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The Perfit FS Dental Zirconia Fully Sintered Block is used for dental restorations using different CAD / CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

The Perfit FS Dental Zirconia Fully Sintered Block consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre shaded, fully sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.

The Perfit FS Dental Zirconia Fully Sintered Block are zirconia oxide block made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the Zr02 so that its final properties can be achieved.

They are available in different models that differ in various specification and color. There are white zirconia products(White) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, White) color products , Shade multi-layer(ML A1/A2/A3, A1M, A2M, A3M, A3.5M, A4M, B1M, B2M, B3M, B4M, C1M, C2M, C3M, C4M, D2M, D3M, D4M) color products.

The white zirconia is composed of Zr02+Y203+Nb205 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 and other oxide. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs that matches natural color of patient's teeth.

The composition of the Dental Zirconia Block including the white zirconia and the color zirconia conforms to ISO 13356:2015. Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.

Here's an analysis of the provided FDA 510(k) summary regarding the Perfit FS Dental Zirconia Fully Sintered Block, focusing on acceptance criteria and the study proving it meets those criteria:

Device: Perfit FS Dental Zirconia Fully Sintered Block
K Number: K222686
Predicate Device: K203590, "Perfit FS Dental Zirconia Blank, Perfit ZR UT Dental Zirconia Blank" manufactured by Vatech acucera, Inc.

This submission is for a dental material (zirconia blocks) used for creating dental restorations, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study designs relevant to AI (like MRMC studies, human-in-the-loop performance, expert consensus for ground truth, training set information) are not applicable to this type of medical device.

The acceptance criteria here pertain to the physical, chemical, and biological properties of the material to ensure it is safe and performs as intended.

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 the sample sizes for the "test set" in the traditional sense of a clinical or image-based study. Instead, it refers to bench testing of the material itself according to various ISO standards. These standards typically specify the number of samples required for each particular test (e.g., flexural strength, solubility, biocompatibility assays). The provenance of the data is the manufacturer, Vatech acucera, Inc., as they performed the comparative study and conducted the bench tests. It is retrospective in the sense that the results are presented after the tests were completed. There is no information regarding the country of origin of "data" in the context of patient data, as this is a material science evaluation.

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

This question is not applicable for this type of device. The "ground truth" for material properties is established by adherence to recognized international standards (ISO standards) and by direct measurement of physical, chemical, and biological characteristics, not through expert human interpretation of images or clinical outcomes in the same way an AI diagnostic device would be evaluated. The "experts" involved would be material scientists, chemists, and toxicologists who conducted and interpreted these standardized tests.

4. Adjudication Method for the Test Set

This question is not applicable for this type of device. Adjudication methods like "2+1" or "3+1" are used to establish consensus or resolve discrepancies among human readers or experts when determining ground truth for clinical or image-based assessments. For material testing, the "ground truth" is derived directly from standardized measurement procedures and acceptance limits defined by the ISO standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools (often AI-assisted) and how they impact human reader performance. The Perfit FS Dental Zirconia Fully Sintered Block is a dental restoration material, not a diagnostic device.

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

Not applicable. This device is a material, not an algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• International Standards: Adherence to the specifications and performance criteria defined in recognized ISO standards (e.g., ISO 6872:2015, ISO 13356:2015, ISO 10993 series for biocompatibility).
• Direct Measurement & Material Analysis: Physical, chemical, and biological properties (e.g., flexural strength, solubility, elemental composition, cytotoxicity) are directly measured and compared against the defined limits within these standards and against the predicate device.
• Predicate Device Equivalence: The subject device's properties (material, performance, indications for use) are directly compared to those of the legally marketed predicate device (K203590) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a material, not a machine learning model. Therefore, there is no "training set."

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

Not applicable. As there is no training set for a material, this question does not apply.

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The Perfit FS Dental Zirconia Fully Sintered Block is used for dental restorations using different CAD / CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

The Perfit FS Dental Zirconia Fully Sintered Block consists of zirconium oxide which compresses ceramic for milling, grinding. It is a preshaded, fully sintered product and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc. The Perfit FS Dental Zirconia Fully Sintered Block are zirconia oxide block made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. They are available in different models that differ in various specification and color. There are white zirconia products(White) and colored zirconia products, and colored zirconia is also divided into Monolaver(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products , Shade multi-laver(ML A1/A2/A3, A1M, A2M, A3.5M, A4M)color products. The white zirconia is composed of Zr02+Y203+Nb205 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 and other oxide. The composition of the Dental Zirconia Block including the white zirconia and the color zirconia conforms to ISO 13356:2015. Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.

The document provided is a 510(k) premarket notification for a dental zirconia block. It describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain information about software or an AI-powered device, nor does it detail a study proving device performance against acceptance criteria in the way envisioned by the prompt's request for AI/diagnostic performance metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details for an AI-powered device. The document is about a material used in dentistry, not an AI software or diagnostic device that would involve ground truth, expert readers, or AUC.

Here's an explanation of why the requested information cannot be extracted from this document:

• Device Type: The device is "Perfit FS Dental Zirconia Fully Sintered Block," which is a material used for dental restorations. It is not an AI/ML-powered diagnostic tool.
• Performance Metrics: The performance criteria mentioned ("Flexural strength," "Solubility," "Radioactive uranium-238 active concentration") are physical and chemical properties of the material, not diagnostic or AI performance metrics like sensitivity, specificity, or AUC.
• Study Type: The studies conducted are "Non-clinical Test Conclusion" based on ISO standards (e.g., ISO 6872:2015 for ceramic materials, ISO 10993 for biocompatibility) to assess the material's properties and safety. These are not clinical studies for diagnostic accuracy or human-in-the-loop performance.
• Ground Truth/Experts/Adjudication: These concepts are relevant for diagnostic devices where a truth reference (e.g., pathology, clinical outcome) is established by experts to evaluate the device's accuracy. They are not applicable to the evaluation of a dental material's physical properties.
• Training/Test Set: These relate to a machine learning model's development and evaluation, which is not described in this document.

In summary, the provided document is a regulatory submission for a dental material, not an AI/ML-powered diagnostic device. Therefore, the specific questions about acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, and adjudication methods are not addressed in this text.

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Perfit ZR ST Dental Zirconia blank and Perfit ZR UT Dental Zirconia blank are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

The Perfit ZR ST Dental Zirconia blank and Perfit ZR UT Dental Zirconia blank consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre-sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.

The Perfit ZR ST Dental Zirconia blank and Perfit ZR UT Dental Zirconia blank are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. 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.

They are available in different models that differ in various specification and color. There are white zirconia products(W) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products , Shade multi-layer(A1 SM, A2 SM, A3 SM, A3.5 SM, A4 SM, B1 SM, B2 SM, B3 SM, B4 SM, C1 SM, C2 SM, C3 SM, C4 SM, D2 SM, D3 SM, D4 SM) color products and Trans&Shade multi-layer(A1 TM, A2 TM, A3 TM, A3 TM, A4 TM, B1 TM, B2 TM, B3 TM, B4 TM, C1 TM, C2 TM, C3 TM, C4 TM, D2 TM, D3 TM, D4 TM) color products.

The white zirconia is composed of ZrO2+HfO2+Y2O3 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 +Pr203 +Er203. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth.

The composition of the Dental Zirconia Blocks including the white zirconia and the color zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the device is Perfit ZR ST Dental Zirconia blank and Perfit ZR UT Dental Zirconia blank, which are dental materials, not an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance, expert adjudication, MRMC studies, and ground truth for algorithms are not applicable to this submission.

The acceptance criteria and supporting studies for this device primarily revolve around material properties and biocompatibility as defined by recognized international standards for dental ceramic materials and medical device biological evaluation.

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

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

• Test Set Sample Size: Not explicitly stated for each test (e.g., how many specimens were tested for flexural strength, or how many animals for biocompatibility). The summary indicates "A series of tests were conducted on the subject device for the Biocompatibility" and "Bench testing was performed per ISO 6872:2015 and ISO 13356:2015". These standards specify the number of samples required for each particular test.
• Data Provenance: The tests are "bench tests" and "biocompatibility tests." These are laboratory tests conducted on the manufactured material, not clinical data from patients. The location where these specific tests were conducted is not mentioned, but the manufacturer is based in Korea, South. The nature of these tests is usually prospective and controlled, following the protocols outlined in the respective ISO standards.

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 and biocompatibility assessment, not a diagnostic or AI performance study that requires expert readers for ground truth establishment. The "ground truth" here is determined by objective measurements against established international standards.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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-assisted diagnostic device. No human reader studies were conducted as part of this submission. "Clinical testing was not required for this submission."

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

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used

• For Physical and Mechanical Properties: The ground truth is defined by the objective performance requirements (e.g., minimum flexural strength, maximum solubility) specified in the relevant ISO standards (ISO 6872:2015 and ISO 13356:2015). Measurements are taken using calibrated laboratory equipment.
• For Biocompatibility: The ground truth is based on the biological responses observed in in vitro (e.g., cytotoxicity) and in vivo (e.g., sensitization, systemic toxicity) tests, as prescribed by the ISO 10993 series of standards. The "truth" is whether the material elicits a biologically acceptable response according to the standard's criteria.

8. The sample size for the training set

• Not Applicable. This device, being a dental material, does not involve machine learning or an AI algorithm, and therefore doesn't have a "training set" in the context of AI.

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

• Not Applicable. See point 8.

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

The Perfit ZR HT Dental Zirconia blank consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre-sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.

The Perfit ZR HT Dental Zirconia blank are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. 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.

They are available in different models that differ in various specification and color. There are white zirconia products(W) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products and multi-layer(A1 SM, A2 SM, A3.5 SM, A4 SM, B1 SM, B2 SM, B3 SM, B4 SM, C1 SM, C2 SM, C3 SM, C4 SM, D2 SM, D3 SM, D4 SM) color products.

The white zirconia is composed of Zr02+HfO2+Y2O3 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 +Pr203 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth.

The composition of the Dental Zirconia Blocks including the white zirconia and the color zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.

This document is a 510(k) Premarket Notification from the FDA for a dental product, "Perfit ZR HT Dental Zirconia blank." The document primarily focuses on establishing substantial equivalence to a predicate device based on non-clinical performance data and does not describe a study involving device performance for diagnostic accuracy or human-in-the-loop AI assistance.

Therefore, many of the requested details, such as acceptance criteria for diagnostic performance, sample sizes for test/training sets with data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set ground truth establishment, are not applicable to the information provided in this document.

The document describes material and performance requirements for the dental zirconia blank itself, rather than a diagnostic device that performs a "study" in the typical sense of evaluating an algorithm's accuracy.

Here's a breakdown of what can be extracted from the provided text, and where information is not applicable:

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

The acceptance criteria here are based on meeting established international standards for dental ceramic materials and biocompatibility. The reported device performance is that it met these standards.

2. Sample sized 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 as it pertains to non-clinical bench testing of material properties, not clinical diagnostic performance. The document only mentions "Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015 and ISO 13356: 2015." The tests would involve specific numbers of material samples, but these are not disclosed here.

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 information is not applicable as the evaluation is based on meeting material and biocompatibility standards through bench testing, not on human interpretation or diagnostic accuracy where expert ground truth would be established.

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

This information is not applicable for the same reasons as point 3.

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 document is for a dental material (zirconia blank), not an AI-assisted diagnostic device.

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

This information is not applicable. This is a dental material, not a standalone algorithm.

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

The "ground truth" for this device's performance is adherence to established international standards for material properties and biocompatibility as determined by standardized laboratory tests. For example, "The composition of the Dental Zirconia Blocks... conforms to ISO 13356:2015" and "Physical and mechanical properties... were evaluated according to ISO 6872:2015."

8. The sample size for the training set

This information is not applicable. This is a dental material subject to non-clinical bench testing, not an AI model requiring a training set.

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

This information is not applicable for the same reasons as point 8.

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