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A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

gebdi Tribos 501 artificial teeth devices are chemically based on polymethacrylate-polymers and their geod Thirddin tectif devices are enternitures are used when fabricating any kind of dental chemical properties. These provisional restaurations and/or removable dental prostheses at the dental laboratory only.

This document is a 510(k) summary for the gebdi Tribos 501, a preformed plastic denture tooth. It establishes substantial equivalence to a predicate device (K790439 - Vivadent (USA) Inc.) rather than demonstrating de novo performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and sample sizes for performance evaluation is not applicable to this type of submission.

Here's an analysis based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This 510(k) submission establishes substantial equivalence to a predicate device, K790439. It does not define specific performance acceptance criteria for the new device as would be seen in a clinical trial or performance study for a novel device. The core argument is that the gebdi Tribos 501 is "similar to the P.D. in terms of technical characteristics, design, Indications for Use, ... performance, biocompatibility characteristics as well as sizes and target population."

The summary states: "The presented data that was conducted on the gebdi products shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any questions regarding safety and effectiveness."

This statement implies a comparison was made, but not against pre-defined, quantitative acceptance criteria for performance; rather, it refers to a qualitative comparison demonstrating similarity in performance to the predicate.

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

Not Applicable. No "test set" in the context of a performance study (e.g., clinical trial with patient data) is mentioned. The submission is based on a comparison to a predicate device and existing market history.

• The document notes: "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no safety or functional failures." This suggests historical data or market surveillance in Europe, but no specific sample size from a controlled test set is provided.

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

Not Applicable. No independent expert review or ground truth establishment for a specific test set is described. The equivalency is asserted based on characteristics and previous market performance.

4. Adjudication method for the test set

Not Applicable. As no specific test set requiring adjudication is mentioned, no adjudication method is provided.

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 a passive, preformed dental product, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are irrelevant.

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

Not Applicable. As noted above, this is a physical dental device, not an algorithm.

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

Not Applicable. Ground truth in the context of a validation study (e.g., for diagnostic accuracy) is not relevant to this 510(k) submission. The safety and effectiveness are established through substantial equivalence to a legally marketed predicate device, backed by historical market performance in Europe.

8. The sample size for the training set

Not Applicable. This is a physical device, and therefore the concept of a "training set" (as used in machine learning or AI context) does not apply.

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

Not Applicable. As no training set is relevant, no ground truth establishment for it is described.

In summary, the provided text describes a 510(k) premarket notification for a dental device (gebdi Tribos 501 preformed plastic denture tooth). The submission relies on demonstrating substantial equivalence to a predicate device (Vivadent (USA) Inc. K790439) in terms of materials, design, indications for use, performance, and biocompatibility. It also mentions that the product has been on the European market for many years "with no safety or functional failures," further supporting its safety and effectiveness. This type of submission generally does not involve the detailed performance studies, acceptance criteria, or ground truth establishment that would be seen for novel devices requiring clinical validation or AI algorithm performance assessment.

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