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Insure® Universal
Cementation of ceramic and composite veneers, inlays and onlays with a thickness

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a dental cement product (Insure® Universal; Insure® Universal Automix).

This letter primarily focuses on:

• Device Clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: Details about regulations (e.g., 21 CFR 872.3275 for Dental Cement, Quality System regulation 21 CFR Part 820), responsibilities of the manufacturer (listing, labeling, adverse event reporting, good manufacturing practices), and guidance documents.
• Indications for Use: What the dental cement is intended to be used for (e.g., cementation of ceramic and composite veneers, inlays, onlays, crowns, and bridges).

There is no mention of specific performance metrics, acceptance criteria tables, study designs (sample sizes, retrospective/prospective, number of experts, adjudication methods, MRMC studies, standalone performance), or how ground truth was established for any AI or software-related device. The product mentioned is a physical dental cement, not an AI software or a device that would typically involve the types of studies you are asking about (like imaging devices with AI assistance).

Therefore, I cannot fulfill your request based on the provided text.

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Renamel Microhybrid

• · Anterior restorations (Class III and IV)
• · Deep Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• · Restorations in the posterior region (Class I and II)
• · Veneering of discolored teeth
• · Closing of diastemas by vestibular veneering
• · Repair of composite and ceramic veneers

Renamel Flowable Microhybrid

• · Class V restorations
• · Sealing margins
• · Repairing pitted areas in hybrid restorations
• · Small occlusal and lingual repairs
• · In deep Class V restorations to block out shine through prior to overlay with Renamel Microfill or Renamel Microhybrid

Not Found

This document is an FDA 510(k) clearance letter for dental restorative materials (Renamel® Microhybrid and Renamel® Flowable Microhybrid). It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter confirms that the devices are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) from this document.

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1. Direct Posterior Restorations (including occlusal surfaces)
2. Replacement of individual cusps
3. Base-liner under direct restorations.
4. Restorations of deciduous teeth
5. Class V restorations (cervical caries, root erosion, wedge-shaped defects)

Not Found

I am sorry, but the provided text is an FDA clearance letter for a dental resin material, "Renamel Bulkfill". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding:

• Acceptance criteria for a device performance study.
• Details of a study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• How ground truth for a training set was established.

This document is solely a regulatory clearance for a physical dental product (filling material), not a software or AI-driven diagnostic device that would typically undergo the types of studies you are asking about.

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Renamel® Microfill is intended to be used to create lifelike dental restoration.

Indications for Use:
Renamel® Microfill is designed for,

• Direct anterior veneers
• Anterior Class III and IV restorations
• Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• Closing of diastemas
• Repair of composite and ceramic veneers
• Top layer of Class I and II restorations

Renamel® Microfill is light-cured, microfilled, highly polishable dental restorative material. According to the applicable FDA recognized consensus standard ISO 4049 - "Dentistry -Polymer-based restorative materials", this device is classified as Type 1, Class 2, Group 1: Polymer-based restorative materials, involving occlusal surfaces, which uses external energy source for intra-orally curing. Renamel® Microfill consists of multi-functional acrylic Resin and fillers of 0.04 - 0.2 micron sized particles of inorganic and prepolymerized composite (70% by weight, 60% by volume). These devices possess physical and mechanical properties that allow them to function in the oral cavity with esthetic quality that mimics natural enamel surface.

This document describes the premarket notification for the Renamel® Microfill dental restorative material. The acceptance criteria and supporting study details are primarily focused on the physical and mechanical properties of the material, demonstrating its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for each specific test (e.g., number of specimens for depth of cure, flexural strength, etc.). However, it does refer to the ISO 4049:2009 standard for testing polymer-based restorative materials, which would inherently dictate the sample sizes required for statistically sound testing. The data provenance is not specified, but it can be inferred that these are in-house laboratory tests conducted by Cosmedent, Inc. or a contracted testing facility to comply with the referenced ISO standard. The data is retrospective in the context of this submission, meaning the tests were performed before the submission to demonstrate compliance.

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

This information is not applicable to this document. The "ground truth" for the performance criteria of a dental restorative material is established through objective, standardized physical and mechanical property testing according to international standards (ISO 4049). It does not involve expert consensus in the same way clinical diagnostic studies might.

4. Adjudication Method for the Test Set:

This information is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For material property testing, the results are typically quantitative measurements.

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 to this document. MRMC studies are relevant to diagnostic devices involving human interpretation of medical data, often with AI assistance. This document pertains to a dental restorative material, which is not a diagnostic device and does not involve "human readers" in the context of interpretation.

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

This information is not applicable to this document. This refers to the performance of an AI algorithm independently. The Renamel® Microfill is a physical dental material, not an AI algorithm.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating compliance is based on objective, quantitative measurements of physical and mechanical properties derived from standardized laboratory tests as defined by ISO 4049:2009 and other general material testing standards (e.g., for compressive strength and modulus of elasticity). This is equivalent to established scientific and engineering standards for material performance.

8. The Sample Size for the Training Set:

This information is not applicable to this document. "Training set" refers to data used to train machine learning models. The Renamel® Microfill is a physical product, and its development and testing do not involve machine learning training in this context.

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

This information is not applicable for the same reason as point 8.

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Renamel® NANO™ +plus is designed for,

• Class I-V dental restorations ●
• Direct veneering of anterior teeth
• Splinting
• Repair of composite or ceramic restorations ●

Renamel® NANO™ +plus is a light-cure composite resin fabricated from multifunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.

The provided document describes a 510(k) premarket notification for a dental resin material, Renamel® NANO™ +plus. It focuses on demonstrating substantial equivalence to a predicate device, Renamel® NANO™ (K070583), rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/human reader performance study.

Therefore, many of the requested details for an AI-medical device study (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document. This document primarily focuses on bench testing for physical and chemical properties and biocompatibility to demonstrate equivalence.

Here's a breakdown of the information that can be extracted and how it relates to the prompt, along with explanations for the information that is not available:

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

The document provides a table comparing several physical and mechanical properties of the new device (Renamel® NANO™ +plus) against its predicate (Renamel® NANO™), including "Specification" which can be interpreted as the acceptance criteria for these properties based on ISO standards.

Study Proving Device Meets Acceptance Criteria:

The study presented is a comparative laboratory testing of physical and mechanical properties and a toxicological evaluation to demonstrate biocompatibility. The purpose is to show substantial equivalence to an existing predicate device, not necessarily to meet a standalone clinical performance criterion for an AI system.

Information NOT available in the document (and why):

The following points are relevant for AI/Machine Learning medical device studies, which this document is not. Therefore, the information is not provided.

• 2. Sample sized used for the test set and the data provenance: This document describes bench testing of materials, not a study involving patient data or images with a test set of cases. The "sample size" would refer to the number of material specimens tested for each property, but this specific detail (e.g., n=X for flexural strength tests) is not explicitly stated. Data provenance (country, retrospective/prospective) is not applicable.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized laboratory methods (e.g., ISO standards), not expert consensus from clinicians.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the physical and mechanical properties is established through adherence to specified ISO standards (e.g., ISO 4049:2009) and other accepted laboratory testing methodologies for dental materials. For biocompatibility, it's based on toxicological evaluation and biocompatibility tests (10993-xx).
• 8. The sample size for the training set: Not applicable. This document is not about an AI/ML model needing training data.
• 9. How the ground truth for the training set was established: Not applicable.

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BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, appiration of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.

The applicant device is a Brushable Dental Composite, classified as a Tooth Shade Resin Material. It is a low viscosity microfilled composite with a filler percentage of 36%. It is supplied as preloaded, plastic syringes. The material is extruded onto a suitable pad or well and applied to the instrument.

This document is a 510(k) summary for a dental composite, not a study report for a medical device with acceptance criteria and performance data in the typical sense of AI/ML or diagnostic devices.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided text, addressing the applicable points:

This document describes a 510(k) submission for a dental material (Brushable Composite) seeking substantial equivalence to a predicate device. It is not a clinical study report for a diagnostic or AI-powered medical device where performance metrics like sensitivity, specificity, or inter-reader agreement are typically established against predefined acceptance criteria.

Applicable Information from the Provided Text:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The primary "acceptance criterion" for a 510(k) dental material is demonstrating substantial equivalence to a legally marketed predicate device. This is primarily assessed through comparison of intended use, composition, physical/mechanical aspects, and how the product is supplied and used. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
   • Reported Device Performance (Comparative Information): The provided table compares the applicant device (Cosmedent BRUSHABLE COMPOSITE) to the predicate device (Bisco SCULPTING RESIN). This table serves as the basis for demonstrating substantial equivalence rather than reporting explicit performance metrics against numerical acceptance criteria.

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

   • Not Applicable. This document describes a comparison to a predicate device based on material characteristics, not a clinical study with a "test set" of patient data.

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. There is no "ground truth" derived from expert review of a test set in this 510(k) submission. The ground for equivalence relies on material science comparisons.

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

   • Not Applicable. No test set or expert adjudication process is described.

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 dental material, not an AI-assisted diagnostic device.

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

   • Not Applicable. This is a dental material, not an algorithm.

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

   • Not Applicable in the traditional sense. For this 510(k), the "truth" is established by comparing the physical, chemical, and functional properties of the new device to those of the predicate device, typically using standardized material testing methods relevant to dental composites (which are not detailed in this summary). The FDA's determination of "substantial equivalence" is the regulatory ground truth.

8. The sample size for the training set:

   • Not Applicable. No "training set" is involved as this is not an AI/ML device.

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

   • Not Applicable. No "training set" or corresponding ground truth establishment is applicable here.

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NANO COMPOSITE is designed for Class I-V dental restorations, direct veneering of anterior teeth, splinting, and repair of composite or ceramic restorations.

Cosmedent NANO COMPOSITE is a light-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.

The provided text is a 510(k) summary for a dental composite material, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable.

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, Tetric EvoCeram. This involves comparing key physical and mechanical properties.

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

Not applicable. This is a material comparison study, not an AI/ML diagnostic study with a "test set" in that context. The data would have been generated from laboratory testing of the material. The document does not specify the sample sizes (e.g., number of specimens tested for each property) or data provenance in terms of country of origin, or if it was retrospective or prospective.

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

Not applicable. Ground truth in the context of AI/ML diagnostics for medical images is not relevant here. The "ground truth" for material properties is established through standardized laboratory testing methods.

4. Adjudication method for the test set

Not applicable. No expert adjudication is described for 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

Not applicable. This is not an AI/ML diagnostic 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 diagnostic device.

7. The type of ground truth used

The "ground truth" for the device's performance is based on the results of physical and mechanical properties testing performed according to implied standard laboratory methods.

8. The sample size for the training set

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

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

Not applicable. This is not an AI/ML device.

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Temporary CROWN AND BRIDGE Resin is indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations.

Cosmedent TEMPORARY CROWN AND BRIDGE RESIN is a self-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials have sufficient physical properties to function in the oral cavity for up to 90 days and have esthetic qualities that mimic natural tooth appearance.

The provided text describes a 510(k) submission for a medical device, a Temporary Crown and Bridge Resin. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving new performance against acceptance criteria through a clinical study of the type usually associated with AI/software devices. Therefore, many of the requested points related to AI/software performance studies are not applicable to this document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" in this context are the physical and mechanical properties of the predicate device (Luxatemp) that the applicant device (Cosmedent TEMPORARY C&B Filling Material) aims to be substantially equivalent to. The reported performance is the measured properties of the Cosmedent device.

2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to material properties testing, not a clinical study with a "test set" in the context of AI/software or diagnostic performance. The testing would have been conducted in a laboratory setting. No information on the number of samples tested for the material properties is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties like compressive strength is established through standardized laboratory testing methods, not expert consensus.

4. Adjudication method for the test set: Not applicable. Material properties are measured objectively.

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/software device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/software device.

7. The type of ground truth used: For the material properties (compressive strength, flexural strength, percent filler by weight, radiopacity), the ground truth is established through objective laboratory measurements following established standards for dental materials.

8. The sample size for the training set: Not applicable. This is not an AI/software device with a training set.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/software device.

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The product is used either by a dental professional in the dental office or by a patient at home to treat dentin sensitivity.

Cosmedent TOOTH DESENSITIZER is a 3% potassium nitrate and 1200 ppm fluoride ion gel desensitizer. The indication for this product is tooth discomfort caused by dentine sensitivity. TOOTH DESENSITIZER is a gel desensitizer device based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity due to patent dentinal tubules. TOOTH DESENSITIZER is available as a clear, green-colored, gel. It can be used either by gently brushing the affected area with the product or it can be used in a custom tray.

The provided text is a 510(k) premarket notification for a tooth desensitizer. It details the device's description, intended use, and comparison to a legally marketed predicate device.

However, the document does not contain any information regarding clinical studies, performance data, acceptance criteria, sample sizes (for test or training sets), expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The 510(k) summary (from document {0}) states: "TOOTH DESENSITIZER is a gel desensitizer device based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity due to patent dentinal tubules." This implies that the device's effectiveness relies on the known mechanisms of its active ingredients, rather than new clinical trials specifically for this product to prove novel efficacy beyond what is already established for these ingredients.

Therefore, I cannot populate the table or answer most of the questions you've posed, as the necessary information is not present in the provided text.

Here is what can be inferred or stated from the provided text:

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

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: Not specified as quantitative performance metrics. The document states it is "based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity," suggesting reliance on established scientific literature for its active ingredients rather than new performance data.

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

• Not specified. No test set data appears to have been presented.

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 specified. No ground truth establishment for a test set is mentioned.

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

• Not specified. No test set adjudication is mentioned.

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 medical device (tooth desensitizer), not an AI/imaging device.

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

• Not applicable. This is a medical device (tooth desensitizer), not an AI/imaging device.

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

• Not specified directly. The submission relies on "well documented effects of potassium nitrate and fluoride ion on dentine sensitivity," implying that the ground truth for their efficacy is based on existing scientific and clinical understanding of these active ingredients.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable. No training set is mentioned.

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Resin Tooth Bonding Agent is used to facilitate the adhesive bonding of restorative/preventive dental materials to dental hard tissues as well as to other restorative materials.

Cosmedent Resin Tooth Bonding Agent is a dual-cure 4th generation resin tooth bonding agent based on an acetone solution of room temperature polymerizing dimethacrylates. The device consists of two bottles designated as Primer A and Primer B. Primer A can be used alone and light cured, or it can be mixed with Primer B whereupon the adhesive will self cure in a clinically appropriate amount of time. In either case, two coats of the adhesive are applied to the prepared teeth. The adhesive bond strength of the device is approximately 25 MPa. The product is intended to be used to promote the adhesion of resin composite restoratives to dentin and enamel.

This device, Cosmedent Resin Tooth Bonding Agent, is a dual-cure 4th generation resin tooth bonding agent. The provided text indicates it's a 510(k) submission, meaning the manufacturer is demonstrating that their new device is substantially equivalent to a legally marketed predicate device. This type of submission relies on comparison to a predicate device rather than extensive new clinical trials to establish safety and effectiveness. Therefore, the information typically found in a clinical study report proving acceptance criteria is not present in this document.

However, based on the provided text, we can infer some "acceptance criteria" through the comparison made to the predicate device, Bisco All-Bond 2 (K910860). The primary performance metric mentioned for both the applicant and predicate device is adhesive bond strength.

Here's the breakdown of the information requested, based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are inferred from the performance of the legally marketed predicate device. For a 510(k), substantial equivalence implies that the new device's performance should be comparable to or not worse than the predicate's performance in clinically relevant aspects.

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

The document does not detail specific sample sizes for testing or data provenance for the reported bond strength values. 510(k) submissions often rely on bench testing and comparisons to predicate devices, rather than large-scale clinical trials. The reported bond strength values (25 MPa and 28 MPa) would typically come from in-vitro (bench) testing.

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

Not applicable. The document does not describe the establishment of a "ground truth" using experts for the reported bond strength. These values are typically derived from standardized material testing in a laboratory setting.

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

Not applicable. The document does not describe an adjudication method as no expert-based review or clinical trial is detailed for the bond strength measurements.

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 device is a dental bonding agent, a physical material, and does not involve AI or human "readers." Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a dental bonding agent, not a software algorithm.

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

The "ground truth" for the reported bond strength is derived from physical/material testing (e.g., tensile or shear bond strength tests) typically conducted in a laboratory setting according to recognized standards (e.g., ISO standards for dental materials).

8. The sample size for the training set

Not applicable. As a material device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no "training set" for this device.

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