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Polibond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases.

The Subject device is a single-component self-cure bonding agent intended for use with milled PMMA denture base resins and milled PMMA denture teeth. The Subject device is used by a dental professional (dentist or dental technician) in the fabrication or repair of removable dentures. Dentures fabricated using the Subject device are one-time use, prescription-only devices. Polibond is intended for bonding Zirkonzahn PMMA materials such as Abro® Basic Multistratum® and Denture Gingiva Basic Mono resins in the manufacturing of dental prostheses. Abro® Basic Mono and Abro® Basic Multistratum® are dentin colored and used for milling denture Gingiva Basic Mono is a material used for milling denture bases.

Here's the information about the acceptance criteria and the study that proves the device meets the acceptance criteria, extracted from the provided text:

Device: Polibond (Denture relining, repairing, or rebasing resin)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample sizes used for the non-clinical performance testing (e.g., number of samples for tensile strength, biocompatibility, or shelf-life tests).
• The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but it is implied to be prospective as these are tests conducted specifically for the device's premarket notification.

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 describes non-clinical performance testing of a material, not a diagnostic or AI-driven device that requires expert-established ground truth. The acceptance criteria are based on established ISO standards and direct measurements.

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

• None. This is not relevant for the type of non-clinical material testing described. Results are derived from physical and chemical measurements against predefined 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:

• No. This type of study is not mentioned and is not relevant for the assessment of this particular device (a dental bonding agent).

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.):

• The "ground truth" for this device's performance is established by objective measurements against recognized international standards (ISO 20795-1, ISO 10993 series) and comparative testing against a legally marketed predicate device for tensile strength.

8. The sample size for the training set:

• Not applicable. This device is a material, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is a material, not an AI/ML algorithm.

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ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICS DENTINE +, ICE CERAMICS DYNAMIC DENTINE, FRESCO ENAMEL, FRESCO GINGIVA, FRESCO, FRESCO DENTINE + and FRESCO DYNAMIC DENTINE are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.
ICE STAINS, ICE STAINS PRETTAU®, ICE STAINS GLAZE FLUO and ICE STAINS 3D are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.

All devices included in this submission are dental glass ceramics. There are different device types from three device groups: ICE Ceramics Group, ICE Stains Group, and Fresco Group. The devices are supplied in form of powders or pastes and are available in different colors and/ or in different quantity sizes. Specific accessories are supplied for mixing or changing viscosity.

The provided text describes a 510(k) premarket notification for dental glass ceramics (ICE Ceramics, ICE Stains, Fresco) and includes non-clinical testing data to establish substantial equivalence to a predicate device. However, it does not describe a study involving human readers or AI assistance, nor does it present acceptance criteria in terms of diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested items cannot be answered from the provided document. The device in question is a dental material, not an AI-powered diagnostic tool.

Here's what can be extracted and what cannot:

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

The acceptance criteria are presented as performance requirements according to the relevant ISO standards for dental ceramics.

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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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PRIME is used for manufacturing provisional crowns and bridge frameworks with up to two adjacent pontics in the anterior and posterior tooth area.

ABRO 1 is intended for the fabrication of denture teeth; RESITON GINGIVA is intended for the fabrication of denture bases.

PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.

The subject devices are blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental restorations. The devices are supplied in form of solid discs.

All devices are composed of the same basic material, Polymethylmethacrylate (PMMA), and are available in various models that differ in color and dimension.

The materials used for the submitted devices have a long history of safe use for the same or equivalent indications.

This document is a 510(k) Premarket Notification from Zirkonzahn srl to the FDA for their dental polymer blanks (discs) named ABRO 1, RESITON GINGIVA, PRIME, and THERAPON TRANSPA. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (UNION DENTAL S.A.'s IDODENTINE blanks) rather than proving the device meets specific performance acceptance criteria through a clinical study involving human patients or complex AI models.

Therefore, many of the requested criteria for describing a study proving the device meets acceptance criteria are not applicable to this type of regulatory submission for a medical device that is a material for dental restorations.

Here's a breakdown based on the provided document:

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

The document refers to performance testing according to ISO 10477:2018 and states that "All tested samples meet the requirements of the standard and show similar values as the predicate device."

The comparison table on page 5 provides specific physical property values for both the new devices and the predicate, with acceptance being meeting standard requirements and showing similarity.

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Zirkonzahn COLOUR LIQUID is used for coloring pre-sintered zirconia structures.

Zirkonzahn COLOUR LIQUID devices are used for coloring milled and finished presintered zirconia structures. Coloring is performed by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400 ℃.

The Zirkonzahn COLOUR LIQUIDS are available in different colors and in different bottle sizes (20 ml, 50 ml, 100 ml).

This document is a 510(k) Pre-market Notification for a dental device (Color Liquid, Vita Liquid). It establishes substantial equivalence to a predicate device, meaning it does not require a complex efficacy study with acceptance criteria and a human-in-the-loop study as would be required for an AI/ML device or a novel high-risk device.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical tests demonstrating that the coloring liquid does not negatively impact the functionality or biocompatibility of the zirconia structures it's applied to, and that the product is stable over its stated shelf life.

Here's a breakdown of the available information in relation to your request, highlighting what is provided and what is not applicable to this type of submission:

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

The document mentions non-clinical tests to evaluate physical properties, shelf life, and biocompatibility. However, it does not provide specific acceptance criteria or quantitative results in a table format. It generally states that "The results show that the devices are well suited for their intended use."

The relevant sections are:

• Section 05, "DISCUSSION OF NON CLINICAL TESTS" (page 5):
  • "Non-clinical testing was performed to evaluate the physical properties of colored zirconia compared to untreated zirconia, to demonstrate that the subject device does not negatively impact the functionality of the zirconia. The results show that the devices are well suited for their intended use."
  • "Furthermore, to establish the shelf life and storage conditions of the subject devices, real time aging was performed (including evaluation of color, workability and appearance) according to Zirkonzahn internal test protocols."
  • "Biocompatibility was established in consideration of the International Standard 10993-1:2010 'Biological Evaluation of Medical Devices' Part 1: Evaluation and Testing."

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

• Sample Size: Not specified for any of the non-clinical tests (physical properties, aging, biocompatibility).
• Data Provenance: The tests were performed by Zirkonzahn ("Zirkonzahn internal test protocols" and "Zirkonzahn performed biocompatibility testing"). The country of origin for the data is implicitly Italy, where Zirkonzahn srl is located. These are laboratory tests, not clinical data from patients (retrospective/prospective).

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

• Not applicable in the context of this device. The "ground truth" for the non-clinical tests would be defined by standardized test methods or internal protocols (e.g., measuring physical properties according to a standard, chemical analysis for biocompatibility). There are no human "experts" establishing clinical ground truth for image interpretation or diagnosis, as this is not an AI/ML diagnostic device.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert reads of medical images, to resolve discrepancies and establish a consensus ground truth. This document describes laboratory testing for a dental material.

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 not an AI/ML device or a device requiring a clinical effectiveness study with human readers. It's a coloring liquid for dental zirconia.

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

• Not applicable. This is not an algorithm or software.

7. The type of ground truth used:

• The "ground truth" for the non-clinical tests would be based on:
  • Physical Property Measurements: Objective measurements against predefined specifications or baseline (untreated zirconia).
  • Real-time Aging: Evaluation of objective characteristics like color, workability, and appearance over time, compared to initial properties and established shelf-life criteria.
  • Biocompatibility: Results against established criteria from ISO 10993-1:2010 (e.g., cytotoxicity, sensitization, irritation tests for representative and worst-case mixtures). This is typically based on laboratory assay results.

8. The sample size for the training set:

• Not applicable. This document does not describe an AI/ML device that requires training data.

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

• Not applicable, as there is no training set for this device.

In summary, this 510(k) submission for a dental coloring liquid focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing of material properties, shelf-life, and biocompatibility, rather than clinical efficacy studies or AI/ML performance evaluation. Therefore, many of the requested details related to clinical trials, AI/ML performance metrics, and expert-based ground truth are not relevant or provided in this type of regulatory document.

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Prettau®, Prettau® 2 Coloured, Prettau® 2 Dispersive, ICE Translucent, ICE Premium, ICE Abutment, ICE Translucent Plus, ICE Translucent Plus Coloured, ICE Translucent Plus Dispersive and Z-White are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.

Prettau® 3, Prettau® 3 Coloured, Prettau® 4 Anterior®, Prettau® 4 Anterior® Coloured and Prettaw® 4 Anterior® Dispersive are destined for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products have to be categorized as class 4 according to ISO 6872.

The products have been developed for use with Colour Liquid, ICE Zirkon Stains and ICE Zirkon Stains and ICE Zirkon Stains 3D. Observe the relative instructions of use when using these products. The blocks are suitable for all milling units, which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.

The subject devices are composed of yttria-stabilized zirconia. They are available in different models that differ in form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications.

This document describes the premarket notification for PRETTAU®, ICE, and Z-WHITE zirconia blanks. It is not an AI/ML device, therefore the typical acceptance criteria and study data for such devices will not be present.

Here's a breakdown of the relevant information from the document, focusing on the "acceptance criteria" through the lens of a non-AI/ML medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (zirconia blanks for dental restorations), "acceptance criteria" are typically defined by recognized international standards for material properties, rather than performance metrics like sensitivity or specificity.

Study Proving Device Meets Acceptance Criteria:

The document states: "Non clinical testing was performed to determine the physical properties of the subject devices. In consideration of the International Standard ISO 6872 'Dentistry - Polymer-based crown and bridge materials', the devices were tested. All samples fulfil the requirements of the standard." It also mentions biocompatibility testing according to ISO 10993-1.

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

• Sample Size: The document does not specify the exact number of samples used for physical or biocompatibility testing. It generally refers to "all samples" fulfilling the requirements, which implies a sufficient number were tested to demonstrate compliance.
• Data Provenance: The testing was "non clinical testing," implying laboratory-based studies conducted by the manufacturer (Zirkonzahn srl. or an accredited lab on their behalf). The country of origin of the data is not explicitly stated but would presumably be related to where Zirkonzahn srl. is based (Italy) or where their testing facilities are located. The data is retrospective in the sense that it was collected prior to this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable to this type of device. The "ground truth" for material properties is established by adherence to published industrial and international standards (like ISO 6872) and objective physical and chemical testing methodologies, not by expert consensus or interpretations of images/data.

4. Adjudication Method

This concept is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretations (e.g., by radiologists or pathologists) to resolve discrepancies. Material property testing relies on objective measurements and established protocols.

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

This is not applicable to this type of device. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, typically for diagnostic or screening devices. This device is a material for dental restorations.

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the device is not an algorithm or AI system. It is a physical material (zirconia blanks).

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on established international standards (ISO series) for material properties (e.g., flexural strength, chemical composition, biocompatibility). These standards provide quantifiable criteria that the device must meet through objective physical and chemical testing.

8. Sample Size for the Training Set

This is not applicable as the device does not involve an AI/ML algorithm that requires a training set. The device is a manufactured material.

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

This is not applicable for the same reason as above; there is no AI/ML training set.

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TECNO MED MINERAL, TECNO MED MINERAL DENTINE and TECNO MED MINERAL TISSUE are used to create reduced crowns and bridges (max. 2 pontics and min. 13 mm² connection cross-section), telescopic primary crowns, copings as well as frameworks for composite veneered bridges. The width of the bridge must not exceed two pontics for reasons of stability.

TECNO MED is designed for the manufacturing of frictional elements on telescopic restorations or attachments.

Tecno Med and the three Tecno Med Mineral devices are tooth-shade polymer discs based on polyether ether ketone (PEEK). These discs are available in a variety of shapes for different milling systems. For each device, there are two diameter variants, 95 mm and 98 mm. The discs with a diameter of 98 mm are additionally available with or without step. Moreover, each model is provided in different heights (8mm-30 mm). The users can choose according to their requirements and preferences among the different models. Tecno Med Mineral, Tecno Med Mineral Dentine as well as Tecno Med Mineral Tissue have the same indications for use, for the Tecno Med device there are other indications for use.

These polymer discs are used by specifically trained personnel using CAD/CAM techniques.

The provided text is a 510(k) summary for dental resin materials (Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue). It does not describe an AI/ML medical device. Therefore, I cannot extract information related to acceptance criteria, study methods, ground truth establishment, or sample sizes as they pertain to AI/ML device performance.

The document focuses on demonstrating substantial equivalence to a predicate device (breCAM.BioHPP) through non-clinical performance testing of physical properties such as water absorption, water solubility, density, modulus of elasticity, flexural strength, and biocompatibility, as well as similarities in chemical composition, indications for use, and intended user.

A table of acceptance criteria and reported device performance (for an AI/ML device) cannot be created from this document.

The document details the following for the dental resin materials:

• Non-clinical performance tests conducted: In-vitro cytotoxicity, Skin sensitization, Irritation, Mutagenicity (all for Biocompatibility), and tests according to ISO 10477:2004 and DIN EN ISO 20795-2:2013 for physical properties.
• Reported device performance (physical properties):
  • Melting Temperature: Approx. 340 °C (for Tecno Med Mineral, Tecno Med, and predicate)
  • Water absorption (µg/mm³):
    • Tecno Med Mineral: 7.3
    • Tecno Med Mineral Dentine: 6.5
    • Tecno Med Mineral Tissue: 7.2
    • Tecno Med: 4.73
    • Predicate (breCAM.BioHPP): 6.5
  • Water solubility (µg/mm³):
    • Tecno Med Mineral: 1.2
    • Tecno Med Mineral Dentine: 0.6
    • Tecno Med Mineral Tissue: 1.2
    • Tecno Med: 1.67
    • Predicate (breCAM.BioHPP): 0.1
  • Density (g/cm³):
    • Tecno Med Mineral: 1.49
    • Tecno Med Mineral Dentine: 1.52
    • Tecno Med Mineral Tissue: 1.36
    • Tecno Med: 1.31
    • Predicate (breCAM.BioHPP): 1.44
  • Modulus of elasticity (MPa):
    • Tecno Med Mineral: 4100
    • Tecno Med Mineral Dentine: 4400
    • Tecno Med Mineral Tissue: 5100
    • Tecno Med: ≥ 4300
    • Predicate (breCAM.BioHPP): 4585
  • Flexural strength (MPa):
    • Tecno Med Mineral: 201
    • Tecno Med Mineral Dentine: 198
    • Tecno Med Mineral Tissue: 189
    • Tecno Med: 174
    • Predicate (breCAM.BioHPP): 178
  • Biocompatibility: Established for all new devices and predicate.

None of the other requested information (sample size for test set/training set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for AI, how ground truth for training set was established) is relevant or present in this document as it pertains to AI/ML device evaluation.

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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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