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510(k) Data Aggregation
(518 days)
LUXEN Zr, LUXEN Smile
LUXEN Zr is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks. LUXEN Smile is indicated for the production of full ceramic crowns, onlays, 3bridges and inlay bridges (anterior and molar).
LUXEN Zr and LUXEN Smile are used for custom made dental restorations using a CAD/CAM system. The LUXEN Zr and LUXEN Smile are provided in 4 different shapes - block, disk, Wieland and D-95. The LUXEN Zr is composed of 3 mol% TZP. LUXEN Smile is composed of 5 mol% TZP. The weight of yttria is classified in accordance with ISO 6872:2015 Type2, class 5 for 3Y-TZP Zirconia, and ISO 6872:2015 Type2, class 4b for 5Y-TZP Zirconia, respectively.
The provided text describes the non-clinical performance testing of two dental devices, LUXEN Zr and LUXEN Smile, to demonstrate their substantial equivalence to predicate devices. However, the document does not contain information about an AI/ML device. Therefore, I cannot fulfill the request for information on acceptance criteria, a study proving device meeting acceptance criteria, sample sizes, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, or training set details as these are specific to AI/ML device evaluations.
The document focuses on the physical properties and biocompatibility of dental materials.
Here's a breakdown of what the document does provide regarding the non-clinical performance and acceptance criteria for these dental materials:
1. A table of acceptance criteria and the reported device performance
The document provides comparative tables for LUXEN Zr vs. DD Bio ZX2 and LUXEN Smile vs. DD cube X2. These tables list various characteristics (such as flexural strength, chemical composition, thermal expansion coefficient, chemical solubility, etc.) and compare the subject device's performance against the predicate device or a relevant ISO standard. The acceptance criteria are implicitly defined by meeting or being similar to the predicate device's performance or exceeding minimum ISO standards.
LUXEN Zr (for 3Y-TZP Zirconia, ISO 6872:2015 Type2, Class 5)
| Characteristic | Acceptance Criteria (Predicate/Standard) | Reported Device Performance (LUXEN Zr) | Outcome |
|---|---|---|---|
| Classification Name | Porcelain powder for clinical use | Porcelain powder for clinical use | Similar |
| Product Code | EIH | EIH | Similar |
| Device Class | II | II | Similar |
| Blank configuration | Block, Disk, Wieland, D-95 type | Block, Disk, Wieland, D-95 type | Similar |
| Thicknesses | 10 mm to 25 mm | 10 mm to 25 mm | Similar |
| Crystal Morphology | 3Y-TZP | 3Y-TZP | Similar |
| Color | VITA shade guide met | VITA shade guide met | Similar |
| Sintering temperature | 1450 °C (predicate) | LUXEN Zr ST: 1580 °C, Others: 1500 °C | Similar (optimized for translucency) |
| Types, Class (ISO6872:2015) | Type II Class 5 | Type II Class 5 | Similar |
| Chemical composition (wt.%) | Meet ISO 13356 (e.g., Al2O3 ≤ 0.5%) | Meets ISO 13356 | Similar |
| Flexural strength (MPa) | 1250 (predicate) / >800 MPa (ISO) | 1038 ± 135 | Similar (higher than ISO) |
| Thermal expansion coeff. | 10 X 10-6 K-1 | 10.7 X 10-6 K-1 | Similar |
| **Chemical solubility (µg/cm²) ** | Not listed (predicate) | 0 | - |
| Biocompatibility | ISO 10993 and ISO 7405 | Biocompatible per ISO 10993-1 | Similar |
| Sterile | Non-sterile | Non-sterile | Similar |
LUXEN Smile (for 5Y-TZP Zirconia, ISO 6872:2015 Type2, Class 4b)
| Characteristic | Acceptance Criteria (Predicate/Standard) | Reported Device Performance (LUXEN Smile) | Outcome |
|---|---|---|---|
| Classification Name | Porcelain powder for clinical use | Porcelain powder for clinical use | Similar |
| Product Code | EIH | EIH | Similar |
| Device Class | II | II | Similar |
| Blank configuration | Disk, Wieland type | Block, Disk, Wieland, D-95 type | Similar |
| Thicknesses | 10 mm to 25 mm | 10 mm to 25 mm | Similar |
| Crystal Morphology | 5Y-TZP | 5Y-TZP | Similar |
| Color | VITA shade guide met | VITA shade guide met | Similar |
| Sintering temperature | 1450 °C | 1450 °C | Similar |
| Types, Class (ISO6872:2015) | Type II Class 4 (predicate, ISO 6872:2008) | Type II Class 4b (ISO 6872:2015) | Similar |
| Chemical composition | Meet ISO 13356 (e.g., Al2O3 ≤ 0.5%) | Meets ISO 13356 | Similar |
| Flexural strength | > 750-800 MPa (predicate) / >500 MPa (ISO) | 770 ± 66 MPa | Similar (higher than ISO) |
| Thermal expansion coeff. | 10 X 10-6 K-1 | 10.3 X 10-6 K-1 | Similar |
| Chemical solubility | 15 μg/cm² (predicate) / >2000 μg/cm² (ISO) | 0 μg/cm² | Similar (better than predicate and ISO) |
| Biocompatibility | EN ISO 10993-1, -5 | Biocompatible per ISO 10993-1 | Similar |
| Sterile | Non-sterile | Non-sterile | Similar |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for each non-clinical test (e.g., number of specimens for flexural strength, chemical solubility). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.
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)
This is not applicable as the study involves physical and biocompatibility testing of dental materials, not an AI/ML device requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for non-clinical material testing.
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 is not applicable. This document is not about an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This document is not about an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is established by the measurement outcomes of validated physical and chemical tests, and comparison against international standards (e.g., ISO 6872:2015, ISO 13356) and the characteristics of predicate devices. Biocompatibility uses established ISO 10993 series standards as the "ground truth" for safe biological interaction.
8. The sample size for the training set
This is not applicable as the document describes non-clinical testing of a dental material, not an AI/ML algorithm.
9. How the ground truth for the training set was established
This is not applicable as the document describes non-clinical testing of a dental material, not an AI/ML algorithm.
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