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510(k) Data Aggregation
(139 days)
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
| Parameter | Acceptance Criteria (from ISO 6872:2008 for Class 5 material - 3 unit prostheses with molar restoration) | Reported Device Performance (Zenostar MT) |
|---|---|---|
| Flexural Strength | Minimum mean of 500 MPa | >550 MPa |
| Biocompatibility | In accordance with EN ISO 10993-1:2009, EN ISO 7405:2008, EN ISO 14971:2012 | Assessed and found equivalent to predicate devices |
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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(48 days)
Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.
Dental blanks made from StarCeram® products are semi finished products made of yttrium stabilized pre-sintered zirconium dioxide for milled production of crowns and bridge framework on commercial CAD/CAM systems or hand-operated copy-milling.
The provided text is for a 510(k) premarket notification for a dental blank device, StarCeram®, and primarily addresses substantial equivalence to predicate devices, not performance criteria in the context of an AI/ML medical device. As such, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.
Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific performance acceptance criteria for the device's output (e.g., diagnostic accuracy, sensitivity, specificity) are mentioned in this document. The submission focuses on substantial equivalence to existing predicate devices. | Biocompatibility and cytotoxicity testing showed that all versions of the product comply with ISO 10993-1, demonstrating the material's safety for use in the human body. |
| For the previously cleared StarCeram® Z-Med and Z-Al-Med HD (K081263), the only change to the cleared products is the additional indication for use related to all-ceramic restoration. All other aspects, including physical properties, remain unchanged. | (No specific performance data is provided for this added indication, relying on substantial equivalence to the original clearance.) |
| For StarCeram® Z-Al-Med-HD Colour, StarCeram® Z-Al-Med HD Translucent, and StarCeram® Z-Med TransColour, the primary difference from the predicate is the exact combination of qualities of zirconium dioxide used. All other physical properties are identical to the StarCeram® products cleared in K081263. | (No specific performance data is provided for these material variations, relying on biocompatibility and substantial equivalence.) |
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 applicable as the submission does not describe a clinical study measuring device performance in the context of diagnostic accuracy or similar metrics. The "Performance Data" section explicitly states, "No performance data was required or provided." The evaluation focused on biocompatibility and substantial equivalence.
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 applicable. No test set or ground truth in the context of a diagnostic or therapeutic AI/ML device is mentioned. The assessment revolved around material properties and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
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. The device is a dental blank, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The "ground truth" in this context would be the successful demonstration of biocompatibility per ISO standards and the physical properties aligning with predicate devices, rather than a clinical ground truth for a diagnostic task.
8. The sample size for the training set
This information is not applicable. No AI/ML model training is described.
9. How the ground truth for the training set was established
This information is not applicable.
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(119 days)
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."
| Acceptance Criteria (from ISO 6872:2008) | Reported Device Performance (Zenolux) |
|---|---|
| Thresholds for Type II, class 5 dental ceramic | Exceeds thresholds by far (for mechanical strength) |
| Water solubility limits | Extremely low water solubility |
| Biocompatibility requirements | High biocompatibility |
| Flexural strength (for Type II, class 5 ceramic, suitable for three-unit prostheses involving molar restoration) | Even better compared to predicate devices; exceeds threshold by far. |
| Wear/abrasion characteristics (compared to conventional veneering porcelain) | Similar to predicate materials and lower than conventional veneering porcelain |
| Fit of 3-unit bridges | Excellent and identical to other clinically approved CAD/CAM materials (e.g., zirconia) |
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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