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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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