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Tetric® CAD is intended for:

• Veneers
• Inalys
• Onlays (e.g. occlusal veneers, partial crowns)
• Crowns in the anterior and posterior region

Tetric® CAD is a composite block for the fabrication of esthetic permanent inlays, onlays, veneers and crowns in the anterior and posterior region. Fabrication of the dental restoration is performed at the dentist's office in a compatible milling machine. The blocks are composed of cross-linked dimethacrylate and inorganic fillers. In the processing technique, the restoration is polished and seated after milling in the CAD/CAM system. The blocks are attached to a metal mandrel, the geometry of such is compatible with a milling machine, e.g. Cerec/InLab (Sirona), PlanMill (PlanMeca) or Programill One (Ivoclar Vivadent).

Tetric® CAD composite blocks are available in the translucency levels MT (5 shades - A1, A2, A3, A3.5, BL) and HT (4 shades 0 A1, A2, A3, A3.5), and in the sizes I12 and C14.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tetric® CAD device:

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for the new device's performance against specific clinical benchmarks. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical efficacy is not directly available in this type of submission. Instead, the focus is on showing similarity in functional performance and safety compared to an already approved device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence claim, the "acceptance criteria" are implicitly that the new device (Tetric® CAD) performs comparably or better than the predicate device (Cerasmart K133824) for the listed physical properties. The data presented are for comparison.

Note on Acceptance Criteria: For a 510(k), "acceptance criteria" mainly revolve around demonstrating the new device is as safe and effective as the predicate. For physical properties, this usually means meeting or exceeding the predicate's performance when tested under relevant standards. The document explicitly states "the results of the bench testing show the products to be substantially equivalent," meaning the Tetric® CAD met the implicit acceptance criterion of being comparable.

The subsequent points (2-9) are largely not applicable or not explicitly detailed in the provided 510(k) summary because this document focuses on bench testing and biocompatibility for material properties and substantial equivalence, rather than clinical efficacy studies with human subjects.

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 for test set: Not explicitly stated for specific tests like flexural strength or water solubility in the summary. For ISO standard compliance (like ISO 10477 and ISO 6872), specific sample sizes are prescribed by the standards, but these aren't given in this summary.
• Data provenance: Not specified in the summary. This would typically be from the manufacturer's R&D labs.
• Retrospective or prospective: Not applicable for bench (non-clinical) testing.

The following points (3-6) are typically relevant for clinical studies, which are not detailed in this 510(k) summary for Tetric® CAD, as the focus is on material properties and substantial equivalence through bench testing.

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 pertains to clinical studies often involving expert review of images or patient outcomes. The provided document details bench testing of material properties and biocompatibility, which does not involve establishing ground truth by human experts in this manner.

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

• Not Applicable. This is for clinical studies with human assessors.

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 type of study is typically for diagnostic AI devices, not for dental restorative materials like Tetric® CAD.

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

• Not Applicable. This refers to AI algorithm performance.

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

• For Flexural Strength and Water Solubility: The "ground truth" is established by the standardized measurement methods defined in ISO 6872:2015 and ISO 10477:2004, respectively.
• For Biocompatibility: The "ground truth" is determined by the results of specific in-vitro tests for cytotoxicity (EN ISO 7405:2008 + A1:2013; ISO 10993-5:2009) and genotoxicity (ISO 10993-3:2014), following the principles of ISO 10993-1:2009 + AC:2010.

8. The sample size for the training set

• Not Applicable. This is relevant for AI models. The document describes a material and its testing, not an AI system.

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

• Not Applicable. This is relevant for AI models.

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