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Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

Glidewell™ 3DP Denture Base Resin is a light-cured resin for the fabrication of removable 3DP denture bases, including full and partial dentures, fabricated in a professional dental setting. The resin is compatible with DLP printers utilizing wavelengths of 405nm and is offered in G1 (standard pink), G3 (medium pink) and G4 (dark pink) shades formulated to match gingival tissue.

Here's a breakdown of the acceptance criteria and the study information for the Glidewell™ 3DP Denture Base Resin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for each test set (e.g., how many samples were tested for flexural strength, how many batches for shade match).

• Provenance: The data is non-clinical performance data generated by Prismatik Dentalcraft, Inc. The document does not specify country of origin for the data, but the company is based in Irvine, California, USA, and the tests were performed according to international standards (ISO). The studies are retrospective as they present results of completed tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a material (resin) that undergoes physical, chemical, and biological testing against established international standards rather than requiring expert interpretation of diagnostic output.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and based on established physical, chemical, and biological measurement protocols outlined in the ISO standards. The results are quantitative measurements compared against predefined numerical limits.

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 a material (resin) for dental applications, not an AI diagnostic or assistive device for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a material testing, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance of the Glidewell™ 3DP Denture Base Resin is based on consensus international standards. Specifically, ISO 20795-1: 2013 "Dentistry - Base polymers – Part 1: Denture base polymers" defines the performance criteria for physical properties, and ISO 10993-1:2018 and ISO 14971:2019 define the requirements for biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is a material, not a machine learning algorithm that requires a training set. The "training" for the material would be the research and development process to formulate the resin to meet the performance characteristics.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, this isn't an AI device with a training set. The "ground truth" for the material's development would be the target performance specifications derived from market needs, clinical requirements, and relevant standards.

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