
• SEM and EDX Surface Comparison: The peak area ratio of the subject device was the same as the control, predicate, and reference devices.
• Staining Test: The device was confirmed to be colored (purple), similar to the predicate and reference devices.

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

• Sample Size: Not explicitly stated in the provided text for the individual bench tests. The text only mentions "Shear bond strength tests to the adherent surfaces were performed on this device..." and does not give the number of samples per test.
• Data Provenance: The studies were performance bench tests ("Non-Clinical Performance Testing"). There is no mention of country of origin of the data or whether it was retrospective or prospective, as these are in vitro laboratory tests. The submitter, Kuraray Noritake Dental Inc., is based in Japan.

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 as the evaluation involved non-clinical bench testing (material science / engineering properties) rather than human reader interpretation of medical images or clinical data. "Ground truth" in this context refers to the measured physical and chemical properties, not expert consensus.

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

• This information is not applicable as the evaluation involved non-clinical bench testing and not human interpretation or 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:

• This information is not applicable. This submission is for a dental cleaning agent, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance was not performed.

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

• This information is not applicable. This is a physical dental cleaning agent, not an algorithm.

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

• The "ground truth" for the non-clinical performance tests was established through measured physical and chemical properties, comparative analysis against controls (positive and negative), and comparison to predicate and reference devices. This includes:
  • Direct measurements of shear bond strength.
  • Visual inspection for appearance and coating property.
  • pH measurements.
  • Observation of water solubility.
  • Analytical techniques like Scanning Electron Microscopy (SEM) and Energy-Dispersive X-ray Spectroscopy (EDX) for surface comparison.
  • Biocompatibility testing according to ISO standards.

8. The sample size for the training set:

• This information is not applicable. This is a physical medical device, not a machine learning model; therefore, there is no "training set."

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

• This information is not applicable as there is no training set for this type of device submission.

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KATANA Zirconia Block is used for the fabrication of the ceramic restorations (frameworks, FCZ crowns, FCZ bridges (14Z L only), inlays, onlays and veneers).

The subject device, KATANA Zirconia Block is a pre-sintered zirconia block composed of yttrium stabilized zirconia, which is designed for CEREC milling systems. The subject device is meant to be end-user sintered after milling for the fabrication of dental restorations. KATANA Zirconia Block STML has 3 sizes (12Z, 14Z and 14Z L) and has 14 shade variations: (A1, A2, A3, A3.5, A4, B1, B2, B3, C1, C2, C3, D2, D3, NW). KATANA Zirconia Block ST has 1 size: (12Z) and has 1 shade variation: (CL). STML consists of 4 gradated shade layers and ST is mono color. They are classified as a Type II and Class 4a) material by ISO 6872.

This document describes the premarket notification for the KATANA Zirconia Block and demonstrates its substantial equivalence to previously cleared predicate and reference devices.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

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

The document provides a table (Table 3-6-3) comparing the subject device (KATANA Zirconia Block (14Z L)), the predicate device (KATANA Zirconia Block (12Z, 14Z)), and the reference device (KATANA Zirconia Disc (ST, STML)) against requirements specified in ISO 6872:2015 (Dentistry — Ceramic materials — Part 1: Dental ceramics).

"COMPLIES" indicates that the test value was within the acceptable range to pass the testing in compliance with the requirements of ISO 6872:2015.

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

The document does not explicitly state the sample sizes used for the bench testing. It refers to a "comparative study performed according to ISO 6872:2015," which typically involves specific sample sizes dictated by the standard for each test. The data provenance (country of origin, retrospective/prospective) is not mentioned. However, the applicant is "Kuraray Noritake Dental Inc." in Japan, suggesting the testing was likely conducted by or for this Japanese company.

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)

This is a physical/mechanical properties test for a dental ceramic block, not a diagnostic medical device that requires expert interpretation. Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth based on clinical evaluation. The ground truth for these tests is established by adhering to the standards and methods outlined in ISO 6872:2015. Visual inspections (e.g., for uniformity, absence of extraneous materials) would be performed by trained technicians or quality control personnel.

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

Since this is a bench testing scenario focusing on physical and chemical properties against a standard, an adjudication method for conflicting expert opinions (like 2+1 or 3+1) is not applicable. The compliance is determined by instrumental measurements and visual inspections against quantitative and qualitative criteria defined by ISO 6872:2015.

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

No MRMC comparative effectiveness study was performed. This device is a dental material (zirconia block) and not an AI-powered diagnostic tool requiring human reader assistance.

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

This is not an algorithm-based device. It is a physical dental material. Therefore, no standalone algorithm performance study was done. The performance evaluation is based on standard material testing methods.

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

The ground truth for this device's performance evaluation is established by international standards (ISO 6872:2015). The performance is measured against the pre-defined limits and specifications within this standard, rather than expert consensus on clinical cases, pathology, or outcomes data.

8. The sample size for the training set

This is not an AI/machine learning device; therefore, there is no "training set" in the computational sense. The material is manufactured and tested according to quality control procedures to meet the specified standards.

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

As there is no training set for an algorithm, this question is not applicable.

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