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The Valplast International Corporation Yamahachi Teeth are prefabricated, preformed plastic teeth that are intended for use as teeth in removable dentures.

The Yamahachi Teeth are anterior and posterior teeth that are intended to be used in removable dentures only. They are made up of three synthetic polymers including polymethlymethacrylate, polymethylmethacrylate-SiO2, and a composite resin urethane dimethacrylate-polymethylmethacrylate - SiO2. The Yamahachi Teeth are used in conjunction with a denture-base resin for construction of removable full and partial dentures. The teeth are intended to be used by dental professionals such as dentists and dental technicians. The Yamahachi line of teeth include various sizes, shapes, and shades of anterior and posterior preformed plastic teeth

The Yamahachi Teeth did not undergo studies with acceptance criteria regarding diagnostic performance or human-AI reader comparisons, as it is a physical medical device (preformed plastic teeth for dentures), not an AI/software device. The provided text details the device's physical characteristics, intended use, and compliance with various international standards for dental materials.

Here's an analysis of the provided information, focusing on criteria relevant to physical medical devices, and noting where typical AI/software study criteria do not apply:

Acceptance Criteria and Reported Device Performance

Study Information (as relevant for a physical medical device)

The information provided describes compliance with international standards for dental materials rather than a clinical study with a detailed test set, ground truth experts, or statistical performance metrics typically associated with AI/software devices.

1. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/software device. For a physical product like denture teeth, "testing" refers to laboratory evaluations of material properties. The document does not specify sample sizes for these laboratory tests (e.g., how many teeth were tested for strength or color stability). The provenance is implied to be from the manufacturer's testing in the context of achieving ISO standard compliance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's material properties is established through adherence to standardized testing protocols (e.g., ISO standards), not expert consensus on diagnostic images.
3. Adjudication method for the test set: Not applicable. Material property tests follow established protocols; there is no "adjudication" in the sense of reconciling expert opinions.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating diagnostic performance of imaging devices or AI algorithms with human readers. The Yamahachi Teeth are a physical product.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This concept is for AI algorithms.
6. The type of ground truth used: For this physical device, "ground truth" refers to the established specifications and performance metrics outlined in the referenced international standards (e.g., EN ISO 3336:1997). The device's performance is measured against these objective, standardized criteria.
7. The sample size for the training set: Not applicable. The device is a physical product and does not involve AI model training.
8. How the ground truth for the training set was established: Not applicable.

Summary of "Study" Description:

The provided text details that "Extensive testing has been performed on the Yamahachi Teeth to demonstrate compliance" with several EN ISO standards. These standards (e.g., EN ISO 3336, EN ISO 7405, EN ISO 1567, EN ISO 3950, EN ISO 7491) define the requirements and test methods for synthetic polymer teeth, biocompatibility, denture base polymers, dental designation systems, and color stability of dental polymeric materials, respectively.

The submission asserts that the device is "substantially equivalent" to predicate devices based on its material composition and intended use, and its compliance with these recognized international standards for performance and safety. This compliance is the "proof" that the device meets the acceptance criteria for a physical medical device of this type. The 510(k) clearance by the FDA (K060507) confirms this substantial equivalence determination based on the provided testing and documentation.

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