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The SprintRay High Impact Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.

Fabrication of dental prosthetics with High Impact Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.

The High Impact Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.

High Impact Denture Base Resin is intended exclusively for professional dental work. SprintRay High Impact Denture Base Resin is offered in following shades/colors:

• Light Pink .
• Original Pink ●
• . Light Meharry
• Original Meharry .
• . Dark Meharry

High Impact Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

The provided text describes the regulatory clearance for a dental resin, not an AI/ML powered device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and a study that proves the device meets those criteria for an AI/ML device.

However, based on the information provided for the SprintRay High Impact Denture Base, I can extract information related to its performance and equivalence to a predicate device. This information pertains to the physical and biocompatibility characteristics of the resin, not AI/ML performance.

Here's a summary of the performance data and equivalence to predicate devices, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the industry consensus standard ISO 20795-1 and the biocompatibility testing standards. The reported device performance indicates that the SprintRay High Impact Denture Base functioned as intended and the outcomes were as expected against these standards.

2. Sample size used for the test set and the data provenance:

• The document does not explicitly state sample sizes for each specific test (e.g., number of samples for flexural strength). It broadly states that "High Impact Denture Base was tested for conformity with the industry consensus standard ISO 20795-1." These standards typically specify sample sizes for their respective tests.
• Data provenance is not provided (e.g., country of origin, retrospective or prospective). The tests are laboratory-based bench and biocompatibility tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" for this device is based on established scientific and engineering standards (ISO standards) and laboratory test results, not expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set:

• Not applicable. This concept is relevant for studies involving human interpretation or clinical data, which is not the case here.

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 powered 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 powered device.

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

• The "ground truth" is defined by the performance specifications and methodologies outlined in recognized international standards for dental materials (e.g., ISO 20795-1 for physical properties, ISO 10993 for biocompatibility).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML powered device, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

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VarseoSmile Crown plus is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile Crown Plus material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.

VarseoSmile Crown plus is a light-cured, methacrylate-based resin used in 3D printers for the production of permanent crowns, inlays, onlays and veneers. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of permanent dental restorations such as inlays, onlays, veneers and full crown prosthetics in compatible 3Dprinters. Restorations fabricated using the Subject device are one-time use, permanent, prescription-only devices. VarseoSmile Crown is suitable for restoration of occlusal surfaces. VarseoSmile Crown is cured externally to the patient by light sources within a 3D printer and post-curing device. The Subject device is a viscous solution consisting of methacrylate-based resins, dental glass filler, 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.

This document is for a dental material (VarseoSmile Crown Plus), not an AI/ML powered medical device. Therefore, a table of acceptance criteria and reported device performance for an AI/ML device, as well as the other requested information related to AI/ML device studies (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance), are not applicable to the provided text.

The information provided focuses on demonstrating substantial equivalence of the dental material to predicate devices based on indications for use, technological characteristics, and non-clinical performance testing against established ISO standards for dental materials.

Here's a breakdown of the relevant information from the document regarding the device's acceptance criteria and how it was shown to meet them:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Device):

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