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Calcium Bridge is a resin-based composite recommended for use as a liner or initial layer beneath all composite resins, or as flowable composite in preventive resin restorations. For Use only by a Licensed Dentist. Rx Use Only.

Calcium Bridge is a resin-based, flowable polymerizable composite paste recommended as a lining material beneath composite resins or as a preventive resin restoration (PRR) material (a minimally invasive procedure to protect a tooth). A PRR restoration is not intended to prevent caries but intended to be used in the treatment of caries. Because Calcium Bridge is highly radio-opaque this allows for easy radio-graphic observation compared to enamel, dentin, and possible secondary caries.

This document is a 510(k) summary for a dental device called "Calcium Bridge." It compares the device to a predicate device, "Tetric EvoCeram," to demonstrate substantial equivalence. It does not contain information about a study proving the device meets acceptance criteria related to AI or digital image analysis. Therefore, it's not possible to provide the requested information.

The document discusses the following properties, which could be considered acceptance criteria for a dental material:

Table of Acceptance Criteria and Reported Device Performance (as inferred from the provided test values):

Missing Information (based on your request, but not present in the document):

The document does not describe a study involving human readers, AI, or ground truth establishment in the context of diagnostic performance. Therefore, I cannot answer the following parts of your request:

• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

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Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues. For Use only by a Licensed Dentist. Rx Use Only.

Triumph Resin Dam is a light-cured, resin dam material recommended to block out or protect dental materials or tissues. Triumph contains polymerizable monomers that when light-cured form a protective barrier. When set the resin has a low strength allowing its removal from the protected surfaces.

This document is a 510(k) summary for a medical device called "Triumph Resin Dam," which is a resin-based, light-cured protective barrier material for dental use. The summary focuses on demonstrating substantial equivalence to a predicate device ("OpalDam") rather than presenting a study proving performance against acceptance criteria in the typical sense of a clinical trial for diagnostic AI.

However, I can extract the relevant information from the document to construct an answer aligned with your request, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence and "study" as the comparison tests performed.

Here's a breakdown of the requested information based on the provided text:

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

For this type of device (a Class I dental resin dam), the "acceptance criteria" are essentially the characteristics and performance deemed equivalent to a legally marketed predicate device. The document primarily focuses on demonstrating substantial equivalence to the Opal Dam (K971284) and referencing BriteSmile (K010935) for hardness comparison.

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Resolve 2.0 is recommended for use on dental restorations, external to the mouth, prior to insertion into the mouth. After applying Resolve 2.0 to cleanse the restoration, the surface of the restoration should be washed thoroughly with water, and then air dried before placement in the mouth. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.

Resolve 2.0 is a thin, non-alcohol based gel containing chlorhexidine gluconate. This thin gel because of its water solubility, abrasive action and low viscosity when applied to dental restorations, acts as a cleaning agent. This gel is provided in easy to use syringes and floc-tipped applicator tips to precisely deliver the gel to the intended areas. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.

It appears the provided document is a 510(k) premarket notification for a dental device named "Resolve 2.0." This type of document is for demonstrating substantial equivalence to a predicate device, not for establishing novel acceptance criteria or conducting a comprehensive clinical study in the way one might for a new drug or a high-risk AI-powered diagnostic device.

Therefore, the requested information categories related to acceptance criteria, detailed study design, sample sizes for test/training sets, expert adjudication, MRMC studies, or specific ground truths for AI models do not directly apply to this document. This submission focuses on demonstrating similarity to an existing, legally marketed device.

However, I can extract the information relevant to the equivalence demonstration as presented in the document:

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

The document doesn't present "acceptance criteria" in the traditional sense of a performance study with defined thresholds. Instead, it compares the technological characteristics of Resolve 2.0 to its predicate device, Consepsis. The "acceptance" is based on demonstrating that these characteristics are equivalent.

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

This information is not applicable/not provided in this type of 510(k) submission. The evaluation is based on physicochemical and biocompatibility testing, not clinical data sets in the AI sense.

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):

This information is not applicable/not provided as there is no "test set" and "ground truth" in the context of an AI device. The evaluation is based on laboratory testing and comparison to the predicate.

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

This information is not applicable/not provided.

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/not provided. This is not an AI-powered device.

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

This information is not applicable/not provided. This is not an algorithm.

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

For the properties evaluated (e.g., pH, water solubility, cleansing activity, biocompatibility), the "ground truth" would be established through laboratory testing and established scientific methods/standards (e.g., pH meter readings, solubility tests, accelerated aging protocols, ISO 10993-5 standard for biocompatibility).

8. The sample size for the training set:

This information is not applicable/not provided. This is not an AI device with a training set.

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

This information is not applicable/not provided.

Summary of the Study:

The document describes a benchtop and biocompatibility study to demonstrate that Resolve 2.0 is substantially equivalent to the predicate device, Consepsis. The study involved:

• Comparison of Technological Characteristics: Resolve 2.0 was compared to Consepsis across several physical and chemical properties including cleansing activity, active ingredient (chlorhexidine gluconate), water solubility, pH, presence of silicate (sand), consistency, pigmentation, and accelerated aging/shelf life.
• Biocompatibility Testing: Resolve 2.0 was evaluated per ISO 10993-5 "Biological Evaluation of Medical Devices" for cytotoxicity. The results were compared to those of Consepsis under the same standard. Both devices exhibited "Moderate" cytotoxicity, showing equivalence.

The conclusion drawn from this "study" (which is more accurately a set of comparative tests) is that Resolve 2.0 is substantially equivalent to Consepsis in design, composition, biocompatibility, performance, aging, limited intended uses, and safety and effectiveness. This equivalence allows the device to be marketed without requiring a full Premarket Approval (PMA) process.

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Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. For Use only by a Licensed Dentist. Rx Use Only.

Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. Denali 501 contains polymerizable monomers that can set in either a light activated mode or set upon mixing Part A and Part B. When set the resin has a low solubility in water to act as a long term cement.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification summary from the FDA for a dental cement called "Denali 501 Cement." It discusses the device's substantial equivalence to predicate devices based on various characteristics, but it does not detail specific acceptance criteria or a study designed to evaluate them in the context of your request.

Therefore, I cannot provide the requested table or the details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

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CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations.

CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations. CERCOM II has the same technological characteristics (intended use, application mechanism) as the predicate device CERCOM, except that CERCOM II is a dual-cure cement. CERCOM II can set on its own as well as set with visible light cure.

This looks like a regulatory approval document (510(k) Summary) for a dental cement, not a study describing the performance of a medical device against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.

The document states that the CERCOM II Cement is "substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate cement products cited." This means it was approved based on its similarity to previously cleared devices, rather than a new standalone clinical trial with specific performance metrics and acceptance criteria.

To answer your request, I would need a document specifically detailing a performance study for a device, including its acceptance criteria and the results of that study.

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AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations.

AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations. This veneer cement is made from a complimentary hydrophilic resin and filler system, which creates compatibility between the tooth surface and restorative materials. AURAVeneer Cement is a unique gel-like product that does not slump and will hold veneers in place without drifting. AURAVeneer is a single component, light cured product. AURAVeneer is provided in clear, enamel/white, and dentin/yellow shades. Corresponding try-in gels of the same colors are also available. It is recommended that enamel surfaces, which are uncut, be etched or micro-abraded to optimize bonding of this product to the dental surface. Etching or the use of bonding agents when bonding to dentin is not required. Equally, the surface of the restoration should also be pretreated to optimize bonding of the restoration. Bonding agents and silage coupling agents are not required for the use of this product.

The provided text is a 510(k) Premarket Notification for AURAVeneer Cement, a dental cement. It does not contain any information about a study with acceptance criteria, sample sizes, expert involvement, or any performance metrics typically associated with AI/ML device evaluations.

The document primarily focuses on establishing "substantial equivalence" of AURAVeneer Cement to existing predicate devices based on design, composition, and intended use, rather than presenting a performance study against specific acceptance criteria. This type of regulatory submission (510(k)) for a dental cement typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of physical and chemical properties, and intended use, rather than through extensive clinical trials with performance metrics.

Therefore, I cannot fulfill your request as the necessary information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.

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AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. AuraLay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. Aural.ay is available in different fluoride concentrations for different patient use.

AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. Aural ay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. AuraLay is available in different fluoride concentrations for different patient use.

The provided text is a 510(k) premarket notification for the "AuraLay Pit & Fissure Sealant." This type of submission is a claim of substantial equivalence to a legally marketed predicate device, rather than a submission that presents de novo clinical study data to demonstrate safety and effectiveness.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, or specific performance metrics from a dedicated clinical study.

Instead, the submission relies on the following:

• Substantial Equivalence: The core of this document is the claim that AuraLay Pit & Fissure Sealant is substantially equivalent in design, composition, performance, intended use, and effectiveness to existing predicate devices (CosmeSeal Pit and Fissure Sealant, UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit, and Delton Clear Pit and Fissure Sealant Kit).
• Predicate Device Performance: The safety and effectiveness are supported by the track record of these predicate devices, which have been found to be substantially equivalent themselves and have been in general usage for about 30 years with a "high benefit-to-risk ratio" and no evidence of short-term or long-term risk.
• NIH Technology Assessment: A reference is made to an NIH Technology Assessment conference regarding "Effects and Side-Effects of Dental Restorative Materials," which states that such materials are "relatively trouble-free" and have "no suspicion of any problems after virtually billions of procedures in the United States."

In summary, there is no direct study described in this document that establishes specific acceptance criteria for the AuraLay Pit & Fissure Sealant and then demonstrates its performance against those criteria using a dedicated test set, ground truth, or statistical analysis (e.g., MRMC or standalone performance). The approval is based on equivalence to already approved and widely used devices.

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Fusion Core is a high strength core material that offers the convenience of light curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resin/filler combination.

Fusion Core is a high strength core material that offers the convenience of fight curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resinffiller combination

The provided text is a 510(k) premarket notification for a dental material called "Fusion Core Material." It asserts substantial equivalence to predicate devices and describes the product's properties and intended use. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

Therefore, I cannot provide accurate information for the requested points. The document focuses on regulatory approval based on substantial equivalence, not on detailed performance studies or statistical evidence.

Specifically, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are defined or reported.
2. Sample sized used for the test set and the data provenance: No test sets or data provenance are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method: Not applicable as no test set evaluation is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The document relies on substantial equivalence to existing dental materials.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a dental material, not a software algorithm.
7. The type of ground truth used: No ground truth for performance is mentioned.
8. The sample size for the training set: No training sets are mentioned.
9. How the ground truth for the training set was established: No training sets or ground truth establishment are mentioned.

The document states: "The Fusion Core Material is substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate kit products listed above." This statement, along with the quote from the NH Technology Assessment conference ("General usage of these materials over about 30 years indicates a high benefit-to-risk ratio... There is no evidence of short-term or long-term risk... There is no suspicion of any problems after virtually billions of procedures in the United States."), serves as the basis for the FDA's substantial equivalence determination, rather than a detailed, de novo study with specific performance metrics and acceptance criteria for this particular device.

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AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel marqins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.

AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel margins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.

The provided text is a 510(k) Premarket Notification for the AuraVue Pit & Fissure Sealant. It outlines the device's description, intended use, and comparison to predicate devices, and concludes with a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document is for a medical device (a pit and fissure sealant for dental use), not an AI/ML-driven diagnostic or medical imaging device. Therefore, the concepts of acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as typically applied to AI/ML device performance, are not relevant or described in this document.

The "study that proves the device meets the acceptance criteria" in this context refers to the demonstration of substantial equivalence to predicate devices, rather than a clinical trial with specific performance metrics against a defined ground truth as would be required for a novel AI/ML device.

Therefore, I cannot provide the requested information in the format specified because it is not contained within the provided document. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies (as there's no "AI" component to compare).
• Standalone algorithm performance (as it's a physical sealant).
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence to existing, legally marketed dental sealants. The safety and effectiveness are established by:

• Comparison of design, composition, and intended use to predicate devices (CosmeSeal Pit and Fissure Sealant, UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit, Delton Clear Pit and Fissure Sealant Kit).
• General usage history of similar materials: The document references a NIH Technology Assessment conference stating that "General usage of these materials over about 30 years indicates a high benefit-to-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States." This statement serves as a broad affirmation of the safety profile of the class of devices.
• Demonstrated clinical success as a sealant: The description mentions "AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant," though specifics of this clinical success are not detailed in the provided text.

The FDA's letter confirms substantial equivalence, which is the regulatory pathway for this type of medical device, essentially meaning it is as safe and effective as a legally marketed predicate device.

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