(169 days)
Estar-Z is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.
Estar-Z is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.
Estar-Z is prefabricated ceramic block (pre-sintered yttrium-stabilized zirconium oxide) which is to be milled and sintered in the furnace to produce the final dental restorations. After sintering, it forms polycrytstalline oxide ceramic consisted of Tetragonal Zirconium Oxide Polycrystal (TZP).
Estar-Z is provided in three types as Estar-Z T, Estar-Z HT, and Estar-Z ST. In accordance with ISO 6872:2015, Estar-Z T and Estar-Z HT are classified as Type II Class 5 zirconia and Estar-Z ST is classified as Type II Class 4b zirconia.
Estar-Z is provided in non-sterile and available in various shades and thickness of disk shape (Ø98mm).
The provided document is a 510(k) Summary for the dental ceramic device Estar-Z. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. As such, it does not contain information about a study proving the device meets specific acceptance criteria using a human-in-the-loop or standalone AI performance evaluation. This document details the physical properties and biocompatibility of the ceramic material itself.
Therefore, many of the requested elements for an AI device study (e.g., sample sizes of test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.
However, I can extract the acceptance criteria and reported device performance for the physical properties of the ceramic material, as this is the focus of the substantial equivalence claim.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by the ISO 6872:2015 standard for dentistry ceramic materials. The reported device performance is compared against these standards and the predicate devices.
| Property | Standard/Acceptance Criteria (ISO 6872:2015) | Estar-Z T & HT (reported) | Estar-Z ST (reported) | Predicate Device LUXEN Zr (K171585 - reported) | Predicate Device LUXEN Smile (K171585 - reported) |
|---|---|---|---|---|---|
| Classification | Type II Class 5 (for Estar-Z T & HT) | Met | N/A | Type II Class 5 | N/A |
| Flexural Strength | >800 MPa (for Type II Class 5) | >800 MPa | N/A | 1038 ± 135 MPa (for Type II Class 5) | N/A |
| Classification | Type II Class 4b (for Estar-Z ST) | N/A | Met | N/A | Type II Class 4b |
| Flexural Strength | >500 MPa (for Type II Class 4b) | N/A | >500 MPa | N/A | 770 ± 66 MPa (for Type II Class 4b) |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The document refers to non-clinical testing with "evaluation criteria" from ISO standards but does not specify sample sizes for these tests. Data provenance (country of origin, retrospective/prospective) is not applicable to material properties testing described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in this context refers to physical material properties measured according to established ISO standards, not expert interpretations of medical images or clinical data.
4. Adjudication method for the test set
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
Not applicable, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI device.
7. The type of ground truth used
The ground truth used for performance evaluation of Estar-Z's physical properties are the specifications and requirements set forth by international standards, specifically ISO 6872:2015 for Dentistry Ceramic Materials and ISO 13356:2015 for Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
For biocompatibility, the ground truth is established by adherence to ISO 10993 series and ISO 7405 standards.
8. The sample size for the training set
Not applicable, as this is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.