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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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Zenolux are milling blanks, which are intended to be used by professional dental technicians for the CAD/ CAM -fabrication of all-ceramic crowns and 3-unit bridges, in the anterior as well as posterior tooth region. These parts can be used as framework for veneering with suitable dental porcelain and/ or as full-contour monolithic restorations.

Zenolux is a discoidal shaped, pre- sintered dental ceramic material that is composed of pure aluminium oxide (> 99,5%). It is a ready- to-use milling blank, which has to be processed in a milling machine with the CAD/CAM technology to achieve the desired shape. Thereafter, the milled unit has to be sintered at high temperatures (about 1350°C) to attain its nominal density and final chemical, physical and biological properties, which ensure its excellent effectiveness and safety, as well as its pleasant aesthetical translucency. Sintered Zenolux material is biocompatible, insoluble in water and have high flexural strength. To achieve a natural and individual tooth color, Zenolux restorations can be veneered with suitable dental porcelains or simply stained and glazed, for example with Allux (K050302), Zenolux meets all applicable requirements of the standard ISO 6872: 2008 "Dentistry - Ceramic materials", and exceeds the thresholds for a Type II, class 5 dental ceramic by far. Zenolux encompasses diverse models, which have a diameter of about 60 mm and thicknesses from 10 mm up to 25 mm.

The provided text describes a dental ceramic material called Zenolux and its substantial equivalence to predicate devices, primarily based on bench testing against the ISO 6872:2008 standard. It does not contain information about an AI-powered medical device, clinical studies with human readers, or the establishment of ground truth by medical experts. Therefore, many of the requested categories cannot be populated from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the ISO 6872:2008 "Dentistry - Ceramic materials" standard. The specific acceptance criteria within this standard are not fully detailed, but the text states the device "exceeds the thresholds for a Type II, class 5 dental ceramic by far."

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

• Sample size: Not specified. The text mentions "Bench testing of the characteristics," but does not detail the number of samples tested for each characteristic.
• Data provenance: Not explicitly stated but implied to be laboratory bench testing conducted by the manufacturer, Wieland Dental + Technik GmbH & Co. KG (Germany). This is retrospective, as the tests were performed to support a 510(k) submission.

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

Not applicable. The ground truth for this device is based on objective measurements against an international standard (ISO 6872:2008) and comparisons with predicate devices, not expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. This was bench testing against a standard, not a study requiring adjudication of expert opinions.

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

No. This document describes a dental ceramic material, not an AI-powered medical device. Therefore, no MRMC study or AI assistance evaluation was performed.

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.

7. The type of ground truth used

The ground truth is derived from:

• Measurements against the ISO 6872:2008 "Dentistry - Ceramic materials" standard.
• Direct comparison of technological characteristics (e.g., mechanical strength, wear resistance, fit) with legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; thus, 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 an AI/machine learning model, this question is not relevant.

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