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Dental Lithium Disilicate Glass-Ceramic is available using CAD/CAM and hot pressing techniques for the preparation of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges.

Dental Lithium Disilicate Glass-Ceramic is a lithium disilicate ceramic to be supplied in the form of cuboid and cylinder. Dental Lithium Disilicate Glass-Ceramic can be fabricated using CAD/CAM and hot pressing technologies. The device is a glass type material used for aesthetic purposes of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges. The ceramics material is composed of SiO2, Li2O, K2O, Al2O3, P2O5, ZrO2 and other oxides. It contains inorganic pigments. The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.

This document is a 510(k) summary for a dental material, not an AI/ML medical device. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable.

The document describes the acceptance criteria for the Dental Lithium Disilicate Glass-Ceramic device and the non-clinical testing performed to demonstrate its compliance.

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

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

The document provides a comparison table (Table 1) that includes several parameters which act as acceptance criteria derived primarily from the ISO 6872:2015 standard for ceramic materials. The "New Device" column shows the reported device performance.

Study that proves the device meets the acceptance criteria:

The device's performance was proven through a series of bench tests and compliance with international standards. The Section "5. Non-clinical Testing Summary" states: "Bench tests were conducted to verify that the proposed device met all requirements. The test results demonstrated that the proposed device complies with the following standards:"

• ISO 6872 Fourth edition 2015-06-01, Dentistry - Ceramic materials: This standard directly specifies the physical and chemical properties (like flexural strength, chemical solubility, linear thermal expansion, radioactivity) that the "Dental Lithium Disilicate Glass-Ceramic" must meet for its classification (Type II, Class 3).
• ISO 7405 Third edition 2018-10 Corrected version 2018-12, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry,
• ISO 10993-3 Third edition 2014-10-1, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity,
• ISO 10993-5 Third edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity,
• ISO 10993-6 Third edition 2016-12-01, Biological evaluation of the medical devices - Part 6: Tests for Local Effects after Implantation,
• ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for skin sensitization,
• ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity,
• ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation.

These ISO 10993 series standards and ISO 7405 address the biocompatibility of the material.

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

This information is not provided in the document. For bench testing of materials, sample sizes are typically determined by the relevant ISO standards.

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 document is about a dental material, not an AI/ML diagnostic or image analysis device that requires expert-established ground truth. The "ground truth" for material properties is established through standardized laboratory measurements.

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

Not applicable for material bench 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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

For this device, the "ground truth" is defined by the physical, chemical, and biological properties as specified in the referenced ISO standards. For example, the "ground truth" for flexural strength is the value measured according to ISO 6872, and this measured value must meet or exceed the specified threshold ($\geq300MPa$). Similarly for chemical solubility, linear thermal expansion, and biocompatibility.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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