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Hard Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.

Thermo-adaptive Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.

Whip Mix Dental Resin is light cured resin that is provided in a plastic container, and it is a proprietary blend of ingredients that make a generative resin. When the system (which includes a scanner, design software, printer software, resin, 3D printer, and curing unit) are used in combination, the result is an additive manufactured orthodontic, thermo-flexible orthodontic, or dental appliances such as mouthguards, splint, nightguards, repositioners and retainers.

The provided text describes a 510(k) premarket notification for two light-curable resins, "Hard Splint" and "Thermo-Adaptive Splint," for fabricating dental appliances. It mainly focuses on the substantial equivalence to predicate devices based on technological characteristics and non-clinical tests. However, it does not contain information related to software performance, AI algorithms, human-in-the-loop studies, or the acceptance criteria for such systems.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI or software, nor can I answer questions about sample sizes for test sets, data provenance, expert-established ground truths, adjudication methods, MRMC studies, standalone algorithm performance, or training set details. This document pertains to the material properties and biocompatibility of the resins, not the performance of a diagnostic or analytical device with acceptance criteria involving sensitivity, specificity, or other performance metrics typically associated with AI.

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Whip Mix VeriSplint is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.

The VeriSplint ®OS system is a combination of a scanner, resin, 3D printer, and curing unit. The system components work together to manufacture a splint/bite guard. The additive manufactured appliance is part of a photo-cured product family that is a combination of methacrylate resins. In general, the products in this family are composed of a 3-component methacrylic system, polymerized via photo initiators in a 3D printer setting. The material is an alternative to traditional heat cured and auto polymerizing resins.

The provided text describes the Whip Mix VeriSplint device and its performance testing to demonstrate substantial equivalence to predicate devices, primarily for its physical and chemical properties as a dental material. It does not describe a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or MRMC studies, as would be common for AI/ML-based medical devices.

Therefore, many of the requested elements for the acceptance criteria and study proving device performance (specifically those related to AI/ML and human reading studies) are not applicable to the information provided in this document.

Here's the information that can be extracted from the provided text, focusing on the material characteristics and the regulatory review process for VeriSplint:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on the requirements of ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers, and comparison to predicate devices.

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Vericore ® Gradient Temporary discs is a device made from Polymethylmethacrlate. It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology.

Vericore ® Gradient Temporary Discs is a device made from high quality PMMA (polymethylmethacrylate) that is >98%. It is intended for use in the oral cavity as a temporary restoration up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed by the dental technician using CAD technology and uses scans or models from the basis of the restoration to be milled. Vericore ® Gradient Temporary Discs are circular in form and available in a variety of thicknesses for different milling systems and are also available in Vita shades of A1, A2, A3, B1, B2, and Bleach. The device is fabricated in the standard dental laboratory environment.

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

Device: Vericore® Gradient Temporary Disc (K152443)
Predicate Device (Primary for performance): Copra-Temp discs manufactured by White Peaks Dental Systems (K131664)

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance data primarily in comparison to a predicate device, and against ISO standards. The acceptance criteria are implicitly derived from the ISO standard requirements.

Summary of Device Performance against Acceptance Criteria:

• Flexural Strength: The device's reported flexural strength (82 MPa) meets the minimum requirement of 50 MPa per ISO 10477.
• Chemical Solubility & Water Sorption: The document states that "all tests passed the requirements" for these two characteristics according to ISO 10477. The specific numerical acceptance criteria from the ISO standard are not explicitly listed, but the reported values (-0.2 µg/mm³ for solubility and 22 µg/mm³ for water sorption) are provided in comparison to the predicate. The statement "all tests passed the requirements" implies these values were within acceptable limits.
• Biocompatibility: The device demonstrated no irritation effects on test subjects for the oral mucosa, indicating it met the biocompatibility requirements related to its specific shading ingredients.

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

• Sample Size for Test Set: Not specified in the provided document. The tests conducted (Flexural Strength, Water Sorption, Chemical Solubility, Biocompatibility focusing on irritation effects) would have involved specific numbers of samples, but these are not detailed.
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective nature. The testing was conducted by Whip Mix Corporation ("Whip Mix performed biocompatibility test...") for the specific shading ingredients, or referenced predicate data based on similar testing ("same tests as performed on the predicate K131664" and "White Peaks performed biocompatibility tests").

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

• This information is not applicable to this type of device and study. The testing described (mechanical properties and biocompatibility) relies on objective measurement and laboratory analysis, not expert consensus or interpretation of subjective data like images. There is no "ground truth" established by experts in the context of diagnostic accuracy for this device.

4. Adjudication Method for the Test Set

• This information is not applicable as there is no "adjudication" in the context of mechanical properties or biocompatibility testing for this device. The results are based on objective measurements against defined standards.

5. If a Multi Reador Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting cases (e.g., radiology AI). The Vericore® Gradient Temporary Disc is a dental material, not a diagnostic imaging device.

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

• No, a standalone algorithm-only performance study was not done. This device is a physical material, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For Flexural Strength, Chemical Solubility, and Water Sorption: The "ground truth" (or reference standard) is established by physical measurements according to the protocols defined in ISO 10477.
• For Biocompatibility: The "ground truth" is established by biological response assessments (e.g., observing for irritation effects) conducted according to relevant parts of the ISO 10993 series (specifically mentioned: ISO:10993-3, ISO:10993-5, and ISO:10993-10 for the predicate, and performed for oral mucosa irritation for the new device).

8. The Sample Size for the Training Set

• This concept is not applicable. This device is a physical dental material, not a machine learning model that requires a "training set."

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

• This concept is not applicable as there is no training set for this type of device.

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Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with many CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;

• Zirconia Substructures .
• -Restorations (Including inlays, onlays, and veneers)
• . Crown Framework in the Anterior and Posterior regions
• . Bridge Framework in the Anterior and Posterior regions

Vericore Zirconia Blanks is a device made from pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.

The provided text is a FDA 510(k) premarket notification for a dental device, "Vericore Zirconia Blanks". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device's performance against specific acceptance criteria in a clinical setting. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a clinical study is not available in the provided text.

However, I can extract information related to the bench testing conducted.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for the bench tests.
• Data Provenance: Not specified, but generally, bench testing data for medical devices would originate from the manufacturer's testing facilities (likely in the USA, given the applicant's address). The tests are prospective in nature as they are conducted for this specific submission.

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. Bench testing does not typically involve human experts for establishing ground truth as it measures material properties based on established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Bench testing does not involve adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This document is for a physical dental material, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No, a standalone performance study was not done. This document is for a physical dental material, not an algorithm.

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

• For the bench tests (Flexural Strength, Chemical Solubility, Density), the "ground truth" is based on established international standards (ISO 6872) for material properties.

8. The sample size for the training set

• Not applicable. This is a physical dental material, not a machine learning algorithm, so there is no "training set."

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

• Not applicable. There is no training set for a physical dental material.

In summary, the provided document details the regulatory submission for a dental material (Vericore Zirconia Blanks). The "study" described refers to bench testing to ensure the material meets specified physical and chemical properties according to international standards (ISO 6872). It does not involve a clinical study with human subjects, expert readers, or AI performance metrics.

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