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510(k) Data Aggregation
(89 days)
Estar-ZE
Estar-ZE is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.
Estar-ZE is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.
Estar-ZE 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). In accordance with ISO 6872:2015, it is classified as Type II Class 5 zirconia.
Estar-ZE is provided in non-sterile and available in various shades and thickness of disk shape and block shape
Here's a breakdown of the acceptance criteria and study information for the Estar-ZE device, based on the provided FDA 510(k) summary:
Device: Estar-ZE (Porcelain Powder for Clinical Use)
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Material Type | ISO 6872:2015 Classification | Type II Class 5 zirconia |
| Flexural Strength | >800 MPa | >800 MPa |
| Biocompatibility | ISO 10993 standards | Meets requirements |
Study Proving Device Meets Acceptance Criteria:
The provided document describes non-clinical performance testing to demonstrate substantial equivalence of the Estar-ZE device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for the mechanical properties or biocompatibility testing. It only states that the device was "designed and tested" and that "all tests have passed the evaluation criteria."
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin specified for the test data itself (although the manufacturer is based in Korea).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is a ceramic material and the testing described is non-clinical (mechanical properties, biocompatibility), not involving human diagnostic interpretation or ground truth established by experts.
4. Adjudication Method
This information is not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed. This type of study is typically relevant for AI/software devices where human readers provide diagnoses or interpretations.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not performed. This is also relevant for AI/software devices. The Estar-ZE is a physical dental material.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on established international standards:
- ISO 6872:2015 Dentistry - Ceramic Materials for mechanical properties (e.g., flexural strength, classification).
- ISO 10993 suite of standards for biocompatibility.
8. Sample Size for the Training Set
This information is not applicable. The Estar-ZE is a physical ceramic material, not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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(169 days)
Estar-Z
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.
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