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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 Monochromatic colors and 20 multilayer colors all with varying thickness (14-40mm).

The provided document is a 510(k) summary for a dental device, "PuRE PMMA Disc". It details the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain the specific information required to address most of your questions about acceptance criteria and the study that proves the device meets them. This document is a regulatory submission for market clearance, not typically a detailed report of clinical study results.

Here's an analysis of what can and cannot be answered from the provided text:

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

The document states:

• "Physical Properties: Met the acceptance criteria of ISO 10477:2004 and JIS T 6518:2011"
• "Biocompatibility: Biocompatible"

However, it does not provide a table detailing the specific acceptance criteria from ISO 10477:2004 and JIS T 6518:2011, nor does it report the concrete performance values the device achieved against these criteria (e.g., specific flexural strength values, water sorption, etc.). It only mentions that the criteria were met.

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

This information is not available in the provided text. The document refers to "non-clinical performance tests," but does not specify sample sizes for these tests or the origin/nature of the data.

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 information is not applicable/provided. The document primarily discusses material properties and biocompatibility, not diagnostic performance requiring expert interpretation for ground truth. It refers to "dental professionals and technicians" for designing and manufacturing restorations, but this is about the use of the device, not the establishment of ground truth for performance testing in the context of this regulatory submission.

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

This information is not applicable/provided for the same reasons as #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

This information is not applicable/provided. This device is a dental material (PMMA disc), not an AI-assisted diagnostic tool.

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

This information is not applicable/provided as it relates to an AI algorithm, which this device is not.

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

The "ground truth" for the device's performance is based on standardized mechanical and material property tests as defined by ISO 10477:2004 and JIS T 6518:2011, and biocompatibility assessments. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device in the provided text for this submission.

8. The sample size for the training set

This information is not applicable/provided. This device is a physical product, not an AI model that requires a training set.

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

This information is not applicable/provided for the same reasons as #8.

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