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3MIM Clinpro™ Clear 2.1% Sodium Fluoride Treatment is indicated for the treatment of hypersensitive teeth.

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is an aqueous fluoride coating that is applied topically to the tooth surfaces for the treatment of hypersensitive teeth. The product is sweetened with xylitol and sucralose. Clinpro 2.1% Sodium Fluoride Treatment contains 9,500 ppm fluoride and added calcium and phosphate. 3M Clinpro Clear 2.1% Sodium Fluoride Treatment uses the L-Pop™ unit dose dispensing system designed by 3M. Each L-Pop contains 0.5 ml (0.5 grams) of the coating and is offered in mint and melon flavors and a flavorless version.

The provided document is a 510(k) premarket notification for a medical device called "3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical trial to prove efficacy and safety through detailed acceptance criteria and studies as one might see for novel high-risk devices.

Therefore, the information typically available for a detailed acceptance criteria and performance study (as requested in the prompt) such as prospective studies, ground truth establishment by multiple experts with adjudication, MRMC studies, or standalone algorithm performance, is not present in this type of FDA submission.

Instead, the document details bench testing to demonstrate that the subject device performs similarly to or better than its predicate devices based on certain physical properties and release characteristics. The acceptance criteria here are mainly "Pass/Fail" based on whether the device meets specific thresholds or shows comparable performance to the predicate devices in these bench tests.

Here's an attempt to extract and present the available information in the requested format, with the understanding that many aspects of your request (e.g., human-in-the-loop studies, multi-reader studies, detailed expert ground truth, training set information) are not applicable or not provided in a 510(k) submission for a dental varnish.

Acceptance Criteria and Device Performance Study for 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment

Note: This 510(k) submission primarily relies on demonstrating substantial equivalence through bench testing against predicate devices, rather than clinical efficacy studies with human subjects. Therefore, many of the requested details, particularly those related to human reader studies, multi-expert ground truth establishment, and training/test set specifics for AI/ML models, are not applicable or not provided in this type of regulatory document for a tooth varnish. The "acceptance criteria" here refer to the performance thresholds set for the bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of patient data or clinical images, as the evaluation is based on in-vitro bench testing of the device material. The sample size for each bench test (e.g., number of replicates, number of specimens) is typically detailed in the internal test reports, but not provided in this summary. The data provenance is from laboratory bench testing conducted by 3M, not from specific patient populations or countries.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The "ground truth" for this device's performance is established by standardized laboratory testing methods and physical measurements, not by human expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" is material performance data from laboratory tests, no adjudication method is required.

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

No. This type of study (comparing human readers with and without AI assistance) is not applicable to a dental varnish product. This device is not an imaging AI or diagnostic tool.

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

Not applicable. This device is a physical product (dental varnish), not an algorithm or software. Its performance is evaluated through material science and physical property tests.

7. The Type of Ground Truth Used

The ground truth used is based on physical and chemical measurements and observations from in-vitro laboratory bench tests, conforming to established standards (e.g., ISO 17730-2020) or validated internal methods. For example, "visually occlude exposed dentin tubules" for SEM, or measurable fluoride release values.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a machine learning model, so there is no "training set" in the context of data for model development.

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

Not applicable. See point 8.

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3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping.

3M VitCal liner/base is a two-part paste/paste, light-cured system. The paste/paste materials are contained in a Micro-Mix Syringe Dispensing System. This dispensing system provides simultaneous dispensing and mixing of each component for a consistent mix and direct application into the mouth. The composition is a combination of a resin-modified glass ionomer and calcium-based material. The first paste contains a radiopaque fluoro-aluminosilicate glass and calcium filler. The second paste contains a modified polyalkenoic acid. VitCal liner/base provides the major benefits of glass ionomer cements including adhesion to the tooth structure and sustained fluoride release. Additionally, VitCal linerbase offers a high pH environment and a combination of a prolonged working time with an on-demand set time achieved by light curing.

The provided text is a 510(k) Premarket Notification for a dental product, 3M™ VitCal Liner/Base. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

It is important to note that this document is for a DENTAL LINER/BASE material, NOT an AI-powered medical device for diagnosis or image analysis. Therefore, the requested information regarding AI study design, such as MRMC studies, expert adjudication for ground truth, sample sizes for training/test sets in an AI context, and effect sizes of human readers with AI assistance, is not applicable to this submission.

The acceptance criteria and "study" proving the device meets them, in this context, refer to bench testing of physical, chemical, and biological properties (biocompatibility) to demonstrate that the new dental material performs comparably or acceptably to existing predicate devices.

Here's the relevant information extracted from the document, tailored to the type of device:

1. Table of Acceptance Criteria and the Reported Device Performance (Bench Test Results):

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

• Sample Size for Bench Tests: The specific number of samples (e.g., n=5, n=10) for each individual bench test (e.g., compressive strength, flexural strength) is not explicitly detailed in this summary. However, standard deviations are provided for most quantitative measurements (e.g., 103 ± 10), implying multiple replicates were used for testing. For "Dentin Tubule Occlusion," it states "Only 1 lot of 3M VitCal was tested."
• Data Provenance: The data is generated from laboratory bench testing of the dental material. The document does not specify a country of origin for the testing, but the submitting company (3M ESPE Dental Products) is based in St. Paul, MN, USA. The testing is prospective in the sense that it's performed specifically to characterize the device for this submission.

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

• This question is not applicable as the "test set" here refers to physical and chemical properties measured in a lab, not clinical images or patient data analyzed by experts.
• For biocompatibility assessment, it states: "A Diplomate of the American Board of Toxicology has assessed the safety of this product and has determined that it is safe for its intended use." This is an expert opinion on the safety, but not "ground truth" derived from patient data.

4. Adjudication Method for the Test Set:

• This question is not applicable as there is no expert reading or interpretation of "cases" involved. Performance is based on direct physical and chemical measurements.

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

• No, an MRMC study was NOT done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation, which is not the function of this dental liner/base material.

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

• No, this is not an algorithm. This is a physical dental material. The "standalone performance" is represented by the bench test results of the material itself.

7. The Type of Ground Truth Used:

• The "ground truth" for this device is based on established industry standards and physical/chemical measurements (e.g., ISO 9917-2 standards for dental cements, ASTM/ISO standards for mechanical properties, and analytical chemistry methods for ion release). For biocompatibility, it's based on toxicological assessments against established biological safety standards (e.g., ISO 10993).

8. The Sample Size for the Training Set:

• Not applicable. This device is a material, not an AI model requiring a training set.

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

• Not applicable. This device is a material, not an AI model, and therefore has no "training set."

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Permanent cementation of pediatric crowns:

• Stainless Steel crowns
• Zirconia crowns
• 3M™ Pediatric Esthetic Crowns

3MTM RelyX™ Pediatric Resin Modified Glass Ionomer Cement is a radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. RelyX Pediatric Cement is intended for the cementation of preformed pediatric crowns made of stainless steel, zirconia, and resin composite material.

RelyX Pediatric Cement consists of a base paste and a catalyst paste packaged in the Automix delivery system for direct delivery in consistent mix ratios. The mixing tip attachment offers convenience over traditional hand mixed cement systems and delivers consistent mix ratios. The cement is available in a white shade. The Automix syringe contains 8.5 g of cement material. The product provides both selfcuring and light curing mechanisms which makes it uniquely versatile for the cementation of different restorative materials.

Here's an analysis of the acceptance criteria and the study details for the 3M™ RelyX™ Pediatric Resin Modified Glass Ionomer Cement, based on the provided text:

Important Note: The provided document is a 510(k) summary for a dental cement. It does not describe an AI medical device, but rather a traditional medical device that undergoes physical and chemical performance testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested fields related to AI, such as sample sizes for test/training sets, data provenance, ground truth experts, adjudication methods, and MRMC studies, are not applicable and thus not present in this type of document.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the demonstration of "equivalent or superior bonding" and other physical properties compared to predicate devices. The document does not explicitly list numerical acceptance criteria in a table format for each property, but rather states that the "results submitted in the 510(k) demonstrated equivalent or superior bonding."

Here's a table based on the reported performance relative to predicate devices:

Study Details

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

   • Sample Size: Not explicitly stated for each test. The document mentions "data from in vitro testing," which typically involves multiple samples for each test (e.g., several samples per group for adhesion tests, compressive strength, etc.), but the exact number is not provided.
   • Data Provenance: The studies were in vitro testing. The country of origin of the data is not specified, but the submitter is 3M ESPE Dental Products, located in St. Paul, MN, USA. The testing was conducted to support a 510(k) submission to the U.S. FDA. The studies are by nature prospective in the sense that the manufacturer performed them to gain clearance for the device.

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

   • This is not applicable as this is not an AI/diagnostic device. The "ground truth" for material properties is established through standardized physical and chemical testing methods (e.g., ISO standards), not expert consensus.

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

   • Not applicable for this type of in vitro material performance testing. Standardized test methods and measurements are used, not human adjudication.

4. 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 medical device.

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

   • Not applicable. This is not an AI medical device.

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

   • For the physical and chemical properties (adhesion, strength, fluoride release, etc.), the "ground truth" is determined by the results obtained from standardized in vitro test methods (e.g., per FDA Guidance "Dental Cements - Premarket Notification" and ISO 9917-2:2017). For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993-1:2018.

7. The sample size for the training set:

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

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

   • Not applicable. This is not an AI medical device, so there is no "training set" or corresponding ground truth establishment process in that context.

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· Direct anterior and posterior restorations (including occlusal surfaces)
· Core build-ups
· Splinting
· Indirect restorations including inlays, onlays, and veneers

3MTM FiltekTM Universal Restorative, is a visible-light activated, restorative composite optimized to create esthetic anterior and posterior restorations. This material provides excellent strength and low wear for durability and improved esthetics with higher level of visual opacity. The shades are body like opacity enabling up to a 2mm depth-of-cure. The pink opaquer can be placed in 1mm thick increments. All shades are radiopaque. Filtek Universal Restorative is offered in the following shades: A1. A2, A3. A3.5. A4, B1. B2, D3. XW, and PO. The pink opaque shade option can be used to mask discolored or stained tooth structure.

Filtek™ Universal Restorative is packaged in traditional syringes, for dispensing restorative on a pad outside the mouth, and single-dose capsules for dispensing restorative intraorally. The capsules are dispensed using the 3M ESPE Restorative Dispenser. Capsules may be warmed up to 70°C/158°F for one hour in a commercial warmer prior to use.

This document is a 510(k) summary for a dental restorative material, not an AI/ML medical device. Therefore, it does not contain the information required to answer the prompt regarding AI model performance, acceptance criteria, or specific study details like MRMC comparative effectiveness studies, ground truth establishment for AI training/test sets, or expert qualifications for reviewing AI outputs.

The document primarily focuses on establishing substantial equivalence to a predicate device based on material composition, physical properties, and intended use for a traditional dental restorative. It outlines typical material property tests (e.g., Compressive Strength, Depth of Cure) for dental composites.

Therefore, I cannot provide the requested information based on the provided text.

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• Direct anterior and posterior restorations (including occlusal surfaces)
• Base/liner under direct restorations
• Core build-ups
• Splinting
• Indirect restorations including inlays, onlays and veneers
• Restorations of deciduous teeth
• Extended fissure sealing in molars and premolars
• Repair of defects in porcelain restorations, enamel, and temporaries

3MTM ESPETM FiltekTM Bulk Fill Posterior Restorative material is a visible-light activated, restorative composite optimized to create posterior restorations simpler and faster. This bulk fill material provides excellent strength and low wear for durability. The shades are semi-translucent and low stress curing, enabling up to a 5 mm depth-ofcure. With excellent polish retention, Filtek™ Bulk Fill Posterior Restorative is also useful for anterior restorations that call for a semi-translucent shade. All shades are radiopaque. Filtek™ Bulk Fill Posterior Restorative is offered in A.I. A2. A3. B1. and C2 shades. Filtek™ Bulk Fill Posterior Restorative is applied to the tooth following use of a methacrylate-based dental adhesive, such as manufactured by 3M™ ESPETM. which permanently bonds the restoration to the tooth structure.

Filtek™ Bulk Fill Posterior Restorative is packaged in traditional syringes, for dispensing restorative on a pad outside the mouth, and single-dose capsules for dispensing restorative intraorally. The capsules are dispensed using the 3M ESPE Restorative Dispenser.

This document is a 510(k) summary for a dental restorative material, not a medical imaging or AI-based device, so many of the requested criteria (e.g., sample size for test set, number of experts, MRMC study, training set information) are not applicable.

However, I can extract the acceptance criteria and performance as presented for the physical properties of the dental material.

Acceptance Criteria and Reported Device Performance for Filtek™ Bulk Fill Posterior Restorative:

The submission indicates that "Test results for the following physical properties were included in this submission: Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Volumetric Shrinkage, Wear, Depth of Cure, Cusp Deflection and Polish Retention."

The overall "acceptance criterion" for this 510(k) submission is Substantial Equivalence to the predicate devices. The document explicitly states:

"Filtek™ Bulk Fill Posterior Restorative is substantially equivalent to the predicate devices, Filtek™ Supreme Ultra Universal Restorative, SonicFill, Sonic-Activated Bulk Fill Composite and Tetric EvoCeram Bulk Fill in terms of intended use, indications for use, physical properties, and technological characteristics. FiltekTM Bulk Fill Posterior Restorative is substantially equivalent to the predicate device, Filtek™ Supreme Ultra Universal Restorative in terms of formulation."

The study that proves the device meets the acceptance criteria (i.e., is substantially equivalent) involves a comparison of its technological characteristics and physical properties against predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since specific numerical acceptance criteria (e.g., "Compressive Strength > X MPa") and corresponding reported performance are not detailed in this summary, the table will reflect the comparative nature of the substantial equivalence claim. The "acceptance criteria" here are essentially "similar to or better than predicate devices" for the listed properties.

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

• Sample Size: Not specified in the 510(k) summary. The document mentions "Test results for the following physical properties were included in this submission," implying laboratory testing, but does not provide specific sample quantities for each test.
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. As these are material property tests, they are typically conducted in a laboratory setting.

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

• Not applicable in the context of material property testing for substantial equivalence. The "ground truth" for material properties is established by adherence to recognized international standards (e.g., ISO).
• However, for biocompatibility, it states: "A Diplomate of the American Board of Toxicology assessed the safety of the product." This indicates at least one, highly qualified expert was involved in the safety assessment.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical diagnoses or interpretations, which is not the nature of this submission. The tests are based on objective physical measurements per ISO standards.

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 restorative material, not an AI-assisted diagnostic or imaging tool.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• The "ground truth" for the performance claims is based on International Standardization Organization (ISO) standards for dental materials. Specifically, ISO 4049 and ISO 6874 are mentioned for certain properties, and the ISO 10993 series and ISO 7405 for biocompatibility.

8. The sample size for the training set:

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

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

• Not applicable. (See #8)

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• Base under Class I and II direct restorations .
• Liner under direct restorative materials .
• . Pit and fissure sealant
• Restoration of minimally invasive cavity preparations (including small, ◆ non stress-bearing occlusal restorations)
• Class III and V restorations .
• . Undercut blockout
• Repair of small enamel defects .
• Repair of small defects in esthetic indirect restorations .
• Repair of resin and acrylic temporary materials .
• As a core build-up where at least half the coronal tooth structure is . remaining to provide structural support for the crown

Filtek™ Bulk Fill Flowable Restorative, is a low viscosity, visible-light activated, radiopaque, flowable. This low stress flowable material is semitranslucent enabling a 4mm depth of cure. The restorative is packaged in capsules and syringes. The shades offered with Filtek™ Bulk Fill flowable are U (Universal), A1, A2, and A3. Filtek™ Bulk Fill flowable contains bisGMA, UDMA, bisEMA(6) and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.1 to 5.0 microns and zirconia/silica with a particle size range of 0.01 to 3.5 µm. The inorganic filler loading is approximately 64.5% by weight (42.5% by volume). A dental adhesive is used to permanently bond the restoration to the tooth structure.

Filtek™ Bulk Fill Flowable Restorative is a modification of predicate device Filtek™ Supreme Ultra Flowable Restorative. The formulation was modified to increase depth of cure, while decreasing polymerization shrinkage stress.

The provided text describes a 510(k) submission for a dental restorative material, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details (sample size, data provenance, ground truth, MRMC study, standalone performance), and training set details for a device meeting acceptance criteria and proven by a study is not present.

The document focuses on demonstrating substantial equivalence of the Filtek™ Bulk Fill Flowable Restorative to predicate devices. This is achieved through bench testing of physical properties and an assessment of biocompatibility and risk management.

Here's an analysis of the provided text in relation to your request, highlighting what is not available:

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

• Not Available directly as a table for "acceptance criteria" and "reported device performance" in the AI/ML context.
• The document states: "This 510(k) submission includes data from bench testing to evaluate the performance of Filtek™ Bulk Fill Flowable Restorative compared to predicate devices Filtek™ Supreme Ultra Flowable Restorative, Adaptable Composite Resin Restorative Material and Revolution™ Formula 2. Standards utilized include ISO 4049.2009 and ISO 6874:2005. Properties evaluated include Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Cusp Deflection, Volumetric Shrinkage, Wear and Depth of Cure."
• The "acceptance criteria" here are implied to be meeting or being comparable to the performance of the predicate devices and relevant ISO standards for these physical properties. The reported device performance for each of these specific properties is not explicitly listed in the summary but would have been part of the full 510(k) submission.

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

• Not available. The document mentions "bench testing" but does not specify sample sizes for these tests, nor the "provenance" in terms of subject or data origin, as this is a material science evaluation, not a clinical study involving human 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/available. This section refers to AI/ML ground truth establishment. For this dental material, "ground truth" is established by standard material science testing and adherence to ISO standards.
• One "Diplomate of the American Board of Toxicology" assessed biocompatibility, which is a different type of expert review, not related to an AI/ML ground truth for a test set.

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

• Not applicable/available. Adjudication methods are relevant for expert consensus in AI/ML performance evaluation and are not described here 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/available. This is a question specifically for AI/ML devices. No human reader studies are mentioned, as the device is a dental restorative material, not an AI aid for diagnosis or treatment planning.

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

• Not applicable/available. This question is also specific to AI/ML algorithms.

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

• Not applicable/available in the AI/ML sense. The "ground truth" for this device's performance is based on established scientific measurement methods for material properties (e.g., compressive strength, depth of cure) as defined by ISO standards 4049.2009 and 6874:2005. Biocompatibility "ground truth" is derived from toxicology assessments and ISO 10993 and 7405 standards.

8. The sample size for the training set:

• Not applicable/available. There is no "training set" as this is not an AI/ML device.

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

• Not applicable/available. There is no "training set."

In summary, the provided document describes the 510(k) submission for a non-AI dental material. Therefore, most of the requested information pertaining to AI/ML device evaluation criteria and study design is not present or applicable. The document focuses on demonstrating substantial equivalence based on material properties, biocompatibility, and risk management through bench testing and adherence to established standards, rather than clinical efficacy through human evaluations or AI model performance.

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This device is intended for use as a dental cement. RelyX™ Luting Plus Automix (Lexus-2) is indicated for Luting:

• Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups;
• Luting metal inlays, onlays or crowns;
• Luting pre-fabricated and cast post cementation
• Luting orthodontic appliances
• Luting crowns made with all-alumina or all zirconia cores such as Procera® AllCeram

3M™ ESPE™ RelyX™ Luting Plus Automix (Lexus-2) is a radiopaque, fluoride-releasing, resinmodified glass ionomer luting cement. It is self-curing with an option for tack light curing of excess cement. RelyX Luting Plus Automix (Lexus-2) consists of a base (Paste A) and catalyst (Paste B) packaged in an automix (dual barrel) syringe. The dual barrel syringe dispenses paste A and Paste B. The cement is available in a white shade.

The provided text describes the acceptance criteria and a study demonstrating that the device, RelyX™ Luting Plus Automix, meets these criteria.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by comparing the performance of the new device (RelyX™ Luting Plus Automix, referred to as Lexus 2) against a legally marketed predicate device (3M™ ESPE™ RelyX™ Luting Plus Cement, K022476). The reported device performance is indicated by "pass" for all tested properties, signifying that Lexus 2 met or exceeded the design specifications, which are implicitly acceptable as they are compared to a predicate device.

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The product is indicated for inlays, onlays, veneers, and full crown restorations, including crowns on implants.

The product is a strong, wear-resistant and highly esthetic mill block that provides a fast and easy-to-use alternative to porcelain blocks for milling CAD/CAM indirect restorations. The material is specially processed to enhance its properties for use in CAD/CAM milling procedures.

The provided text describes a 510(k) submission for a dental restorative material, not a software or AI-powered medical device. Therefore, the information requested about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies, human reader improvement, standalone performance, and training set information) is not applicable or cannot be extracted from this document.

The document primarily focuses on demonstrating substantial equivalence to predicate dental devices through bench testing of physical properties.

However, I can extract the general "acceptance criteria" in the context of this device being approved based on comparison to predicates and meeting certain material properties.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for each test. The document states "data from bench testing" was used.
• Data Provenance: Bench testing, likely conducted by 3M ESPE Dental Products. No information about country of origin, retrospective or prospective is relevant as it's a material test.

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. This is a material science study, not one requiring expert human interpretation for "ground truth" as you would find in an imaging or diagnostic device. The "ground truth" here is the measured physical properties of the material and its comparison to established predicate devices.

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

• Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for bench testing of material properties.

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-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-powered device.

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

• The ground truth for this type of material device is derived from standardized bench test measurements of physical and chemical properties and comparison to the established performance of legally marketed predicate devices. Biocompatibility was assessed through a "risk assessment techniques and consideration of FDA & internationally recognized guidelines."

8. The sample size for the training set:

• Not applicable. This is not an AI-powered 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-powered device.

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• Treatment of hypersensitive teeth
• Use on exposed dentin and root sensitivity
• Under temporary restoratives and cements where post-operative sensitivity is of concern

Vanish Varnish is a topically applied, flavored cavity varnish containing sodium fluoride and calcium phosphate in a rosin based preparation. The varnish is an insoluble viscous liquid that forms a film on tooth surfaces.

The provided text is a 510(k) summary for the Vanish™ Varnish, 5% Sodium Fluoride White Varnish. It details the device's classification, predicate devices, description, and intended use. However, it does not contain any information about acceptance criteria, study methodologies (like sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or training set details.

The document mainly focuses on establishing substantial equivalence to previously marketed predicate devices based on properties, intended use, and composition. It mentions that "The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405." This indicates some testing was done for safety, but not for effectiveness or performance metrics that would typically involve a multi-reader, multi-case study or a standalone algorithm performance test.

Therefore, I cannot provide the requested information. The document primarily confirms the device's features and its equivalence to other legally marketed devices as per the 510(k) submission process, rather than detailing specific performance studies with acceptance criteria for an AI/ML powered device.

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1. Lining and basing applications under composite, amalgam, ceramic or metal restorations.
2. Treatment of exposed root surface sensitivity
3. Site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions

GILB-2, Glass Ionomer protective coating is classified as Dental Cement (21 C.F.R§872.3275) because it is a device intended to provide protection as a cavity liner/basing material as well as in treatment of exposed root surfaces hypersensitivity. GILB-2 is a site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions.

GILB-2 is a two part liquid/paste system. The liquid/paste materials are contained in the Clicker™ Dispensing System manufactured by 3M ESPE. This dispensing system provides simultaneous dispensing of each component for a consistent mix.

The chemical composition is similar to predicate glass ionomer dental cement devices. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405.

The performance testing results provided in the submission confirms the performance as substantially equivalent to the predicate devices with common indications.

The provided text is a 510(k) summary for a dental cement device named GILB-2. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on chemical composition and performance testing. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics from any clinical or performance studies.

Therefore, I cannot provide the requested information in the format specified because the input text does not contain that level of detail.

Here's why and what can be inferred:

• Acceptance Criteria and Reported Device Performance: This information is completely absent. The document states "The performance testing results provided in the submission confirms the performance as substantially equivalent to the predicate devices with common indications," but no actual criteria or results are listed.
• Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and training set ground truth: All of these details relate to specific performance studies, whether clinical or non-clinical, that would have been conducted to demonstrate substantial equivalence. These details are not present in the 510(k) summary provided.

In summary, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth methods is available in the provided document. The document focuses on regulatory classification, device description, and claiming substantial equivalence to predicate devices generally, rather than detailing the specific studies used to demonstrate that equivalence.

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