(242 days)
Nacera Pearl blanks are indicated for the fabrication of single crowns and bridgework:
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fully anatomical single crowns and bridgework (FCZ)
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Partially veneered or fully veneered crowns and bridges
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Inlays, onlays, and Maryland bridges
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Primary telescopic crowns
for anterior and posterior applications
The devices covered by this submission are milling blanks for the fabrication of custom-made all-ceramic dental restoration. The devices are manufactured from yttria-stabilized tetragonal zirconia (Y-TZP) complying with all applicable requirements of ISO 6872 (dental ceramics) and all requirements of ISO 13356 (ceramic materials for implants for surgery). They are provided in a partially sintered (pre-sintered) state. They are intended to be used by dental professionals e.g. dental technicians, for the fabrication of custom-made restorations for the sole use of a particular patient. These restorations are designed virtually by dental technicians using the CAD technology on the basis of intraoral scans or scans from impressions and/or models. The designed restorations are to be machined in all appropriate CAM Milling Centers out of Nacera Pearl blanks and finally sintered to full density. On basis of the available shades the finished restorations, sintered to full density, may be used as full-contour, all-ceramic prosthesis or may be veneered with suitable dental porcelains using the layering technique. Telescopic primary crowns will not be veneered. Nacera Pearl blanks are available in various shapes and dimensions such as discs, cylinders, bars, cubes, or other required forms, in order to meet the specifications of the different CAD/CAM milling machines used to generate the desired dental restorations. Nacera Pearl blanks are available in various shades in order to correspond to the different natural teeth colors and have a closer appearance to a natural tooth.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Nacera Pearl device:
Important Note: The provided text is a 510(k) summary for a dental material (Nacera Pearl), not a medical device in the typical sense of AI algorithms or diagnostic tools. Therefore, many of the requested categories (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance of an algorithm) are not applicable to this type of submission. This document describes a material's physical and chemical properties in comparison to existing, legally marketed materials.
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for an AI algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it demonstrates substantial equivalence by comparing the physical and chemical properties of the Nacera Pearl material to legally marketed predicate devices. The "acceptance criteria" are implied to be that the properties of Nacera Pearl are "comparable" to those of the predicate devices, as assessed against established international standards.
Table 1: Acceptance Criteria (Implied) and Reported Device Performance (Comparative)
| Property | Acceptance Standard (Implied) | Nacera Pearl Performance (Relative to Predicates) |
|---|---|---|
| Material Composition | Porcelain powder Y-TZP (same as predicates) | Same |
| Further Processing | Milling in CAM milling centers using CAD/CAM tech | Same |
| Types | Pre-sintered blanks | Same |
| Physical Properties | ISO 13356 and ISO 6872 (dental ceramics) | Complies with these standards |
| Density | Comparable to predicates (ISO 13365) | Comparable |
| Microstructure | Comparable to predicates (ISO 13365) | Comparable |
| Flexural Strength | Comparable to predicates (ISO 13365) | Comparable |
| Radioactivity | Comparable to predicates (ISO 13365) | Comparable |
| Thermal Expansion | Comparable to predicates (ISO 13356) | Comparable |
| Chemical Solubility | Comparable to predicates (ISO 13356) | Comparable |
| Open Porosity | Comparable to predicates | Comparable |
| Tensile Strength | Comparable to predicates | Comparable |
| Elastic Limit | Comparable to predicates | Comparable |
| Bending Strength | Comparable to predicates | Comparable |
| Young's Modulus | Comparable to predicates | Comparable |
The "study" that proves the device meets these criteria is the Performance Testing conducted by the submitter.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify exact sample sizes for the material testing. Terms like "a series of testing" are used, implying multiple measurements were taken for each property to ensure reproducibility and reliability, but specific n values are not provided.
- Data Provenance: Not explicitly stated. Given the submitter (Doceram Medical Ceramics GmbH) is based in Germany, it is highly likely the testing was performed in Germany or an affiliated European laboratory. The tests are against international standards (ISO), which implies a standardized, global approach to testing, but the country of origin of the data generation itself is not detailed. The data would be considered prospective in the sense that the material was manufactured for the purpose of this testing.
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. This is a material science characterization, not an expert-based diagnostic assessment. The "ground truth" is established by physical and chemical measurements using calibrated laboratory equipment and standardized testing protocols (ISO 13365, ISO 13356). There are no human experts involved in subjectively establishing "ground truth" as would be the case for medical image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no adjudication method as this is not an interpretive diagnostic study. The results are quantitative measurements against predefined physical and chemical 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
- Not Applicable. This is a material testing conformity assessment, not an MRMC or AI-assisted diagnostic study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- 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 submission are the physical, chemical, and mechanical properties determined through standardized laboratory testing (e.g., density, flexural strength, thermal expansion, chemical solubility) as defined by ISO 13356 and ISO 6872. These are objective, measurable properties.
8. The sample size for the training set
- Not Applicable. This is a physical product (dental material), not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.