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CEREC Tessera Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

• CEREC Tessera Abutment Block
• TiBase
• CAD/CAM system.
  The CEREC Tessera ceramic structure 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.

The proposed CEREC Tessera Abutment Blocks are intended for fabrication of single cement-retained restorations. The CEREC Tessera Abutment System is comprised of the proposed CEREC Tessera Abutment Block, applicable TiBase, and CAD/CAM systems in both chairside (CEREC chairside software) and labside (inLab labside software) use. The CEREC Tessera ceramic structures are fabricated by milling the proposed CEREC Tessera Abutment Blocks. The CEREC Tessera Abutment Blocks are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure used to create 2-piece hybrid abutments and hybrid abutment crowns cemented to a TiBase used with dental implant systems. The patient-specific ceramic structure is then cemented to a TiBase to create the two-piece abutment which constitutes the final finished medical device.

The provided text describes a 510(k) premarket notification for the "CEREC Tessera Abutment Block, CEREC Tessera Abutment System." This is a dental device, not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML studies (such as sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to this document.

However, I can extract information regarding acceptance criteria and performance data for the dental device from the provided text.

Here's the relevant information:

1. Table of Acceptance Criteria and 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)

• Sample Size: Not explicitly stated in terms of number of test samples for each specific test, but the tests were performed "on the proposed CEREC Tessera Abutment System" and "on the proposed CEREC Tessera Abutment Block."
• Data Provenance: The studies are described as "Non-clinical bench testing" and "Biocompatibility evaluation assessment." The text does not specify the country of origin of the raw data, nor whether it's retrospective or prospective, as these terms are more typically applied to clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a medical device clearance based on non-clinical bench testing, not an AI/ML diagnostic device requiring expert interpretation for ground truth.

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

• Not applicable. This is a medical device clearance based on non-clinical bench testing.

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 medical device clearance based on non-clinical bench testing, not an AI/ML diagnostic device involving human readers.

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

• Not applicable. This is a medical device clearance based on non-clinical bench testing, not an AI/ML algorithm.

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

• For the non-clinical tests (mechanical strength, flexural strength, material properties, biocompatibility, cleaning/sterilization processes), the "ground truth" is defined by adherence to established international standards (ISO, ANSI/AAMI), FDA guidance documents, and internal engineering requirements. This is essentially a bench test standard compliance type of ground truth.

8. The sample size for the training set

• Not applicable. This is a medical device clearance based on non-clinical bench testing, not an AI/ML device requiring a training set.

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

• Not applicable. This is a medical device clearance based on non-clinical bench testing, not an AI/ML device requiring a training set.

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Dentsply Sirona Universal Spray Glazes are aerosol glazing porcelains used to glaze high-strength glass ceramic and zirconia dental restorations. The glaze sprays are applied to restorations and fired.

The proposed devices, Dentsply Sirona Universal Spray Glazes are sprayable glazing porcelains, intended for glazing the surface of dental restorations. The glazes are supplied to dental professionals in an aerosol can. Different variations of glazes are available to meet the aesthetic preferences of dental professionals and patients. Variations with or without fluorescing agent come in a ready-to-use spray can. Variations are distinguished by the names, "Fluo" or "No Fluo" to designate the presence of fluorescing agents in the product.

No mixing is required by dental professionals as different glaze options (with or without fluorescing agent) are supplied to dental professionals in a ready-to-use form. The addition of the fluorescing agent contributes to a more aesthetic natural looking restoration.

The proposed devices, Dentsply Sirona Universal Spray Glazes, are applied on the surface of the dental restoration (example: fixed dental prostheses such as crown or bridge) in a thinuniform layer. After initial application, the restoration is then fired in a furnace for further processing. An additional layer of the proposed Dentsply Sirona Universal Spray Glazes can be applied after first firing, if necessary. If additional layer is applied, the dental restoration is placed again in the dental furnace for final firing.

This document is a 510(k) Premarket Notification for Dentsply Sirona Universal Spray Glazes. It focuses on demonstrating substantial equivalence to a predicate device, CEREC SpeedGlaze (K160099), for dental glazing purposes. The provided information does not describe a study that uses an AI/ML algorithm or requires a detailed ground truth establishment process involving multiple experts.

The acceptance criteria provided and the study conducted are for a physical material (dental glaze), not an AI/ML device. Therefore, many of the requested bullet points for an AI/ML study (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract the relevant information from the document regarding the acceptance criteria and the performance study undertaken for this dental glaze product.

Here's a breakdown of the requested information based on the provided document, highlighting what is applicable and what is not:

Device Name: Dentsply Sirona Universal Spray Glazes

Device Type: Aerosol glazing porcelains for dental restorations (a physical material, not an AI/ML device).

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

The acceptance criteria are derived from the ISO 6872:2015 - Dentistry - Ceramic materials standard for Type I Class 1 materials. The reported device performance is stated as meeting these criteria.

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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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