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Yamahachi Pink CAD/CAM Disk is used for the fabrication of dentures.

PMMA Disks are polymethyl methacrylate blanks used to mill dentures in various CAD/CAM systems.

Yamahachi PMMA Disks are acrylic blanks used in dental CAD/CAM milling systems by professional dental technicians to fabricate dentures. 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 included in this submission.

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

Yamahachi Pink 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, closed and block type CAD/CAM systems. The circular disk model fits open milling systems, while the configurations for closed systems include Amann Girrbach, Zirkonzahn and block type can be used for any milling machine with the appropriate and compatible CAM system.

This document is a 510(k) premarket notification for a dental device, the Yamahachi Pink CAD/CAM Disk. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria derived from a study that quantifies specific performance metrics in a clinical context (e.g., accuracy, sensitivity, specificity for a diagnostic device).

Therefore, I cannot provide a direct answer to all parts of your request as it pertains to a medical device software approval process involving performance metrics, expert reads, and clinical study data. This document describes a material (PMMA disk) used for fabricating dentures, and its approval relies heavily on demonstrating equivalent physical and chemical properties and intended use to existing, approved materials.

However, I can extract the relevant information and explain why other sections of your request are not applicable for this type of device submission based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

Device: Yamahachi Pink CAD/CAM Disk
Regulation Number: 21 CFR 872.3760
Regulation Name: Denture relining, repairing, or rebasing resin
Product Code: EBI
Regulatory Class: Class II

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

For a material like this, the "acceptance criteria" are typically the standards conformance and physical/chemical property equivalence to a predicate, not performance metrics like sensitivity or specificity.

Note on "Acceptance Criteria" for this device: The primary "acceptance criteria" for a 510(k) submission like this are demonstrating:

• Same intended use as a predicate.
• Same technological characteristics (or differences that do not raise new questions of safety or effectiveness).
• Conformance to relevant performance standards (ISO standards in this case).

Regarding the "Study that proves the device meets the acceptance criteria":

The "study" here is non-clinical performance testing and comparison to predicates. It's not a clinical trial in the sense of a diagnostic AI device.

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

• Sample Size: Not specified in the document for the material testing. ISO standards often specify minimum sample sizes for various tests, but the report only states "The subject and predicate have both completed ISO standardized testing and have passed."
• Data Provenance: The material is manufactured by Yamahachi Dental Mfg., Co. in Japan. The testing was non-clinical (laboratory-based) and conducted to ISO standards.

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

• Not Applicable. This is not a diagnostic device where "ground truth" is established by expert readers. The "ground truth" for a material like this is defined by adherence to validated ISO standards for physical and chemical properties.

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

• Not Applicable. No human adjudication of results in the context of clinical reads is relevant for this material.

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 is not a diagnostic AI device subject to MRMC studies.

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

• Not Applicable. This is not a medical device algorithm.

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

• The "ground truth" is adherence to international consensus standards (ISO 10477:2004, ISO 20795-1:2013) for dental polymeric materials, combined with biocompatibility data from a previously cleared device (K131036) with identical chemical composition.

8. The sample size for the training set

• Not Applicable. This device is a material, not an AI/ML algorithm requiring a training set.

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

• Not Applicable. See point 8.

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PuRE PMMA Discs 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. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.

PuRE PMMA Discs 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. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology. The discs are provided non-sterile, without any accessories, and are indicated for single-use only.

The device is composed of polymethyl methacrylate and pigments. PuRE PMMA discs are available in 23 shades and varying thicknesses (14-30 mm).

This is a 510(k) summary for a dental device, specifically PMMA discs used for temporary crowns and bridges. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for an AI/ML device.

Therefore, many of the requested categories (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, training set) are not applicable or cannot be extracted from this document, as this type of submission generally relies on material properties testing and comparison to an already cleared predicate.

However, I can extract information related to the acceptance criteria for physical properties and details about the device's composition and manufacturing.

Here's a breakdown of the requested information based on the provided text:

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

Study that proves the device meets the acceptance criteria:
The document states that "Standardized performance and biocompatibility assessments, as well as differences between the devices, did not raise any new concerns regarding safety and effectiveness." and "The conclusions drawn from the non-clinical performance tests demonstrate that the PuRE PMMA Disc is substantially equivalent to the referenced predicate device."

This implies a series of non-clinical, in-vitro tests were conducted according to the specified ISO and JIS standards to evaluate the physical properties of the PuRE PMMA Disc (e.g., flexural strength, water sorption, solubility, etc., as typically covered by these dental material standards). The results of these tests demonstrated compliance with the established thresholds within those international standards. The specific numerical performance values are not provided in this summary, only the statement of meeting the criteria.

2. Sample sized 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 specified in the provided summary. This type of information would typically be in the detailed test reports attached to the 510(k) submission, not in the summary document itself.
• Data Provenance: Not specified. Performance testing for material properties is typically conducted in a laboratory setting.

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 device is a material, not an AI/ML diagnostic or therapeutic device requiring expert interpretation for ground truth. Ground truth for material properties is established through standardized physical and chemical testing methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation outcomes, not for material property assessments.

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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would be the established acceptable ranges for physical and chemical properties as defined by the international standards ISO 10477:2004 (Dentistry — Polymer-based restorative materials — Provisional dental materials) and JIS T 6518:2011 (Dental polymethyl methacrylate materials for CAD/CAM system).

8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not involve a "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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