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NobelRondo Dental Ceramic - Zirconia is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from zirconia.
NobelRondo Dental Ceramic – Zirconia is dental porcelain intended for use in the construction of zirconium oxide ceramic prosthetics. NobelRondo consists of sixteen (16) porcelain shades corresponding to Vita shades A0-C3 and various shade modifiers. The shade modifiers are intended to give the user flexibility in creating a translucent or opalescent natural looking prosthetic. NobelRondo also includes mixing liquids and shade guides. The various porcelains and modifiers are used in a build-up process. After applying each layer, the restoration is fired following directions in the Instructions for Use. All of the component porcelains and modifiers can be used in combination without restriction. The dental technician will use the components as needed to create the desired prosthetic. However, typical use includes using a base liner followed by a build-up material and finally glazes and stains. Throughout this process, modifiers for translucent and opalescent effects can be added. The NobelRondo Dental Ceramic – Zirconia is sold in kit form. The various porcelains and modifiers are packaged in polyethylene bottles with screw caps. Replacement bottles for each porcelain or modifier are available individually.
The provided text describes a 510(k) submission for a dental ceramic product, NobelRondo Dental Ceramic – Zirconia. It outlines the device description, indications for use, and a list of performance standards to which it conforms. However, it does not contain information about a specific study designed to prove the device meets acceptance criteria, nor does it provide detailed device performance metrics in the way typically expected for clinical or performance studies.
The document primarily focuses on regulatory compliance through adherence to recognized consensus standards for dental ceramics and biocompatibility.
Therefore, many of the requested items cannot be extracted from this text.
Here's an attempt to populate the table and answer the questions based only on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Conformity to Standards | ISO 6872:1995 – Dental Ceramic | Device "conforms with" ISO 6872:1995 |
| ISO 7405:1997 – Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry – Test Methods for Dental Materials | Device "conforms with" ISO 7405:1997 | |
| ISO 9693:1999 – Metal-ceramic Dental Restorative Systems | Device "conforms with" ISO 9693:1999 | |
| Regulatory Status | Substantially Equivalent to Predicate Device | FDA reviewer determined the device is "substantially equivalent" to a legally marketed predicate (K041312) |
Note: The text explicitly states "NobelRondo Dental Ceramic – Zirconia conforms with the following standards". It does not report specific numerical performance data against these standards, but rather claims conformity.
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 provided in the document. The text refers to conformity with standards but does not detail any specific test sets or studies that were conducted to demonstrate this conformity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 provided in the document. The device is a dental ceramic, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a dental ceramic, so this type of study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. The "ground truth" here is implied to be adherence to the specifications and performance requirements outlined in the cited ISO standards, likely demonstrated through material testing, but the details of such testing are not included.
8. The sample size for the training set
This information is not provided in the document. The device is a physical material, not a machine learning model, so the concept of a "training set" is not applicable in this context.
9. How the ground truth for the training set was established
This information is not provided in the document (and is not applicable for this type of device).
§ 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.