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Zenostar MT (medium translucency) are machinable zirconium oxide discs for the production of all-ceramic crowns, partial crowns and bridges in the anterior and posterior region.

Zenostar® MT Color Liquids are ready-made, water-based solutions for shading full contour restorations made from Zenostar MT. They are applied prior to sintering using the brush technique.

Zenostar MT are zirconia discs with 98.5mm width and 2 thicknesses, 14 mm and 18 mm. for use in the fabrication of dental prosthesis through the CAD/CAM milling technology. In addition, coloring liquids for shading full-contour restorations made from Zenostar MT.

The provided text describes the regulatory clearance (K152118) for the Zenostar MT dental material, a zirconium oxide disc used for dental restorations, and its associated coloring liquids. The submission focuses on demonstrating substantial equivalence to predicate devices (IPS e.max CAD/IPS e.max ZirCAD and Zenotec Zr Bridge, Zenostar Zr Translucent, Zenotec Color Zr, Zenostar Color Zr).

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample size used for the mechanical and biocompatibility testing. The data provenance is implied to be from the manufacturer's internal testing (Wieland Dental + Technik GMBH & Co. KG), likely taking place in Germany. It is a prospective study as it's part of the device's clearance process.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish a "ground truth" in the typical sense of diagnostic imaging studies. The evaluation is based on objective, standardized physical and chemical tests (e.g., flexural strength, chemical solubility, biocompatibility).

4. Adjudication Method for Test Set

Not applicable, as this is not a study requiring adjudication of expert interpretations but rather laboratory testing against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a material science study, not an AI-assisted diagnostic imaging or human-in-the-loop performance study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. There is no AI algorithm being evaluated in this submission.

7. Type of Ground Truth Used

The ground truth or benchmark used for evaluating the device's physical properties (like flexural strength) is the international standard ISO 6872:2008 for Dentistry: Ceramic Materials. For biocompatibility, the ground truth is established by adherence to standards like EN ISO 10993-1, EN ISO 7405, and EN ISO 14971.

8. Sample Size for Training Set

Not applicable. There is no AI algorithm with a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no AI algorithm with a training set.

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IvoBase CAD for Zenotec, IvoBase CAD Bond and Modelling Liquid is a system used. For the fabrication of removable dentures,e.g .: - . partial and complete denture prosthetics - . hybrid denture prosthetics - . combined denture prosthetics - . mouthguards - implant-supported denture prosthetics .

use industrially polymerized disc made primarily from PMMA. The denture base disc is milled using the CAD/CAM technique to form the base of a partial, full denture or mouthguard. Commercially available preformed denture teeth are then bonded to the denture base using lvoBase CAD Bond and IvoBase CAD Modelling Liquid.

The provided document is a 510(k) Summary for a dental device, IvoBase CAD for Zenotec, IvoBase CAD Bond, and Modelling Liquid. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of acceptance criteria and device performance in the context of an AI/ML device.

Therefore, many of the requested items, such as specific acceptance criteria for AI algorithms, sample sizes for test sets in a machine learning context, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or cannot be extracted from this type of document.

However, I can provide the available information relevant to the device's testing and comparison to predicates, framed as closely as possible to your request.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards and predicate device comparisons rather than explicitly listed with numerical targets. The "reported device performance" is a statement of substantial equivalence to the predicate based on these tests.

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify sample sizes for mechanical or biocompatibility tests, nor does it refer to "test sets" in the context of data used for AI/ML validation. The data provenance is not mentioned beyond the fact that testing was conducted for the device.

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

Not applicable for this type of device and testing. This is a medical device clearance submission for a dental material, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable for this type of device and 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 device is a dental material, not an AI-assisted diagnostic tool.

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

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth or reference standard for testing was established through:

• Compliance with international standards (EN ISO 20795-1:2013, EN ISO 22112:2005, ISO 10993, ISO 7405).
• Comparison to legally marketed predicate devices' known properties and performance.
• Laboratory testing results (e.g., verification of cohesive fracture, lack of cytotoxicity).

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning and therefore has no "training set."

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

Not applicable.

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Zenostar MO and Zenostar T consist of machinable zirconia discs for the preparation of full ceramic crowns, onlays and bridges (anterior and molar).

Zenostar VisualiZr is for the temporary dyeing of Zenostar Color Zr solutions according to the Instructions for Use.

Zenostar MO (Medium Opacity) are milling discs intended for the fabrication of crown frameworks and multi-unit bridge frameworks for use as dental restorations.

Zenostar T (Translucent) are milling blanks intended for making single-tooth and multiunit restorations for use as dental restorations. Depending on the indication, frameworks or monolithic (full contour) restorations can also be made

Zenostar VisualiZr is for the temporary dyeing of Zenostar Color Zr solutions according to the Instructions for Use.

Zenostar MO and Zenostar T are pre-sintered Zirconia discs with 98.5mm width and various thickness for use in the fabrication of dental prosthesis through the CAD/CAM milling technology. After milling, they are to be sintered at a high temperature to its full density. in order to achieve its expected physical properties. In addition, visualizer coloring liguid concentrates for dyeing Zenostar Color Zr (K11270) Solutions.

The acceptance criteria document provided describes the pre-market notification (510(k)) for dental materials, specifically Zenostar MO, Zenostar T, and Zenostar VisualiZr. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a medical device that usually involves clinical performance metrics like sensitivity, specificity, accuracy, or human interpretability.

Therefore, the following information is extracted based on the nature of this 510(k) submission, which emphasizes material properties and comparison to predicates.

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

The acceptance criteria for this type of device are primarily compliance with ISO standards for dental ceramic materials and demonstrating equivalence in performance characteristics to the predicate device. The performance is reported in relation to these standards and the predicate.

Note: For "Zenostar VisualiZr", its performance is described as an accessory that "bears no effects on the device or its comparison to the predicate" and that "the liquid burns out almost completely during sintering. Any remaining molecules are bound in the molecular structure of the sintered restoration." This indicates that its performance is assessed by its benign interaction with the primary device.

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

The document does not specify the exact sample sizes (number of units tested) for each physical property test. It mentions that "The device has been designed and tested in accordance with ISO 6872:2008 Dentistry: Ceramic Materials for Flexural Strength, Chemical Solubility, Co-efficient of thermal expansion and Radioactivity." ISO standards typically define the minimum number of samples required for testing.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" in the context of clinical studies. Given this is a BMM (biomaterial) device, the testing would have been conducted in a laboratory setting by the manufacturer (Wieland Dental + Technik Gmbh & Co. Kg).

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

This information is not applicable to this type of device submission. The "ground truth" for material properties is established through standardized laboratory testing protocols (e.g., ISO 6872:2008), not through human expert consensus or clinical assessment in the same way an AI diagnostic device would.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret data, and their disagreements are resolved. For material property testing, the results are quantitative measurements against established standards.

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. An MRMC study is relevant for AI-assisted diagnostic devices involving human interpretation of medical images or data. This submission is for dental ceramic materials, not an AI or diagnostic device.

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

This information is not applicable as the device is a material, not an algorithm.

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

The "ground truth" for this device, in terms of its properties, is established by standardized laboratory testing and measurements based on international standards (ISO 6872:2008). The expectation is that the material properties meet or exceed the requirements of these standards and are equivalent to the predicate device.

8. The sample size for the training set

This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical material, not a software algorithm.

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

This information is not applicable as there is no training set for a machine learning model.

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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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"ZENO Zr Disc" is a group of medical devices, which is intended to fabricate allceramic dental restorations like crowns and bridges. It consists of ceramic blanks and colorina liquids.

"ZENOTEC Zr Bridge" and "ZENOSTAR Zr translucent" are yttria stabilized zirconium dioxide (Y-TZP) ceramic (zirconia) blanks for the CAD/CAM-production of dental restorations.

"ZENOTEC Color Zr" and "ZENOSTAR Color Zr" are coloring liquids for the shading of white zirconia ceramic materials.

The products are intended to be used by professional dental technicians for fabrication of all-ceramic single tooth and bridgework restorations, with one or two pontics, in the anterior as well as in the posterior tooth region.

ZENO Zr Disc is a group of medical devices, which is intended to fabricate allceramic dental restorations like crowns and bridges. It consists of two various materials:

1.) "ZENOTEC Zr Bridge" and "ZENOSTAR Zr Translucent" are discoidal shaped and partially sintered dental ceramic materials that are composed of yttria (yttrium oxide) stabilized zirconium dioxide (Y-TZP). Both models are available in various colors, translucencies and thicknesses.

They are provided as pre-sintered blanks, which are ready to be processed in a milling machine with the CAD/CAM technology to get the desired shape, and has then to be sintered at high temperature to its full density, in order to achieve the wellknown, excellent effectiveness and safety of the zirconia.

Sintered ZENO Zr Disc materials are biocompatible, insoluble in water and have extremely high strengths. which makes it possible to manufacture delicate and filigree all-ceramic frameworks and restorations. This, together with the various available colors and translucencies of the zirconia materials, offers the basis for aesthetically pleasing, safe and effective dental restorations.

ZENO Zr Disc meets all applicable requirements of the standard ISO 6872: 2008 "Dentistry - Ceramic materials".

2.) "ZENOTEC Color Zr" and "ZENOSTAR Color Zr" are coloring liquids, which consist of watery, acidic metal salt solutions. They are intended to be used for the individual staining of dental zirconia frameworks and restorations.

They are provided in various shades. respectively. which are corresponding to every tooth color. For staining, the zirconia materials have to be immerged into the liguids (ZENOTEC Color Zr) or to be brushed with the liguids (ZENOSTAR Color Zr), before sintering at high temperatures.

Staining with ZENOTEC Color Zr or ZENOSTAR Color Zr does not have any impact on safety and efficiency of the zirconia, but only match the color of the material.

The ZENO Zr Disc device is intended for fabricating all-ceramic dental restorations such as crowns and bridges, with the aid of CAD/CAM technology. The device consists of yttria-stabilized zirconium dioxide (Y-TZP) ceramic blanks (ZENO Zr Bridge and ZENOSTAR Zr Translucent) and coloring liquids (ZENOTEC Color Zr and ZENOSTAR Color Zr).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify a separate "test set" with a defined sample size in the context of a clinical study or performance verification using patient data. The claims of meeting acceptance criteria are based on bench testing against ISO standards and comparison to predicate devices.

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

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. The validation relies on technical specifications and established standards for dental ceramic materials.

4. Adjudication method for the test set:

This information is not applicable as there is no described test set requiring adjudication in the context of human interpretation or classification.

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 is a dental material, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

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

This is not applicable. The device is a dental material, not an algorithm. Its performance is inherent in its material properties and manufacturing process, not through an algorithm.

7. The type of ground truth used:

The ground truth used for establishing the acceptance criteria of ZENO Zr Disc is based on:

• International Standard ISO 6872: 2008 "Dentistry - Ceramic materials": This standard defines the performance requirements for dental ceramic materials, including properties like strength, biocompatibility, and solubility.
• Predicate devices: The device's performance is also compared to legally marketed predicate devices (Cercon base (K013230) and LAVA Frame; LAVA Frame Shade; LAVA Ceram (K011394)) to establish substantial equivalence in terms of material constituents, application process, biocompatibility, chemical solubility, and other technical performances.

8. The sample size for the training set:

This information is not applicable. The document does not describe a "training set" as this device is not an AI/ML algorithm that requires training data.

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

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

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Zenoflex dimension is a dental ceramic, which is suitable for veneering hard-sintered zirconium dioxide frameworks with a coefficient of thermal expansion (CTE 25-500°C) of approx. 10.5 x 10° K 1.

Zenoflex dimension is a dental porcelain system that consists of about 150 different ceramic powders and it is intended to be used by professional dental technicians to manufacture all-ceramic dental appliances for the sole use of particular patients. Zenoflex dimension is recommended for veneering zirconium dioxide (ZrQs) frameworks with a coefficient of thermal expansion [CTE ¿25-500°C]] of approximately 10,5 x 10° Ki¹.

The Zenoflex dimension ceramic offers the dental technician the possibility to chose between different kinds of laver techniques considering aesthetical and economical aspects.

The "One layer technique", which is a fast and simple procedure to manufacture ceramic restorations, considers primarily the economical aspects. For manufacturing ceramic restorations the user needed numerous types of ceramic (dentine and incisal ceramics) so far. But now less types of ceramic are necessary for manufacturing anatomical crowns or bridges and for achieving the desired dental colour.

The "Three layer techniques" enable the user to achieve a dental restoration with a more aesthetical result, because this layer technique comprises the application of at least three different types of ceramic.

With the "Professional layer technique" the dental technician can carry out an extended professional build-up to achieve a dental restoration with the most aesthetical result.

Furthermore the Zenoflex dimension ceramic enables the user to manufacture dental restorations with colours of the "VITA Toothguide Classical" as well as of the "VITA Toothguide 3D-Master".

This is a 510(k) summary for a dental ceramic device (Zenoflex dimension). The provided document does not contain the sort of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would be found in a study report for device performance evaluation as typically done for AI/ML-enabled medical devices.

The document outlines the device description, intended use, and comparison to a predicate device (Zirox) to establish substantial equivalence. The comparison focuses on physical, biological, and chemical properties tested according to international standards (e.g., ISO 6872, ISO 7405).

Therefore, it's not possible to populate the requested table and answer the study-related questions beyond what is explicitly stated for material properties.

Here's an attempt to answer based on the provided text, highlighting what is not available:

1. 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)

• Not specified. The document mentions testing "according to international accepted standards" but does not detail the specific test sample sizes or data provenance for these material property tests.

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 device is a dental ceramic, and the ground truth for its performance is based on physical, chemical, and biological testing against established international standards, not interpretations by human experts in the context of diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

• No. This is not an AI/ML-enabled device, and no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML device.

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

• The ground truth for the device's properties is established by international standards such as ISO 6872 (for physical and chemical properties of dental ceramics) and ISO 7405 (for biocompatibility of medical devices). The device's performance is measured against the specifications outlined in these standards.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance data relates to material properties derived from experimental testing against standards.

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

• Not applicable. See point 8.

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The spray glaze ZENOSTAR Magic Glaze is a ready to use and easy to apply, spray on ceramic glaze, which is primarily intended for ZENOSTAR Zr restorations, manufactured with the help of the ZENOTEC Systems. However, veneered zirconium oxide restorations, (ZIROX and ZENOFLEX dimension) and metal ceramic restorations (REFLEX and REFLEX dimension) can also be glazed with the spray glaze ZENOSTAR Magic Glaze. ZENOSTAR Magic Glaze spray glaze can be used together with and/or at the same time as the relevant specific ceramic stains.

ZENOSTAR Magic Glaze is dental porcelain, which is made of glass frit and is applied in an aerosolized form. It can be used by professional dental technicians to glaze dental porcelain -fused-to-metal as well as all-ceramic restorations, like milled zirconium dioxide crowns and bridges.

This application method decreases the production time compared to the conventional build-up methods, where glaze ceramic powder has to be mixed with suitable liquids and layered onto the restoration with a brush.

After spraying on, ZENOSTAR Magic Glaze has to be fired at about 900°C for 1-2 minutes in a ceramic furnace to achieve its final properties.

Generally, the glaze bake determines the surface finish of the ceramic veneer and thereby significantly affect the esthetical appearance of the restoration. ZENOSTAR Magic Glace allows spraying on even and very thin layers of glace material, thus providing the possibility to control shining and optical reflection of the restoration by repeating the procedure.

It can be applied on single unit or multiple unit restoration at one time, and, in addition, it can be sprayed over unfired ceramic stains and body-stains, which are often used to match the color of the patient's natural teeth. These possibilities save time of additional firing cycles and enhance the efficiency of the application of ZENOSTAR MAGIC Glaze.

The provided text is a 510(k) summary for ZENOSTAR Magic Glaze, a dental ceramic spray glaze. It details the device's description, intended use, and comparison to a predicate device for the purpose of demonstrating substantial equivalence.

However, the document does not contain specific acceptance criteria for performance metrics, nor does it detail a study that proves the device meets such criteria in terms of quantitative performance (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance).

Instead, the document asserts substantial equivalence based on the device's physical, biological, and chemical properties meeting demands of international accepted standards (like ISO 6872 for bending strength, and ISO 7405 for biocompatibility).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text because such specific performance criteria and a study to prove them are not present. The document focuses on demonstrating equivalence through material properties and intended use.

Here's a breakdown of what can be extracted or inferred based on the questions, even if direct answers for performance criteria and a specific study are absent:

1. Table of Acceptance Criteria and the Reported Device Performance:

   Acceptance Criteria (Inferred from standards)	Reported Device Performance (Inferred from compliance statements)
   Meets ISO 6872 (Bending Strength)	"meet their demands"
   Meets ISO 7405 (Biocompatibility)	"meet their demands"
   Meets standards for Chemical Solubility	"meet their demands"
   Safe and Effective	"as safe, as effective, and performs as well as or better than the predicate device."

   Note: The document only generally states that the device meets the "demands" of these standards, without providing specific numerical thresholds for acceptance or the measured values of the ZENOSTAR Magic Glaze.

2. Sample size 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 given text.

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 in the given text. This type of evaluation is not relevant for a materials science submission like this.

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

   • This information is not provided in the given text. This type of evaluation is not relevant for a materials science submission like this.

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 provided in the given text. This device is a material (ceramic spray glaze), not an AI-assisted diagnostic tool.

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

   • This information is not provided in the given text. This device is a material, not an algorithm.

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

   • For a material like dental porcelain, the "ground truth" for its properties (bending strength, biocompatibility, chemical solubility) would typically be established through laboratory testing according to established international standards (e.g., ISO 6872, ISO 7405). These standards define the test methods and performance requirements. The text explicitly mentions compliance with these standards.

8. The sample size for the training set:

   • This information is not provided in the given text. This is not relevant for a materials science submission, as there is no "training set" in the machine learning sense.

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

   • This information is not provided in the given text. This is not relevant for a materials science submission.

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ZENO® Al cco Discs are milling blanks from which single copings and primary components for anteriors and premolars can be made. These are intended for use as ceramic frameworks for dental prosthetics.

ZENO Al eco Discs are milling blanks composed of pure aluminium oxide. They are intended to be used by professional dental technicians for making single copings and primary components for anteriors and premolars to apply them as ceramic frameworks for dental prosthetics for the sole use of particular patients. ZENO Al eco Discs can be machined in all machines of the ZENO Tec system. The manufacturing process of this ceramic framework consists of different steps. At first the model has to be scanned. In the next step, the restoration has to be designed virtually with the help of the CAD technology. Thereafter, the realization of this design has to be carried out by the CAM technology. In a final step after hard sintering of the ZENO Al eco, the framework can be veneered with a suitable veneering ceramic.

This document is a 510(k) summary for the ZENO Al eco Disc, a dental milling blank. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial with acceptance criteria for a new AI/software device. Therefore, many of the requested categories related to AI performance studies are not applicable or cannot be extracted from this document.

Here's an analysis of the provided text in relation to your request:

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

This document does not specify quantitative acceptance criteria or device performance data in the way an AI/software device submission would. Instead, it relies on demonstrating equivalence to a predicate device based on material properties and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A. This is a material-based dental device, not an AI/software device requiring a test set of data for performance evaluation. The submission relies on laboratory testing of material properties, not a "test set" of patient 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)

N/A. Not applicable to this type of device submission. Ground truth, in the context of AI, involves expert-level annotations or diagnoses, which is not relevant here.

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

N/A. Not applicable to this type of device submission.

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

N/A. This is not an AI-powered device.

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

N/A. This is not an AI-powered device.

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

For a material-based device like this, "ground truth" typically refers to established standards for material properties (e.g., strength, biocompatibility) as assessed through standardized laboratory tests. The document implies that these properties were tested and found to be comparable to the predicate device, but specific details of these tests are not provided in the summary.

8. The sample size for the training set

N/A. This is not an AI/machine learning device. The "training" for such a device would involve optimizing the manufacturing process to achieve desired material properties, not training an algorithm on a dataset.

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

N/A. Not applicable to this type of device submission.

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ZENO®PMMA Discs are milling blanks consisting of polymethylmethacrylate. They are designed for making long-term temporary crown and bridge work and have to be machined with the CAD/CAM technique. ZENO PMMA Discs are recommended for manufacturing substructures of single tooth and bridgework with one or two pontics.

ZENO PMMA Discs (A3/B1) are milling blanks composed of hot cured polymethylmethacrylate (PMMA). They are intended to be used by professional dental technicians for making long-term temporary crowns and bridgeworks for the sole use of particular patients.

ZENO PMMA Discs can be machined in all machines of the ZENO Tec system. The manufacturing process of the long-term temporary crowns and bridges consists of different steps. At first the model has to be scanned. In the next step, the restoration has to be designed virtually with the help of the CAD technology. Thereafter, the realization of this design has to be carried out by the CAM technology. In a final step the restoration can be individually characterised with dental veneering composites for improving the aesthetics and it can be pre- and high shine polished.

The ZENO PMMA Discs are offered in two different shades (A3, B1) and thicknesses.

The provided document is a 510(k) summary for a dental device (ZENO PMMA Disc). It does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets specific performance criteria.

Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (VITA CAD-TEMP). This is a different regulatory pathway than providing detailed performance studies against defined acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document. However, I can provide what information is available based on the request:

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

• Not Applicable: The document does not provide specific acceptance criteria or performance data for the ZENO PMMA Disc. It asserts "comparable physical, biological, and chemical properties" to the predicate device but does not quantify these or establish specific criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable: No clinical or laboratory performance study against specific criteria is described, so no test set sample size or data provenance is mentioned.

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: No ground truth establishment activity for a test set is described.

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

• Not Applicable: No adjudication for a test set is described.

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 material science device, not an AI or imaging device, so an MRMC study is irrelevant and not mentioned.

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

• Not Applicable: This is a material science device, not an algorithm.

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

• Not Applicable: No ground truth used for performance evaluation is described. The "ground truth" for regulatory submission in this case is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not Applicable: This is a material science device, not an algorithm that requires a training set.

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

• Not Applicable: As above, no training set or ground truth for it is relevant or mentioned.

Summary of available information related to equivalence, as described in the document:

The regulatory submission asserts substantial equivalence based on:

• Identical indication for use: ZENO PMMA Discs and the predicate (VITA CAD-TEMP) are both used for making long-term temporary crowns and bridgeworks.
• Comparable material properties: Both devices are acrylate polymers and "have comparable physical, biological, and chemical properties." (No specific data provided in this summary to quantify "comparable").
• Similar function: Both devices have the "same prophylactic, diagnostic and aesthetic function."

The document states: "Due to the high polymerization grade and excellent material properties of the ZENO PMMA Discs, the restorations possess a high-level safety and effectiveness. ZENO PMMA Discs therefore are as safe, as effective, and performs as well as or better than the predicate device." This is the core argument for substantial equivalence rather than a detailed performance study against acceptance criteria.

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