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LUXEN 5G is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks.

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.

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

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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LUXEN CL Dental Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.

The subject device is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth. The liquid has 100 shades are available in 10ml, 30ml, 50ml, 50ml and 100ml volumes. Luxen CL-Diluent and Luxen CL-Pontic Liquid are used to dilute the color of other products. Luxen CL-Pontic and Luxen-CL Diluent is used to dilute Base liquid and special color liquid.

This document describes the premarket notification (510(k)) for LUXEN CL Dental Liquid. The information provided heavily focuses on establishing substantial equivalence to a predicate device rather than detailing extensive performance studies with specific acceptance criteria and detailed quantitative results for the device itself.

Based on the provided text, here's an attempt to answer your questions, highlighting where information is not present:

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

The document does not provide a table of acceptance criteria with specific quantitative performance metrics for the LUXEN CL Dental Liquid for color outcomes. Instead, it relies on demonstrating substantial equivalence through biocompatibility testing and general performance observation.

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

• Sample Size: Not specified for any of the performance tests. The document only lists the types of tests performed.
• Data Provenance: Not specified. It's presumably from DENTALMAX Co., Ltd. (Republic of Korea, as per registrant address), but whether internal or external lab, retrospective or prospective generation, is not stated.

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)

Not applicable. This device is a dental coloring liquid, not an AI or diagnostic medical device requiring expert interpretation for ground truth. The performance tests are focused on physical and biocompatibility properties.

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

Not applicable. This is not a study requiring adjudication for subjective interpretations.

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. This is not an AI-assisted diagnostic or imaging device.

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

Not applicable.

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

For the non-clinical tests (biocompatibility, physical properties, shelf life), the "ground truth" would be established by the adherence to the referenced ISO standards (e.g., ISO 10993-5 for cytotoxicity) and internal quality control specifications for physical attributes. There is no mention of external "ground truth" of the type relevant to diagnostic performance (e.g., pathology reports for disease detection).

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a training set is used.

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

Not applicable.

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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)

LUXEN Smile (for 5Y-TZP Zirconia, ISO 6872:2015 Type2, Class 4b)

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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