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Cercon® yo ML is indicated in the anterior and posterior segments for:

• Crowns
• Multi-unit bridges (with a maximum of two pontics between abutment crowns)
• Inlays, onlays and veneers

The proposed Cercon® yo ML is a partially sintered ceramic blank composed of yttrium oxide-(yttria-) stabilized zirconium oxide (zirconia) (Y-TZP). Cercon® yo ML is a multilayer disk built out of different shade layers and yttrium oxide contents which create a natural gradient of the restoration after sintering. The proposed device is supplied to dental professionals as a blank and then processed by machining and subsequent sintering to fabricate dental ceramic restorations.

The provided text describes acceptance criteria and the study conducted for the Cercon® yo ML device, specifically focusing on non-clinical performance data.

Here's a breakdown of the requested information:

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

2. Sample size 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 for the bench tests. It refers to general standards (ISO 6872, ISO 9693, ISO 10993 series) which typically define the number of samples required for each test. The data provenance is not mentioned, but these are non-clinical engineering and biological tests, not patient-specific data.

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 section is not applicable. The studies described are non-clinical bench tests and biocompatibility assessments, which rely on established scientific and engineering standards and laboratory measurements, not expert consensus for ground truth.

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

This section is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts. The described studies are non-clinical bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study or AI assistance in the provided text. The device, Cercon® yo ML, is a partially sintered ceramic blank for dental restorations, not an AI-powered diagnostic or assistive device.

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

This section is not applicable. The device is a material for dental restorations, not a software algorithm.

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

For the non-clinical performance data:

• Material properties (Flexural Strength, CTE, Solubility, Radioactivity, Shrinkage factor, Uniformity, Freedom from extraneous materials): The ground truth is based on the specified physical, chemical, and mechanical properties as defined by the ISO 6872:2015 Amd 1. 2018 standard. The "ground truth" is the established limit or range defined by the standard.
• Compatibility (De-bonding / crack-initiation, Thermal shock resistance): The ground truth is based on the specified performance criteria defined by the ISO 9693:2019 standard.
• Biocompatibility: The ground truth is established by the requirements of the ISO 10993 series of standards and USP <151>, which define acceptable biological responses and toxicity levels.

8. The sample size for the training set

This section is not applicable as the studies described are non-clinical bench tests and biocompatibility assessments, not machine learning model training.

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

This section is not applicable as there is no training set mentioned or implied for this type of device and testing.

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Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.

The subject device, Cercon® is a partially sintered ceramic blank composed of yttria stabilized zirconium oxide, (yttria stabilized tetragonal zirconia particle, Y-TZP). The subject device. Cercon® is supplied to dental professionals as a blank and then processed by machining and subsequent sintering to fabricate all ceramic restorations. Cercon® blanks are zirconia based millable blanks (yttria-) stabilized zirconium oxide (zirconia) (Y-TZP)) that are used for all ceramic restorations for anterior and posterior locations. Specifically, Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.

The subject device, Cercon® is available in various shades (colors) for esthetics. Specifically, the subject Cercon® material is offered in the following shades: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4 and white.

The sintered restorations which are fabricated using the subject Cercon® material may be veneered with compatible veneering porcelains.

The provided text describes the 510(k) premarket notification for the Dentsply Sirona Cercon®, which is a ceramic blank for dental restorations. The document focuses on demonstrating substantial equivalence to predicate devices based on physical properties and biocompatibility, as clinical performance data was not submitted.

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

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

2. Sample size 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 for the physical property tests or the finished restoration evaluations. It mentions that testing was conducted "in accordance with ISO 6872:2015 (Dentistry - Ceramic materials)" and ISO 10993-5 for biocompatibility. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it can be inferred that these are bench tests conducted in a laboratory setting for regulatory submission.

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 provided. The "ground truth" for the physical properties is defined by the ISO standards themselves. For the "predetermined acceptance criteria" for finished restoration quality, the number and qualifications of experts involved in setting or evaluating against these criteria are not mentioned.

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

The document does not describe any adjudication method. The testing appears to be based on physical measurements and evaluations against established standards, not on subjective interpretations requiring 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 is not applicable. The device (Cercon®) is a zirconia-based ceramic material for dental restorations, not an AI-assisted diagnostic or treatment planning tool. No MRMC study was conducted or is relevant to this device.

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. The performance described is inherent to the material properties and the final restoration's physical characteristics, not an algorithmic output.

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

The ground truth for the physical properties is established by international standards (ISO 6872:2015 and ISO 10993-5). For the finished restoration evaluations, the ground truth was based on "predetermined acceptance criteria," which would likely have been derived from dental engineering and clinical best practices for material performance. No pathology or outcomes data is mentioned here for establishing ground truth.

8. The sample size for the training set

This is not applicable. Cercon® is a material, not a machine learning model, so there is no concept of a "training set" in this context.

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

This is not applicable, as there is no training set for this device.

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Cercon® ht is indicated in the anterior and posterior segments for:

• crowns
• telescopic primary crowns
• multi-unit bridges (with no more than two pontics between abutment crowns)
  Cercon® ht can be used as a substructure (framework) which is then veneered with a dental veneering ceramic or can be used for full-contour application (without veneering) as well. In the case of telescopic primary crowns the substructure is not veneered.

Cercon ht is a ceramic composed of partially sintered yttria stabilized zirconia powder (Y-TZP). It is supplied to the dental laboratory as a blank and then processed in the dental-laboratory by machining and subsequent sintering to full density. It can be veneered with a dental veneering ceramic or can be used as anatomically shaped full-contour crown or bridge without veneering. It is designed for anterior and posterior locations as a substructure (framework) for single-tooth or bridge type restorations. It can also be used for the preparation of telescopic primary crowns.

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 used for each non-clinical test (flexural strength, solubility, wear tests, fit tests, telescopic primary crown tests). The data provenance is not specified regarding country of origin; however, the tests were "Non-Clinical Performance Data" and "bench tests and professional evaluations" performed to demonstrate substantial equivalence to a predicate device. This suggests lab-based, retrospective testing rather than prospective clinical trials.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. It mentions "professional evaluations" in the context of proving substantial equivalence but does not detail the methodology for these evaluations.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. Given the non-clinical nature of the tests, adjudication for human-based assessment as seen in clinical trials would not typically apply. The evaluation seems to rely on direct measurement and comparison to established benchmarks or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies solely on non-clinical performance data (mechanical and chemical property testing, wear tests, fit tests). The document explicitly states: "Clinical Performance Data. Not applicable."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the device described. Cercon ht is a physical dental material (zirconia ceramic) and not a software algorithm or AI device that would have "standalone" performance in the context of human-in-the-loop assessments.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be based on:

• Established physical and chemical properties: Standardized measurements for flexural strength and solubility.
• Comparative data against predicate device: Evaluating if Cercon ht performs "the same as" the predicate Cercon Base for mechanical and chemical properties.
• Benchmarks against conventional materials: Comparing wear to "conventional veneering porcelain" and fit to "conventional metal cast frameworks."
• Qualitative assessments of fit and surface quality: "good fitting accuracy and a good surface quality."

8. The Sample Size for the Training Set

This question is not applicable. Cercon ht is a physical dental material, not an AI/ML model that requires a "training set."

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

This question is not applicable as there is no training set for a physical dental material.

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Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include tooth anterior and posterior locations.

The CERCON® CERAM EXPRESS Ceramic System consists of a dental ceramic veneering material developed for veneering zirconium oxide substructures for fixed prosthodontics devices that include both anterior and posterior crowns and bridges. The modified device is a glass/glass-ceramic mixture used to veneer zirconia substrates in a medium-pressure. lost-wax injection molding (pressing) process. The modified device consists of a translucent material and an opaque material.

This 510(k) K041707 submission focuses on a dental ceramic veneering material (CERCON® CERAM EXPRESS Ceramic System) and demonstrates substantial equivalence to a predicate device, Cercon® Ceram S Porcelains (K022796).

The provided text does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology (sample size, expert qualifications, adjudication, etc.) of such a study.

Instead, the submission primarily focuses on:

• Device Description and Intended Use: CERCON® CERAM EXPRESS Ceramic System is a glass/glass-ceramic mixture for veneering zirconia substructures in fixed prosthodontics.
• Technological Characteristics: It's a modification of an existing device (Cercon® Ceram S Porcelains, K022796) with changes to formulation, material form, and processing.
• Basis for Substantial Equivalence: The manufacturer asserts substantial equivalence based on the prior use of components in legally marketed devices, similarity in formulations, and data regarding modifications. This implies that the modifications did not introduce new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document.

It's important to understand that for materials like this, "performance" is often demonstrated through mechanical and biocompatibility testing (e.g., flexural strength, bond strength, cytotoxicity) rather than clinical studies with human readers or AI algorithms as would be relevant for diagnostic imaging devices. Such tests would typically compare the modified device's properties to the predicate device or established standards. However, the details of these tests are not present in the provided summary.

Here's what can be inferred or stated about what is NOT present:

1. Table of Acceptance Criteria and Reported Device Performance: Not available in this document.
2. Sample Size and Data Provenance (Test Set): Not applicable or not reported for the type of comparison made. There is no "test set" in the context of human readers or AI performance.
3. Number of Experts and Qualifications (Ground Truth): Not applicable.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not conducted or reported. This device is a material, not a diagnostic tool requiring human reader interpretation or AI assistance in that sense.
6. Standalone (Algorithm Only) Performance: Not applicable. There is no algorithm.
7. Type of Ground Truth Used: Not applicable in the context of expert consensus, pathology, or outcomes data for a diagnostic algorithm.
8. Sample Size for Training Set: Not applicable. There's no AI model being trained.
9. How Ground Truth for Training Set was Established: Not applicable.

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Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.

CERCON® CERAM S PORCELAIN is a dental ceramic veneering material developed for veneering Cercon zirconia or an equivalent zirconium oxide substructure for fixed prosthodontics devices that include both anterior and posterior crowns/bridges. The CERCON® CERAM S PORCELAIN System consists of Dentin/Transparent/Incisal, Liner/Opaque, Shoulder, and Correction/Glaze/Stain Porcelains. The final restoration matches more shades than the predicate device.

This document is a 510(k) summary for a dental ceramic veneering material named CERCON® CERAM S PORCELAIN. It does not contain information about a study with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the context of device performance metrics typically associated with AI/ML devices or diagnostic tools.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Cercon® Ceram K011333) based on:

• Device Description: It describes the use of the new porcelain for veneering zirconia substructures in fixed prosthodontic devices.
• Intended Use: It specifies the use on zirconia for single tooth or bridge type restorations in anterior and posterior locations.
• Technological Characteristics: It highlights that CERCON® CERAM S PORCELAIN is a modification of the predicate device with minor formulation changes.
• Biocompatibility: It states that the device was evaluated and passed biocompatibility testing for cytotoxicity.
• Components: It mentions that all components have been used in legally marketed devices.

The conclusion is that the prior use of components, similarity in formulation, and biocompatibility data support the safety and effectiveness of the new device.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document is a regulatory submission for a material, not a diagnostic or AI-powered device that would typically involve such performance studies.

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Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density. It is designed for use as a substructure (framework) for single tooth or bridge type restorations. Applications include both anterior and posterior locations.

Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density.

I am sorry, but based on the provided text, I cannot extract any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a dental ceramic device named "Cercon Base." It primarily discusses the regulatory approval process, classification, and general compliance requirements for marketing the device. There is no mention of specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

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Ask a specific question about this device