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YAMAHACHI PMMA DISKS are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered.

Yamahachi PMMA Disks are acrylic blanks used in dental CAD/CAM milling systems by professional dental technicians to fabricate temporary crowns and bridges. After polishing, the prosthesis is adjusted in the patient's mouth and cemented or bonded in place, where it remains until removal when the permanent restoration is available.

The restoration process begins in the dental office with an intraoral scan of the affected tooth and the surrounding teeth. Proprietary software takes this digital image and creates a replacement part for the missing areas of the tooth, creating a virtual restoration. The software sends this virtual data to a milling machine where the replacement part is carved out of a Yamahachi PMMA Disk. The optical impression system, software, and milling machine are not part of the device.

The device is composed of hot-cured polymethyl methacrylate (PMMA) and pigments.

Yamahachi PMMA Disks are available in different shapes and shades, with disks of all shades available in different dimensions (diameter, thickness and profile margin). It is intended for use in both open and closed CAD/CAM systems. The circular disk model fits open milling systems, while the configurations for closed systems include Amann Girrbach, Zirkonzahn, block, pin and 2-pin.

The provided document is a 510(k) summary for the Yamahachi PMMA Disks, a dental device. It outlines the device's classification, intended use, and a comparison with a predicate device to establish substantial equivalence. The document includes information on non-clinical performance testing.

Here's a breakdown of acceptance criteria and the study as requested:

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

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

The document does not specify the sample size used for the non-clinical performance testing. It also does not provide information on the country of origin of the data or whether the study was retrospective or prospective. The testing is described as "Non-clinical Performance 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)

This section is not applicable as the study is a non-clinical performance test for a material (PMMA Disks), not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" here is the adherence to material standards (ISO 10477:2004).

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

This section is not applicable for the same reason as point 3. Material property testing relies on objective measurements against a standard, not on expert adjudication.

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

This section is not applicable. The device is a dental material (PMMA Disks), not an AI-driven or diagnostic device that would involve human readers or an MRMC study.

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

This section is not applicable. The device is a dental material, not an algorithm.

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

The ground truth for the non-clinical performance testing was based on international material standards, specifically ISO 10477:2004 for "Dentistry -- Polymer-based restorative materials." Compliance with this standard served as the ground truth for acceptability.

8. The sample size for the training set

This section is not applicable. The device is a material, not a machine learning model, so there is no "training set."

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

This section is not applicable for the same reason as point 8.

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