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LUXEN 5G is ceramic block used to create customized dental restorations using CAD/CAM system. LUXEN 5G block are available in three shapes (Block, Wieland, D95) and various thickness sizes. LUXEN 5G is composed of yttria-stabilized zirconia and 3~4 mol % TZP. The weight of yttria is classified in accordance with ISO 6872:2015 Type2, class 5 for 3Y-TZP Zirconia.

AI/ML Overview

The provided text is a 510(k) summary for the LUXEN 5G dental ceramic block, seeking substantial equivalence to the predicate device LUXEN ZR. It details the device's characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria (Predicate/Standard)	Reported Device Performance (LUXEN 5G)
Classification (ISO 6872:2015)	Type II Class 5	Type II Class 5
Flexural Strength	>800 Mpa (ISO 6872:2016 Class 5)	>800 Mpa
Thermal Expansion Coefficient (20-500°C)	10.7 X 10⁻⁶ K⁻¹ (Predicate LUXEN ZR)	11.0 X 10⁻⁶ K⁻¹
Chemical Solubility		Performed and assumed to meet standards

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each specific test (e.g., how many blocks were tested for flexural strength). It broadly states that "performance tests" and "biocompatibility tests" were conducted. The manufacturer is Dentalmax Co., Ltd. from Cheonan-Si, Chungnam, South Korea, suggesting the testing was performed, or at least sponsored, in South Korea. The study is a non-clinical performance study rather than a clinical study with patients, so the terms "retrospective" or "prospective" are not directly applicable in the same way.

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 type of information is not applicable as the document describes a non-clinical performance study of a dental material, not an AI or diagnostic device that requires expert ground truth for interpretation. The ground truth for performance characteristics is established by objective physical and chemical testing against international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as #3. Adjudication methods are typically used in clinical studies or studies involving expert interpretation, not in objective material property 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 information is not applicable. The device is a dental ceramic block, not an AI or diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a dental ceramic block, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance characteristics of the LUXEN 5G device is based on objective measurement against established international standards, specifically ISO 6872:2015 and ISO 10993 for biocompatibility, and USP for pyrogenicity. The predicate device's performance also serves as a comparative ground truth.

8. The sample size for the training set

This information is not applicable. The device is a dental material, not an AI system that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as #8.

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