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VarseoSmile TriniQ is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces. The VarseoSmile TriniQ material is used for fabricating permanent restorations such as inlays, veneers, full crown and bridge restorations. VarseoSmile TriniQ can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

The Subject device is a light-cured methacrylate-based resin used in 3D printers to produce permanent or dental restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary or permanent dental restorations. Restorations fabricated using the Subject device are one-time use, prescription-only devices. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties. The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

The provided text describes the acceptance criteria and study for the VarseoSmile TriniQ device. This device is a light-cured methacrylate-based resin used in 3D printers to produce dental restorations.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device was tested against and met the requirements of specific ISO standards. It mentions a flexural strength criterion.

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

The document does not specify the sample size used for the test set in terms of the number of dental restorations or materials tested for each performance criterion. It generally refers to "Physical property testing" and "Confirmatory testing" without providing specific numbers of samples.

The data provenance is non-clinical performance testing, meaning it's laboratory-based testing of the material's properties rather than human patient data. There is no mention of country of origin for the data; the testing is against international ISO standards.

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

This information is not applicable and therefore, not provided. The testing described is for material characteristics against engineering and biocompatibility standards, not for diagnostic accuracy or clinical outcomes that would require expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore, not provided. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not for laboratory material property testing.

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 and therefore, not provided. The device described is a dental restorative material, not an AI-powered diagnostic or treatment assistance tool. No MRMC study was mentioned.

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

This information is not applicable and therefore, not provided. The device is a material, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance testing is the established requirements and specifications defined by international ISO standards (e.g., ISO 4049, ISO 10477, ISO 22112, ISO 10993 series) and FDA guidance for MRI safety. For manufacturing process validation, the ground truth is the expected or desired output consistent with the process input.

8. The Sample Size for the Training Set:

This information is not applicable and therefore, not provided. This is a material, not a machine learning model, so there is no concept of a "training set."

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 mentioned, there is no ground truth to be established for it.

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FREEPRINT® crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces.

The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.

Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of temporary or permanent dental restorations such as crowns and bridges, inlays, veneers and full crown restorations including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary dental restorations.

Restorations fabricated using the Subject device are one-time use, prescription-only devices. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigments.

Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties.

The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

The provided document describes the FDA 510(k) premarket notification for the FREEPRINT® crown device, which is a light-cured methacrylate-based resin for 3D printing dental restorations. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FREEPRINT® crown are primarily based on meeting the requirements of recognized international standards for dental materials. The reported device performance is compared against these standards and against predicate/reference devices.

Note: For several parameters (Depth of Cure, Surface Finish, Flexural Strength, Water Sorption, Water Solubility), the document explicitly states that the FREEPRINT® crown meets the requirements of the listed ISO standards, but for some, it also provides specific values for the subject device or for the predicate/reference devices. The table above uses the explicitly stated acceptance thresholds where given.

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

The document does not specify the exact sample sizes (number of specimens) used for each non-clinical test (e.g., flexural strength, water sorption, biocompatibility). It states that "Physical property testing was performed on the Subject device to ISO 4049:2019...and ISO 10477:2018." These standards typically define the number of test specimens required for various mechanical and physical property evaluations.

Data Provenance: The data is primarily from non-clinical laboratory testing ("Non-clinical Performance Testing") conducted to support the substantial equivalence claim. The country of origin for the testing itself is not explicitly stated, but the manufacturer is DETAX GmbH, located in Germany, suggesting the testing might have been conducted there or in labs compliant with international standards. The document also mentions comparative material property testing performed with a "Reference device," implying some form of internal or contracted testing. This is retrospective data, as it was collected before the 510(k) submission.

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

This device is not an AI/Software as a Medical Device (SaMD) that diagnoses or interprets medical images, so the concept of "ground truth" established by experts in a clinical context (e.g., radiologists) is not applicable here. The "ground truth" for this device, which is a dental material, is defined by the objective, quantifiable physical, chemical, and biological properties measured against established international standards (ISO). The "experts" involved would be the material scientists, engineers, and chemists who conducted and interpreted the laboratory tests according to the specified standard operating procedures and test methods. Their specific number and qualifications are not detailed in this FDA letter, but it's presumed they possess the necessary expertise to perform these standardized tests.

4. Adjudication Method for the Test Set

Not applicable. Since the "ground truth" is defined by objective physical and chemical measurements against ISO standards for material performance, there is no need for an adjudication method as would be used in expert consensus for clinical image interpretation.

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

No. This document explicitly states: "The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical or animal testing data is included in this submission." Therefore, an MRMC study, which is a type of clinical study, was not performed. The device is a dental material, not an AI or imaging device where MRMC studies are typically relevant.

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

Not applicable. This is not an AI algorithm. Its performance is measured directly by its physical, chemical, and biocompatibility properties when fabricated into a dental restoration.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements of material properties according to established international consensus standards (ISO standards) for dental restorative materials. These include:

• Physical properties (e.g., flexural strength, water sorption, water solubility, depth of cure, surface finish).
• Chemical characterization of its composition.
• Biocompatibility testing results (cytotoxicity, sensitization, irritation, etc.).

8. The Sample Size for the Training Set

Not applicable. This is a material, not a machine learning algorithm, so there is no concept of a "training set" for an AI model. For material development, batches are produced and tested, but this is part of quality control and R&D, not an "AI training set."

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

Not applicable, as there is no training set in the context of an AI model. For the material's development and evaluation, the "ground truth" or acceptable parameters are set by the performance requirements outlined in the relevant ISO standards (e.g., ISO 4049, ISO 10477, ISO 10993 series). These standards represent an international consensus on the minimum performance and safety requirements for such dental materials.

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saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print CROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations. saremco print CROWNTEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

saremco print CROWNTEC is a resin-based material for the production of permanent and temporary restorations, veneers and artificial teeth on 3D printers. The material is an alternative to traditional heat-cured and auto polymerization resins. It requires a computer-aided and manufacturing (CAD/CAM) system including scanner, design software, additive printer and a post-curing unit.

The provided document does not contain information related to an AI/ML device or a multi-reader, multi-case (MRMC) study. The device, "saremco print CROWNTEC," is a light-curing 3D-printed material for dental restorations (e.g., crowns, inlays, veneers, artificial teeth).

The "study" described in the document is a non-clinical performance testing and biocompatibility evaluation of this dental material, specifically to demonstrate its substantial equivalence to predicate devices for FDA 510(k) clearance.

Therefore, I cannot provide answers to the requested information about acceptance criteria, study details, expert involvement, or AI/ML performance metrics, as these are not relevant to the described device and its evaluation process.

Instead, the document details the following:

• Acceptance Criteria (inferred from testing): The device (material) was tested and met the applicable requirements of the following ISO standards:
  • ISO 4049:2019 - Dentistry - Polymer-based restorative materials
  • ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials
  • ISO 22112:2017 – Dentistry – Artificial teeth for dental prostheses
  • ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
  • ISO 7405:2018 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry
• Reported Device Performance:
  • Flexural Strength: Average ≥ 135 MPa (compared to predicate devices ranging from > 50 MPa to 148.73 MPa).
• Study Type: Non-clinical bench testing and biocompatibility assessment.
• Ground Truth: The "ground truth" in this context refers to the established requirements and performance metrics defined by the aforementioned ISO standards, against which the material's properties were measured.
• Clinical Performance Data: The document explicitly states, "No human clinical testing was performed to support the substantial equivalence of saremco print CROWNTEC."
• Training Set/Test Set (as per ML context): Not applicable, as this is a material science characterization, not an AI/ML model development.
• Data Provenance: The tests were conducted by the manufacturer (Saremco Dental AG). Data provenance for the material properties would be from the laboratory tests.
• Experts and Adjudication: Not applicable in the context of an AI/ML study, but the ISO standards represent a consensus of expert knowledge in dental material science.

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