(102 days)
This device is intended to manufacture dental prosthesis as artificial crown, bridge and dental core
The device is intended to manufacture crown and bridge porcelainfused-to-metal prostheses and dental cores
Dental Porcelain (Glass Powder) Top-Ceram Powder T-1, T1, T2, T3, T4 are composed of Lanthanum oxide (La2O3), Cerium oxide (CeO2), Titanium xide( TiO2), Silicon dioxide (SiO2), Calcium oxide(CaO), Aluminum oxide(Al2O3), Iron oxide(Fe2O3) and they are intended for use by dental technicians for dental prothesis.
This document describes a 510(k) premarket notification for "Dental Porcelain (Glass Powder) Top-Ceram Powder T-1, T1, T2, T3, T4" by Global Top Inc. The submission aims to establish substantial equivalence to a predicate device, K062504 CeraMax marketed by Alphadent Co., Ltd.
The provided text focuses on the administrative aspects of the 510(k) submission, including device description, intended use, and comparison to a predicate device. It explicitly states that the device is equivalent to the predicate device in "*components, *indications for use, *chemical properties, and *performance properties."
However, the provided text does not contain any information regarding specific acceptance criteria, study design, or performance metrics. It does not present a table of acceptance criteria and reported device performance. Therefore, I cannot answer the majority of your questions about the study that proves the device meets acceptance criteria.
Here's what information I can extract based on the provided text, and what I cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document states that the device is equivalent to the predicate in "performance properties" but does not define these properties, set acceptance criteria, or report any performance data for the Top-Ceram Powder.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot provide. No information on a test set, sample size, or data provenance is presented.
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)
- Cannot provide. No mention of experts or ground truth establishment for a test set. This device is a material (dental porcelain), not a diagnostic device that would typically involve expert ground truth for performance evaluation in the way you're asking.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot provide. Not applicable, as there's no test set or adjudication process described.
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
- Cannot provide. This device is a dental material, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant to its evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Cannot provide. Not applicable, as this is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot provide. No information on ground truth is provided. For a dental material, "ground truth" would typically relate to material properties (e.g., strength, hardness, biocompatibility), which would be assessed through laboratory testing, not expert consensus in the diagnostic sense.
8. The sample size for the training set
- Cannot provide. Not applicable as this is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Cannot provide. Not applicable.
What the document does indicate:
- Device Type: Dental Porcelain (Glass Powder)
- Intended Use: To manufacture dental prosthesis as artificial crown, bridge, and dental core.
- Comparison Basis: Substantial equivalence to predicate device K062504 CeraMax by Alphadent Co., Ltd.
- Equivalence Claims: Based on "components, indications for use, chemical properties, and performance properties." This suggests that the "study" for this type of device typically involves demonstrating similar material characteristics and intended application to a legally marketed predicate, rather than a clinical performance study with human readers or AI.
To obtain the information you are requesting about acceptance criteria and detailed study data, one would need to review the specific performance data and testing protocols that were submitted as part of the K081200 510(k) substantial equivalence determination, which are not included in this summary document. The summary only makes a general statement about equivalence in performance properties.
§ 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.