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510(k) Data Aggregation
(119 days)
ZENOLUX
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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