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Artegral HD are posterior preformed plastic denture teeth for use in:

• supra construction for combined, fixed removable dental prostheses .
• hybrid construction for implant-supported dental prostheses .
• cover denture .
• total prostheses .
• model cast prostheses ●
• . partial dentures

artegral HD are preformed posterior plastic teeth made from an Interpenetrated Network (IPN) of polymethylmethacrylate (PMMA) with two finer Networks. The tooth neck is made from Organic Modified Polymer Network (OMP-N) and the incisal and dentine portions of the tooth are made from Highly Modified Polymer-Network (HMP-N). OMP-N has added insoluble PMMA spheres, and HMP-N has added amorphous silicon dioxide nanoparticles and fluorapatite. The artegral HD teeth comply with all the requirement of ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses. The additives in artegral HD teeth are known biocompatible materials.

The provided document, K120404, pertains to the 510(k) premarket notification for the Merz Dental GmbH artegral HD preformed plastic denture teeth. This submission focuses on chemical and physical characteristic comparisons to a predicate device, rather than a diagnostic AI device requiring performance metrics like sensitivity or specificity. Therefore, many of the requested categories related to AI device performance evaluation are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• The document does not specify a "test set" in the context of diagnostic data. The testing involved samples of the artegral HD teeth and their material components.
• Data Provenance: The tests were conducted internally by Merz Dental GmbH (Germany). The specific labs or testing facilities are not detailed, but the document refers to compliance with international standards (ISO, USP, EC, OECD, EN/DIN), implying standard testing methodologies. All testing was prospective, as it was performed on the device components for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is not a diagnostic tool requiring expert interpretation of images or clinical data to establish ground truth. The "ground truth" here is compliance with established physical, chemical, and biological standards.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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 device is not an AI-assisted diagnostic tool.

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

• Not applicable. This device is not an algorithm. Performance testing was done on the physical product and its constituent materials.

7. The type of ground truth used:

• Standard-based compliance: The ground truth for this device is based on the requirements and limits defined in established international and national standards for artificial denture teeth and biocompatibility, such as:
  • ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses
  • ISO/CD 20795-1 "Dentistry - Base polymers - Part 1: Denture base polymers"
  • USP 29 (United States Pharmacopeia)
  • ISO 10993 Part 5 (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)
  • EC method B.6. (European Commission method)
  • OECD guideline 406 (OECD Guidelines for the Testing of Chemicals - Skin Sensitisation)
  • EN/ISO/DIN 10993-10.2 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)

8. The sample size for the training set:

• Not applicable. This device does not use machine learning, so there is no training set.

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

• Not applicable. See point 8.

In summary: The K120404 submission for Merz Dental GmbH artegral HD preformed plastic denture teeth is primarily a substantial equivalence claim based on demonstrating that the device meets the physical, chemical, and biological safety requirements of relevant international standards. It does not involve AI or diagnostic performance studies that would utilize concepts like ground truth established by experts, test sets, or training sets. The "proof" that the device meets acceptance criteria comes from the successful completion of the specified laboratory tests according to the cited standards.

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