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Types of restorations:

1. Anterior and posterior crowns
2. Veneers, inlays, onlays.

zirconia layering porcelain system layering ceramic powders and pastes are used in dental laboratories by the dental technician to create ceramic restorations.

The provided FDA 510(k) clearance letter and summary are for "zirkon; structure; LFU shades, stains and glazes," which are dental ceramic materials (porcelain powder for clinical use), not a medical device that relies on an algorithm or AI for diagnostic or treatment assistance. Therefore, the document does not contain any information regarding acceptance criteria related to device performance in the context of AI/algorithm a medical device, nor does it describe a study to prove such performance.

The "acceptance criteria" and "study" described in the input prompt are typically associated with AI/ML-based medical devices or diagnostic tools where performance metrics like sensitivity, specificity, or reader improvement are critical for demonstrating safety and effectiveness.

The information provided in the FDA document focuses on the equivalence of the dental ceramic materials to a predicate device based on:

• Intended Use: Types of dental restorations (crowns, veneers, inlays, onlays).
• Technological Characteristics: Physical state (powder/paste), material composition (silicate glass ceramics), and classification according to ISO 6872:2019.
• Bench Testing: Compliance with physical properties (flexural strength, chemical solubility, thermal expansion, glass transition temperature, radioactivity) and biocompatibility according to ISO 7405:2018 and ISO 10993:2018.

Therefore, it is impossible to extract the requested information (table of acceptance criteria with device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text, as these concepts are not applicable to the type of device described.

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ZIRKONZAHN.Implant-Planner is an implant planning software. The software imports and reads DICOM files from CT/CBCT scanners. The patient data is then transformed into 3D volume and different multi-planar 2D images for diagnosis and further implant and surgery guide planning with precise step by step instructions. The software is a stand-alone product that is not connected to any other medical device. Neither automatic diagnosis nor automatic disease detection is performed. The software is intended for use by dental professionals only and requires appropriate training for its use and knowledge in the practice of implantology.

ZIRKONZAHN.Implant-Planner is a fully-featured 3D imaging standalone application for implant planning and surgical guide design. ZIRKONZAHN.Implant-Planner supports all the common 3D medical imaging functionalities used by professionals to support their diagnosis. It includes various volume and surface rendering, masking and sculpting, MPR, 2D and 3D measurement and analysis tools. The software is provided in 2 versions and 2 modules: the first version is a full version (called "ZIRKONZAHN.Implant-Planner") that covers all applications for use, the second version is a basic/limited version (called "ZIRKONZAHN.Implant-Planner Practice") only for implant planning. The first module is a CAD/CAM STL Converter that converts DICOM data into STL files for further processing. The second one is the CAD/CAM Z-Tray for designing individual impression trays.

The provided text describes the ZIRKONZAHN.Implant-Planner, an implant planning software. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets these criteria in the format requested.

The document states that "Software verification and validation is performed in accordance with the procedures described in this submission and in accordance with the applicable FDA guidelines. Code review, unit, integration and system testing were conducted to establish the functionality characteristics of the subject device. Software validation confirms that the particular requiremented through software are consistently fulfilled. Implemented controls such as collision detection related to device hazards identified in the risk management procedures are validated to establish the safety of the device. Bench tests demonstrate the accuracy of critical items in the whole workflow of the device. The tests performed on the single items report satisfying results that back up the accurate performance of the new device for its achieved outputs when used as intended. The accuracy of data elaboration with its relative outcomes will ensure a safety placement of the clinical use and a positive impact on the overall healthcare situation."

It also explicitly states, "Clinical testing is not a requirement and has not been performed."

Therefore, I cannot provide the requested information in the specified format because the input text does not contain it.

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Zircon Blanks are used for milling using digital stl-files to produce Crowns, Bridges and monolithic works. We propose the K2 Zircon Blanks for anterior and posterior restorations.

Table 1: Indication of use and maximum intermediate elements.

All K2 Zircon Blanks are indicated to be colored with Dip & Brush K2 CAD CAM Zircon Liquids. K2 Zircon Blanks should be not used by the general public or over-the-counter.

The Yeti K2 Zircon Blanks are ceramic blanks, which are indicated for the production of dentalprosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology and for milling using digital STL files to produce Crowns, Bridges and monolithic works made from zirconium oxide.

The Yeti Dip & Brush K2 liquids are ready for use water-based products. These liquids are specifically formulated for the colorization of K2 Zircon Blanks from Yeti Dentalprodukte GmbH.

This document is a 510(k) premarket notification for a dental device, specifically Zirconium Oxide blanks used for milling dental restorations. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) is not applicable to this type of submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific acceptance criteria in the form of performance thresholds (e.g., in terms of accuracy, sensitivity, or specificity) for the device itself in a study format. Instead, it demonstrates substantial equivalence to predicate devices based on:

Note: The document explicitly states: "Except for the K2 Zircon Blank white classic, there was no comparable value found for the specifications translucency and Thermal conductivity" for the predicate device. This indicates that for these specific properties, direct comparison was not possible, but it doesn't indicate a failure to meet acceptance criteria, as the overall substantial equivalence argument is based on the totality of characteristics.

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

This document describes a 510(k) submission for a dental material (zirconium oxide blanks), not an AI/software device. Therefore, there is no "test set" in the context of an AI study for diagnostic performance. The "tests" mentioned are material property tests and biocompatibility tests.

• Sample Size: Not specified in terms of a "test set" as understood in AI studies. The performance data refers to "bench test for each raw material or product batch" and "biocompatibility evaluation." The number of samples for these tests is not quantified in the provided text, but it implies ongoing quality control and a specific evaluation for biocompatibility.
• Data Provenance: Not applicable in the context of clinical data for AI; the data refers to material testing conducted by the manufacturer, Yeti Dentalprodukte GmbH, in Germany. The biocompatibility tests were conducted according to ISO 10993-1.

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 device is a dental material, not a diagnostic device requiring expert interpretation or ground truth establishment in the diagnostic sense. The "ground truth" for material properties is established through standardized physical and chemical tests (e.g., ISO standards, lab measurements).

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

This section is not applicable. There is no "test set" for diagnostic performance and no human interpretation requiring adjudication in this 510(k) 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

This section is not applicable. An MRMC study is relevant for comparing human reader performance with and without AI assistance for diagnostic tasks. This device is a dental material, not an AI diagnostic tool.

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

This section is not applicable. This device is a dental material, not an algorithm.

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

The "ground truth" for this device relates to its physical, chemical, and biological properties. This is established through:

• Standardized material testing: Measurements of properties like chemical composition, bulk density, grain size, flexural bending strength, fracture toughness, hardness, coefficient of thermal expansion, radioactivity, and solubility. These are objective laboratory measurements, not subjective expert consensus.
• Biocompatibility testing against ISO standards: Compliance with ISO 10993-1, which involves specific tests for cytotoxicity, haemolysis, etc.

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is a material rather than an AI or machine learning algorithm.

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

This section is not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it is irrelevant in this context.

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For the fabrication of metal free single and multiple unit crowns/bridges, inlays, onlays bonded dental restorations.

ICE Zirkon Transluzent Plus is a dental porcelain system composed of zirconia based blocks which utilizes CAD/CAM technology for dental restoration fabrication.

This document is a 510(k) submission for a dental material (ICE Zirkon Transluzent Plus), not an AI device. Therefore, the requested information regarding acceptance criteria and studies for an AI device cannot be extracted from this document. The document describes the equivalence of the new dental material to a predicate device based on material properties and established standards, not an AI algorithm's performance.

However, I can provide the information available about the dental material from the document, interpreted through the lens of device performance for that material:

1. Table of Acceptance Criteria and Reported Device Performance

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

• This document describes testing of a physical dental material, not a software device or an AI model. Therefore, "test set" and "data provenance" as typically understood for AI models are not applicable.
• The testing performed would be on physical samples of the ceramic material. The document does not specify the number of samples used for each test (flexural strength, solubility, etc.).
• Data provenance: Not directly described, but the company is Zirkonzahn, GmbH, located in Gais, Italy. The testing would have been performed by or for the manufacturer. This is a prospective evaluation of a new material.

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 is not applicable to a physical dental material. "Ground truth" for this device refers to objective material properties measured against established international standards (like ISO 6872:2008), not expert consensus on interpretations of images or data.

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

• Not applicable for a physical material. Material properties are measured according to standardized protocols, not adjudicated by experts in the same way as clinical assessments or model outputs.

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 as this is not an AI device.

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

• Not applicable as this is not an AI device. The "device" itself is the ceramic material. Its performance is inherent in its physical and chemical properties.

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

• For this dental material, the "ground truth" for its performance is based on measurements against established international standards and validated testing methodologies (e.g., ISO 6872:2008 for flexural strength, chemical solubility, radioactivity). It's an objective measurement of a material's properties.

8. The sample size for the training set:

• Not applicable as this is not an AI device. There is no "training set" for physical material properties.

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

• Not applicable as this is not an AI device.

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BeCe CAD Zirkon HT+ is indicated for the fabrication of single crowns and bridgework.

• Fully anatomical crowns and bridges -
• Partial-veneered and fully veneered crowns and bridges -
• Dentine core crowns and bridges -
• Maryland bridges -
• Telescopic crowns (primary part) -

BeCe CAD Zirkon HT+ consists of yttria stabilized zirconia and is suitable for the fabrication of dental ceramic restorations. BeCe CAD Zirkon HT+ is available as milling blank and is processed by milling technique.

The provided text describes a dental product, "BeCe CAD Zirkon HT+", and its substantial equivalence to a predicate device based on meeting certain industry standards. However, it does not contain information about acceptance criteria for an AI/ML device, a study proving an AI/ML device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) summary for a dental material (zirconia powder), not an AI/ML device. Therefore, it does not address any of the specific points requested in the prompt regarding AI/ML device evaluation.

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The Zirkondent is indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses.

Not Found

The provided document is a 510(k) clearance letter for a dental device called "Zirkondent," which is a porcelain powder for clinical use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI assistance.

The letter confirms that the FDA has reviewed the device's premarket notification and determined it to be substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory compliance and the permission to market the device, rather than detailed performance study results.

Therefore, I cannot fulfill your request for the information outlined in your prompt based on the provided text.

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Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays bonded dental restorations.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device named "Zirkonzahn Ice," which is classified as "Porcelain Powder for Clinical Use." This document primarily deals with the administrative notification and clearance process rather than detailed study results or acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from this document. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, not necessarily a demonstration of meeting specific performance criteria through a new study.

The document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number or qualifications of experts used to establish ground truth.
• Adjudication method for a test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results from a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

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HeraCeram Zirkonia dental ceramic compound is intended for use with the rieraeona crown and bridge framework made of zirconia.

Not Found

I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a US FDA 510(k) clearance letter for a dental ceramic product called "HeraCeram Zirkonia." This letter primarily addresses the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory requirements. It does not contain:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test sets or their data provenance.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information about standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets and how their ground truth was established.

These types of details would typically be found in the 510(k) submission itself, which is a much more extensive document than the clearance letter provided. The clearance letter only states that the device was found "substantially equivalent" based on the information in the submission.

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Intended for preparation of crowns, facings, veneers, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish.

For fabricating copings and frameworks for inlays, veneers, crowns, anterior and posterior bridge restorations.

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Cynovad Zirkon™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Cynovad Zirkon™ inlays are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, except that their application more closely resembles gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

This submission describes a dental restorative material, "Cynovad Zirkon™", which is a zirconium dioxide-yttrium oxide ceramic used to create inlays, onlays, veneers, and crowns. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with specific acceptance criteria and performance metrics for the device itself.

Therefore, many of the requested sections (Table of acceptance criteria and performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone study, ground truth type and training set information) cannot be extracted from the provided text as the information is not present.

Here's a breakdown of what can be inferred or stated from the provided document:

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

The document does not specify quantitative acceptance criteria or performance metrics for the Cynovad Zirkon™ device. The entire submission is based on demonstrating substantial equivalence to legally marketed predicate devices, meaning its performance is considered acceptable if its technological characteristics and intended use are similar to those already cleared.

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. There is no mention of a dedicated "test set" or a study designed to measure performance against specific criteria. The submission relies on a comparison to predicate devices.

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 for a test set is described.

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

Not applicable. No adjudication method is mentioned as there is no human review of a test set described in the context of performance evaluation.

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 material for dental restorations, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI is not relevant.

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 (expert consensus, pathology, outcomes data, etc)

Not applicable. The basis for clearance is substantial equivalence to predicate devices, not direct comparison to a clinical ground truth established through expert consensus, pathology, or outcomes data for the Cynovad Zirkon™ itself. The "ground truth" in this context is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. As a material, there is no "training set" in the context of algorithm development.

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

Not applicable. See point 8.

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