Search Results

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

DenMat Multilayered Zirconia Discs are made of Zirconium Oxide (Y-TZP ZrO2). For dental applications in accordance with ISO 6872, (DIN EN ISO 6872), this material is specially made for manufacturing of permanent and removable dental prosthetics. After completion of the final sintering, all DenMat Multilayered Zirconia meets the requirements of ISO 6872, Type II, Class 5. It is necessary to mill the disc with an appropriate enlargement factor to account for the shrinkage that occurs during full sintering. DenMat Zirconia Multilayered (ML) discs can be used with any compatible CAD/CAM machine.

Material Used:
DenMat Multilayered Zirconia Discs are composed of zirconia ceramics (ZrO2) based on yttria-stabilized tetragonal zirconia (Y-TZP). The material is biocompatible according to ISO 10993-1: 2018 "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"

The provided FDA 510(k) clearance letter and summary for the DenMat Multilayered Zirconia Disc do not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing AI assistance to human readers.

Instead, the document describes the physical and chemical properties of a dental material (zirconia discs) and compares them to a predicate device. The performance data presented are results from laboratory tests conducted on the material itself, not clinical studies involving human readers or AI algorithms for disease detection/diagnosis.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device clearance.

However, I can extract the acceptance criteria and performance data for the material's physical properties as presented in the document.

Acceptance Criteria and Reported Device Performance (for Material Properties)

The acceptance criteria and reported performance relate to the physical and chemical properties of the DenMat Multilayered Zirconia Disc, as evaluated against ISO standards for dental ceramics.

Table of Acceptance Criteria and Reported Device Performance:

3.5 MPa√m (for Single Crown Units & 3 Unit Bridges)
Minimum for Class 5: 4.0 MPa√m (overall) | 4.14 ± 0.43 MPa√m | 4.21 ± 0.48 MPa√m | ISO 6872: 2024 (ISO 18756/ASTM C1421) | Pass |
| Sintered Density | ≥ 6.0 g/cm³ | 6.11 ± 0.05 g/cm³ | 6.05 ± 0.03 g/cm³ | ISO 13356: 2015 | Pass |
| Radioactivity | Not more than 1.0 Bq g⁻¹ of Uranium238 | 800 MPa | 1085.51 ± 265.06 MPa | N/A (Tested once for material composition) | ISO 6872: 2024 | Pass |

Non-Applicable or Unknown Information (Due to the Nature of the Device)

The following information pertains to AI/ML device studies and is not applicable to this 510(k) for a dental material:

1. Sample size used for the test set and the data provenance: Not applicable. These are laboratory tests on material samples, not patient data. The quantity of material samples tested is not explicitly stated in the summary, but typical for these types of tests (e.g., multiple specimens for each property). Data provenance is "lab testing."
2. 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 adherence to certified test methods and instrumentation, not expert consensus on medical images/data.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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/imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental material, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for material properties is defined by the physical/chemical standards and measurements themselves as per ISO and ASTM guidelines (e.g., measured force for flexural strength, measured mass change for solubility).
7. The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, the DenMat Multilayered Zirconia Disc is a dental material, and its acceptance criteria and proving study focus on demonstrating that its physical and chemical properties meet established international standards (ISO, ASTM) for dental restorative materials, ensuring its safety and effectiveness for its intended use. It is not an AI software device, and therefore the assessment methodologies typically associated with AI/ML-based medical devices do not apply here.

Ask a specific question about this device

Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. All zirconia block are processed through dental laboratories or by dental professionals.

Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) used to produce dental restoration to support designing computer for dental use and to process cutting as a manufacture unit, on which CAD/CAM system is applied for processing and sintering. After application, this material cannot to be reused for fabrication.

The provided FDA 510(k) clearance letter pertains to a Non-Sterile Zirconia Block used for dental restorations. This document focuses on demonstrating the substantial equivalence of the new device (ARENA Star, Galaxy Star) to a predicate device (Non-Sterile Zirconia Block, K223253) based on its material properties and chemical composition, not on an AI or software-driven diagnostic or assistive system.

Therefore, the requested information about acceptance criteria, study design for AI performance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance does not apply to this submission. This is a material science and manufacturing equivalency clearance, not a performance study for AI.

However, I can extract the acceptance criteria related to the material properties and the type of non-clinical testing performed.

Updated Information based on the provided document:

Acceptance Criteria and Device Performance for ARENA Star, Galaxy Star (Non-Sterile Zirconia Block)

The acceptance criteria for this device are based on demonstrating mechanical and biological equivalence to a predicate device and adherence to international standards for dental ceramic materials.

1. Table of Acceptance Criteria and Reported Device Performance:

The remaining information requested is typically relevant for AI/ML-based medical devices, which operate on analyzing data (e.g., images, signals) and often involve performance metrics like sensitivity, specificity, accuracy, and comparisons to human expert performance. This 510(k) submission is for a physical medical device (zirconia block), where the "study" demonstrating criteria fulfillment is primarily non-clinical bench testing and chemical analysis to confirm material properties and biocompatibility.

Therefore, for aspects like "Sample size for the test set," "Experts used to establish ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Type of ground truth," "Training set sample size," and "Ground truth for the training set" – these points are not applicable to this specific device and the information provided in the 510(k) clearance letter. The "ground truth" here is established through standardized material testing methods and chemical analysis, not through expert interpretation of data.

Ask a specific question about this device

The Multi M Series is used in the manufacture of dental prosthesis.

Multi M Series is zirconia-based ceramic provided in various shapes such as round and it is used to manufacture cores of all ceramic crowns and is classified into ISO 6872 Type 2 Class 5. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers 278 different shades to meet the needs of different patients' tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine. Multi M Series offers various types as follows: W-type, Z-type. These different types are to accommodate the different types of the jig that is built-in CAD/CAM machine. Users can choose a type which fits the jig they have.

This document is a 510(k) clearance letter for a medical device called "Multi M Series", which is a dental material. The standard 510(k) clearance process by the FDA does not typically include the kind of clinical study details usually associated with AI/ML-based diagnostic devices (e.g., sample size for test sets, expert consensus, MRMC studies, effect size of AI assistance). This device is a material, not a diagnostic algorithm.

Therefore, many of the requested points regarding acceptance criteria and study details (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of device and submission. The "study" here refers to non-clinical performance and biocompatibility testing against international standards.

However, I can extract the relevant information where it exists:

The device in question, "Multi M Series," is a dental material (zirconia-based ceramic) used to manufacture dental prosthetics, not an AI-powered diagnostic device. Therefore, the "acceptance criteria" and "study" described are based on non-clinical performance and biocompatibility testing against established international standards for dental materials, rather than clinical efficacy studies with human subjects or AI algorithm performance benchmarks.

Acceptance Criteria and Device Performance

The acceptance criteria are derived from ISO 6872 (for ceramic materials) and ISO 10993 (for biocompatibility).

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

Types of restorations:

1. Anterior and posterior crowns
2. Veneers, inlays, onlays.

zirconia layering porcelain system layering ceramic powders and pastes are used in dental laboratories by the dental technician to create ceramic restorations.

The provided FDA 510(k) clearance letter and summary are for "zirkon; structure; LFU shades, stains and glazes," which are dental ceramic materials (porcelain powder for clinical use), not a medical device that relies on an algorithm or AI for diagnostic or treatment assistance. Therefore, the document does not contain any information regarding acceptance criteria related to device performance in the context of AI/algorithm a medical device, nor does it describe a study to prove such performance.

The "acceptance criteria" and "study" described in the input prompt are typically associated with AI/ML-based medical devices or diagnostic tools where performance metrics like sensitivity, specificity, or reader improvement are critical for demonstrating safety and effectiveness.

The information provided in the FDA document focuses on the equivalence of the dental ceramic materials to a predicate device based on:

• Intended Use: Types of dental restorations (crowns, veneers, inlays, onlays).
• Technological Characteristics: Physical state (powder/paste), material composition (silicate glass ceramics), and classification according to ISO 6872:2019.
• Bench Testing: Compliance with physical properties (flexural strength, chemical solubility, thermal expansion, glass transition temperature, radioactivity) and biocompatibility according to ISO 7405:2018 and ISO 10993:2018.

Therefore, it is impossible to extract the requested information (table of acceptance criteria with device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text, as these concepts are not applicable to the type of device described.

Ask a specific question about this device

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.

Ask a specific question about this device

Biomic Color Opaque is liquid used for coloring pre-sintered zirconia restorations. It is used for the internal surface of dental zirconia material prosthesis.

Biomic Color Opaque is a liquid primarily composed of Methylacryloyl propyl trimethoxy silane, deionized water, 1, 3-butanediol, ferric chloride, citric acid, cerium nitrate, erbium nitrate, cobaltous nitrate, manganous acetate, and aluminum nitrate.

This product is designed for use on the internal surface of dental zirconia material prostheses. It penetrates tightly with the zirconia surface, forming an extremely thin shade layer that reduces the internal surface permeability of the zirconia material prosthesis. The devices are intended to be used solely by dental technicians for the fabrication of zirconia restorations for individual dental patients.

For staining, the zirconia materials must be immersed into the staining solution or brushed with the liquid before sintering at high temperature. The staining solution consists of two components: Type I - a color component (A、B、C、D、W、L、M、R、S、X), and Type II - an OP component, 1:1 collocation is recommended. These components are mixed together for use on the zirconia material to achieve the desired shade.

The provided FDA 510(k) clearance letter and its accompanying summary for the "Biomic Color Opaque" device do not contain information about clinical studies or performance data related to AI/algorithm-driven performance, ground truth establishment, or multi-reader multi-case (MRMC) studies.

The document explicitly states under Section 7.0, "Summary of Clinical Test," that "Clinical testing was not required for this submission." This indicates that the device's clearance was based on non-clinical data (bench testing, biocompatibility, sterility, shelf-life) and a comparison to a predicate device, not on AI/algorithm performance. The device itself is a "Porcelain Powder For Clinical Use" (specifically a pre-sintered zirconia coloring liquid), not an AI-driven diagnostic or image analysis tool.

Therefore, it is impossible to provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/algorithm-driven study based solely on the provided text.

However, I can extract the acceptance criteria and performance related to the physical and chemical properties of the device, as that is the type of testing described.

Here's a summary of the acceptance criteria and performance as described for this specific device (a coloring liquid), not for an AI algorithm:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

Regarding the AI/Algorithm-Specific Questions:

Since the device is a dental coloring liquid and not an AI-driven device, the following information is not applicable or not provided in the document:

• Sample size used for the test set and the data provenance: Not applicable; no AI test set described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth for AI performance required.
• 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.): Not applicable to an AI device. The ground truth for this device's performance relates to its physical/chemical conformity to standards.
• The sample size for the training set: Not applicable; no AI training set.
• How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document details the regulatory clearance for a traditional medical device (dental coloring liquid) based on its physical, chemical, and biological properties, and its substantial equivalence to a predicate device. It does not pertain to the evaluation of an AI-powered medical device.

Ask a specific question about this device

ZircaGlow & ZircaGlow HT Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.

ZircaGlow & ZircaGlow HT Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as a crown, bridge or coping.

The provided FDA 510(k) clearance letter details a dental product (zirconia blanks) and its substantial equivalence to a predicate device, rather than a medical device that utilizes artificial intelligence or machine learning. Therefore, many of the requested criteria related to AI/ML device performance (e.g., ground truth, expert adjudication, MRMC studies, effect size of AI assistance, training set details) are not applicable or cannot be extracted from this document.

However, I can provide information based on the physical and chemical properties and the nonclinical testing performed to establish substantial equivalence.

Acceptance Criteria and Device Performance for ZircaGlow & ZircaGlow HT Zirconia

The device is a dental material (zirconia blanks) and its performance is evaluated against material properties and compliance with industry standards, comparing it to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for ZircaGlow & ZircaGlow HT Zirconia are primarily based on meeting or exceeding the requirements of established international standards (ISO 6872:2024 and ISO 13356:2015) for dental ceramic materials, and demonstrating similar performance characteristics to a predicate device.

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

The document does not explicitly state the sample sizes for the mechanical and chemical property tests. The data provenance is derived from nonclinical testing performed by United Zirconia on their ZircaGlow and ZircaGlow HT Zirconia blanks. The location of the testing is not specified, but the applicant's address is Cairo, Egypt. This testing is prospective in the sense that the manufacturer specifically conducted these tests to demonstrate compliance for regulatory submission.

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

This is not applicable as the tests are for material properties, not for diagnostic or predictive performance requiring human expert ground truth.

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

Not applicable for material properties testing. The values are determined by standardized laboratory methods.

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 dental material, not an AI-powered diagnostic device.

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

Not applicable. This is a dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device is based on objective measurements of physical and chemical properties determined through standardized laboratory testing methods (e.g., ISO 6872:2024, ISO 13356:2015). This is not equivalent to expert consensus, pathology, or outcomes data used for diagnostic devices.

8. The sample size for the training set

Not applicable. This is a dental material, not a machine learning model.

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

Not applicable. This is a dental material, not a machine learning model. The relevant "truth" for the manufacturing process would be adherence to quality system regulations (21 CFR Part 820).

Ask a specific question about this device

The Dentsply Sirona Titanium Bases system is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For AT EV 3.0 S, AT TX 3.0 S, BH 3.0 S, and SB L 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.

The system comprises three parts:

• Abutment Block material (CEREC Cercon 4D Abutment Block)
• Titanium Base (TiBase)
• CAD/CAM system

The TiBase is recommended for use with two-piece hybrid abutments and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The proposed Dentsply Sirona Titanium Bases system are connected to Dentsply Sirona or third-party dental implants to facilitate the prosthetic dental restoration of edentulous areas of the oral anatomy. The proposed TiBase components are assembled (through extraoral cement bonding) with the patient specific CEREC Cercon 4D Abutment Block (K234018), to form the complete, two-piece CAD/CAM Titanium Base system abutments. The bottom half of the abutment is the TiBase component, which interfaces with the implant system-specific geometry, while the top half of the abutment is the abutment block material that is milled to form either an abutment crown or a meso-structure (the latter is subsequently finished with a crown). The TiBase component therefore serves as the "platform" on which the customized milled abutment crown or the meso-structure is bonded to, forming the complete CAD/CAM Titanium Base system abutment. The completed CAD/CAM Titanium Base system abutment is attached to the dental implant with an abutment screw.

The TiBase system is part of a workflow that includes CAD/CAM software cleared in predicate device, K193408, CAD/CAM system with CEREC Chairside Software, and reference device, K200191, CAD/CAM System with inLab Software, and the abutment crown and meso-structure material cleared in reference device, K234018.

The TiBase components are made of the same material as the predicate device (K193408) TiBases, which is titanium alloy Ti6Al4V, complying with ASTM F136-13. While the lower part connects to the implant system, the upper part consists of a tapered, cylindrical center post which is designed to receive the abutment crown or meso-structure to complete the finished CAD/CAM abutment.

The TiBase components come in small and large sizes depending on the diameter size of the connecting implant. A notch feature on the cylindrical part of the upper portion (i.e. rotational reference and lock) ensures that there is only one position to mount either a scanbody or the abutment crown/meso-structure.

The TiBase component center post includes a through-channel through which a corresponding abutment screw is inserted to allow retention of the finished abutment to the implant. The abutment screw, made of the same Titanium material, when assembled with the proposed TiBase component, is located in the internal geometry of the titanium base and does not seat in the finalized abutment crown/meso-structure.

The minimum/maximum design specification limits are as follows:

• Maximum angulation for the Zirconia top-half material: 20˚
• Minimum wall thickness of the Zirconia top-half material: 0.5 mm
• Gingival heights of the TiBase component: 1, 2, 3 mm
• TiBase component post height (i.e., length above the gingival height): ≥ 4 mm

This document is a 510(k) clearance letter for the Dentsply Sirona Titanium Bases system, which specifies its indications for use and compares it to predicate and reference devices to demonstrate substantial equivalence. It does not describe the specific acceptance criteria and detailed study results that prove the device meets those criteria in a format applicable to AI/ML software performance studies.

The document details the technical aspects of the dental implant components and their mechanical testing for safety and performance (e.g., fatigue testing), biocompatibility, reprocessing validation, and MR compatibility. However, it does not involve the types of performance metrics, test set characteristics, or ground truth establishment typically associated with AI/ML device evaluations.

Therefore, for aspects related to AI/ML device performance (like accuracy metrics, expert review, MRMC studies, standalone performance), the answer is "Not applicable" or "Not provided" as this is a traditional medical device clearance, not an AI/ML software clearance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests that the device was subjected to and that it "met acceptance criteria" or "showed similar results" to reference devices. However, the specific quantitative acceptance criteria (e.g., "fatigue strength must be > X N") and the exact reported quantitative performance values achieved by the Dentsply Sirona Titanium Bases system are not explicitly stated in this clearance letter. The letter generally refers to compliance with standards.

For example, for fatigue testing, it states: "The TiBases systems were subjected to fatigue testing per the following requirements and showed similar results when compared to the reference devices (K213961, K241485)" and refers to ISO 14801:2016 and FDA Special Controls Guidance. It does not provide the numerical results or the specific acceptance mechanical load values. The same applies to MR testing, reprocessing, and biocompatibility.

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

• Sample Size: Not explicitly stated in terms of the number of unique devices/tests in the provided text. The fatigue testing mentions "the proposed device performs as well as the reference devices (K213961, K241485)," implying a comparison and potentially new tests for the specific new TiBases. However, specific counts are not given.
• Data Provenance: The studies are non-clinical (laboratory tests) rather than human patient data. Therefore, "country of origin" and "retrospective/prospective" are not applicable in the context of patient data. The tests were performed to demonstrate compliance with international standards (ISO, ASTM) and FDA guidance.

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

• Not Applicable (N/A). This is a mechanical/material device clearance, not an AI/ML software evaluation based on expert-labeled data. The "ground truth" for these tests refers to the objective results conforming to engineering and material science standards (e.g., a device either fractures at a certain load or it doesn't, a material is biocompatible or not).

4. Adjudication method for the test set

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This is not an AI/ML software device that involves human interpretation of medical images.

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

• Not Applicable (N/A). This is a physical device, not an algorithm. The "software system verification" refers to confirming that the CAD/CAM software correctly integrates the design parameters for the physical components, not an AI algorithm's standalone diagnostic performance.

7. The type of ground truth used

• For mechanical (fatigue) testing: Compliance with ISO 14801:2016 and FDA guidance, meaning the physical behavior of the device under specified loads.
• For MR testing: Compliance with ASTM standards, meaning objective measurements of displacement, torque, and image artifacts.
• For software verification: Conformation that design parameters are correctly implemented in CAD/CAM software.
• For reprocessing and biocompatibility: Compliance with ISO standards and FDA guidance, meaning objective evaluations of sterility and biological response.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

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

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

Ask a specific question about this device

Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

Dental Zirconia Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Co3O4). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.

Dental Zirconia Ceramic has 19 models mainly according to the flexural strength (i.e. ≥600Mpa and ≥800Mpa) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And it also offers various shapes and dimensions suitable for different milling systems.

The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.

The proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015/AMD 1:2018 Dentistry: Ceramic Materials.

I'm sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "Dental Zirconia Ceramic" device. This document does not contain the specific information you requested regarding acceptance criteria and a study proving device performance, particularly related to AI/software aspects.

The document discusses:

• Device Name: Dental Zirconia Ceramic
• Regulation Number: 21 CFR 872.6660 (Porcelain Powder For Clinical Use)
• Regulatory Class: Class II
• Product Code: EIH
• Intended Use: Dental restorations using CAD/CAM or manual milling machines.
• Non-clinical Test Conclusion: Physical and mechanical properties evaluated according to ISO 6872:2015/AMD 1:2018 and ISO 13356:2015. Biocompatibility testing performed.
• Technological Characteristics: Yttria-stabilized zirconia composition, inorganic pigments for color.
• Comparison to Predicate Device: Notes similarities in intended use, patient population, principle of operation, and mechanism of action. Highlights differences in the number of models offered (new models added).
• Conclusion: Substantial equivalence to the legally marketed predicate device based on comparison and analysis.

However, it does not provide:

1. A table of acceptance criteria and reported device performance in a measurable format for software or AI.
2. Sample size used for the test set and data provenance for a software algorithm.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study information (human readers improve with/without AI assistance).
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The device described is a ceramic material for dental restorations, not an AI or software-based medical device. Therefore, the specific types of studies and criteria you're asking about (MRMC, standalone performance, training/test sets, ground truth establishment for AI) are not present in this document.

Ask a specific question about this device

Porcelain Powder can be used to make facings and veneers of customized denture crowns. It is suitable for adults over 18 years old.

This product includes Porcelain Powder, Stain/Glaze, Stain/Glaze-A and Modeling Fluid.

Enamel/ Modifier is Enamel porcelain, its function is to make adjusted porcelain powder gently stacked in the incisal aimed at shape, and stack from incisal to the body, covering dentin porcelain:

Stain/Glaze and Stain/Glaze-A is Enamel layer, its function is to coat with a thin layer of glaze on the surface of the finishing porcelain crown to achieve the required color and gloss of natural teeth.

Modeling Fluid: A dental ceramic powder is mixed in order to shape or model it into its required form prior to firing

The provided text is an FDA 510(k) summary for a dental product, "Porcelain Powder." It outlines the product's classification, intended use, and a comparison to a predicate device to establish substantial equivalence.

Crucially, this document is for a dental material (Porcelain Powder), not a medical device software (MDSW) or an AI/ML-driven device. Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, expert adjudication, MRMC studies, and standalone performance for AI/ML devices is not present in this regulatory submission.

The document states: "Clinical testing was not required for this submission." This indicates that no human performance or comparative effectiveness studies were conducted for this traditional material device. The "Non-clinical Test Conclusion" section primarily refers to bench testing for physical and mechanical properties, and biocompatibility testing.

To answer your prompt with the provided input, I must state that the requested information (acceptance criteria, study details for AI/ML device performance) is not applicable to the Porcelain Powder device and is not contained within this 510(k) summary.

Therefore, I cannot populate the table or provide the requested details about acceptance criteria, study design, ground truth, or expert involvement as this information pertains to a different type of medical device (AI/ML or diagnostic software) than the "Porcelain Powder" described in the provided text.

Ask a specific question about this device