Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device