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The GR-14.1 denture is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.1 denture is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

The GR-14.2 denture HI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.2 denture HI is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

GR-14 Resin System includes the GR-14.1 denture and GR-14.2 denture HI and is made of functional methacrylic resins and inorganic fillers. It is available in three shades based on the shade guide, orange-pink, light-pink and deep-pink. The resin is a liquid photo-curable material that is polymerized by image projection systems at 405nm to create denture baseplates. The GR-14 Resin System is intended to be used in conjunction with an additive Computer- Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems. Preformed teeth are fixed into the denture base by extra gluing process with appropriate glue material.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: GR-14 Resin System (GR-14.1 denture and GR-14.2 denture HI)

Intended Use: Light-curable polymerizable resin for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical targets for each performance standard. Instead, it states that performance testing was performed in accordance with specific ISO standards. This implies that meeting the requirements specified within these standards constitutes the acceptance criteria. The "Reported Device Performance" column therefore reflects that the device successfully met these standards, as a conclusion of "substantial equivalence" is drawn.

• Flexural Strength
• Flexural modulus / Bending module
• Bond Strength
• Color Stability
• Water Sorption and Solubility
• Fracture toughness
• Total Work of Fracture Testing |
  | ISO 22112 (Dentistry - Artificial teeth for dental prostheses) | Performed in accordance with ISO 22112, indicating compliance with requirements relevant to the resin system's properties for denture bases. |
  | Biocompatibility | |
  | ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Biocompatibility testing conducted in accordance with ISO 10993-1, indicating the device is biocompatible. |
  | Shelf-Life | |
  | ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages) | Shelf life of 2 years demonstrated through testing in accordance with ASTM F1980-16. |

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

The document does not specify the sample sizes used for the test sets in the performance, biocompatibility, or shelf-life studies. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The studies mentioned (performance, biocompatibility, shelf-life) are technical tests on material properties, not diagnostic studies requiring expert interpretation of results to establish "ground truth" in the way it's typically understood for AI/diagnostic devices.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The acceptance criteria are based on defined standards and physical/chemical testing, not on adjudicated expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and the study aims to assess the impact of AI assistance on their performance. The GR-14 Resin System is a material used for manufacturing dentures, not a diagnostic device.

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

This concept is not applicable to the GR-14 Resin System. This device is a material, not an algorithm. The performance tests are inherently "standalone" in that they evaluate the material's properties directly, not its interaction with a human operator beyond proper manufacturing and curing processes.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is defined by the specifications and limits within the cited ISO and ASTM standards. For example, flexural strength must meet a certain value specified in ISO 20795-1. For biocompatibility, the ground truth is simply whether the material passes the tests outlined in ISO 10993-1, indicating it does not elicit adverse biological reactions.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The GR-14 Resin System is a material, not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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