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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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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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