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Crown, Bridges, Veneer, Onlay & Inlay, Denture, partial denture, Orthodontic appliance, Splints.

• Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
• For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth.

ID LIGHT CURE SYSTEM is a light-curing resin-based coating material for dental use. It is designed to form a film on the resin surface of dental restorations and prosthetic appliances to enhance smoothness and wear resistance. The material is available in 51 shades.

This document is a 510(k) clearance letter for a dental device, the "ID LIGHT CURE SYSTEM." It's important to note that a 510(k) submission primarily demonstrates substantial equivalence to a previously cleared device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Pre-Market Approval).

Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical and biological safety tests performed to demonstrate that the new device performs similarly to the predicate device and does not pose new safety concerns. There is no information in this document about acceptance criteria and performance data for an AI-based or software-driven diagnostic or prognostic device. The product is a physical dental material, a "light-curing resin-based coating material."

Given the nature of the device (a coating material for resin fillings), concepts like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone AI performance," "number of experts for ground truth," or "effect size of human readers with AI assistance" are not applicable. This device is a material, not an AI or imaging diagnostic tool.

However, I will extract the information that is available and clarify what is not applicable based on the provided text for a physical dental material.

Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)

Since this is a physical dental material and not an AI/software device, the "acceptance criteria" are related to its physical and biological properties. The document states that the device "successfully passed all evaluations, demonstrating acceptable physical characteristics and confirming that the product meets its intended technical and performance specifications." This implicitly means the product met its internal acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance

• Indications for Use
• Design
• Material and chemical composition
• Principle of Operation
• Energy source | Indications for Use are stated to be the "same."
  Technical characteristics (Design, Material, Principle of Operation, Energy source) are stated to be the "same."
  Device is "substantially equivalent to the predicate device." |

Study Details (Applicable points only, based on provided text)

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

   • Test Set Sample Size: Not explicitly stated as a number of "samples" in a clinical trial sense. For biological safety, tests were performed according to ISO 10993-1:2018 and ISO 7405:2018, which dictate sample sizes for specific in-vitro and in-vivo tests but these are not enumerated here. For physical properties, "a series of performance tests were conducted," but a specific sample size for each test is not provided.
   • Data Provenance: Not specified. Standardized biological safety tests (ISO standards) are generally conducted in a controlled lab environment. Physical property tests are conducted internally. It is not specified if any data was retrospective or prospective.

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

   • Not Applicable. This is a physical dental material; "ground truth" and "expert adudication" as typically understood for AI diagnostic devices (e.g., radiologists interpreting images) do not apply. Biological safety and physical property tests have objective measurements and pass/fail criteria based on standards.

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

   • Not Applicable. See point 2.

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 a physical dental material, not an AI or imaging diagnostic device.

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

   • Not Applicable. This refers to AI algorithm performance.

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

   • For Biological Safety: Ground truth is established by adherence to international standards (ISO 10993-1:2018 and ISO 7405:2018) and objective biological endpoints (cytotoxicity, irritation, systemic toxicity).
   • For Physical Properties: Ground truth is established by "internal protocols and relevant standards" with objective measurements (appearance, weight, packaging, color stability, sensitivity, depth of cure).
   • No expert consensus, pathology, or outcomes data in the sense of clinical decision-making is relevant here.

7. The sample size for the training set:

   • Not Applicable. This is a physical dental material, "training set" refers to machine learning.

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

   • Not Applicable. See point 7.

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visio.lign color: Characterization with colour effects on the surface of composite restorations, denture base materials and artificial denture teeth.

visio.lign shield: Surface coating and wear resistance of composite restorations, denture base materials and artificial denture teeth.

visio.lign shield & color is a light-curing, transparent or coloured, acrylate-based glossy coating.
visio.lign color achieves colour effects on the surface of composite restorations, denture base materials and artificial denture teeth.
visio.lign color is available in 17 shades.
visio.lign shield provides a surface coating on composite restorations, denture base materials and artificial denture teeth. visio.lign shield is available in the thin-bodied version visio.lign shield LV and in the higher-viscosity version visio.lign shield HV.

The provided text describes a 510(k) premarket notification for dental coating materials (visio.lign color and visio.lign shield). This document focuses on demonstrating substantial equivalence to a predicate device (Optiglaze Color, K133836) through non-clinical bench testing.

Based on the content, the document does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The performance testing mentioned is entirely focused on "Bench testing" for material properties such as bond strength, color stability, surface roughness, and viscosity.

Therefore, many of the requested points related to AI/ML device performance, human reader studies, ground truth establishment, and training/test sets are not applicable to this submission.

Here's a breakdown of what can be answered based on the provided text:

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

The document states: "The design specifications of the subject device were met in the bench testings carried out. This demonstrates that the product fulfills its intended purpose and device description and shows substantial equivalence to the predicate device." However, specific numerical acceptance criteria or reported performance values (e.g., "bond strength was X MPa, meeting criteria of >Y MPa") are not provided in this summary.

The types of tests conducted were:

• Bond strength
• Colour stability
• Surface roughness
• Viscosity

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

• Sample Size: Not specified.
• Data Provenance: The tests are "Bench testing," implying laboratory-based testing of the physical material properties. No country of origin for data or retrospective/prospective nature is mentioned as it's not clinical data.

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

• Not applicable. This submission is for material properties tested via bench studies, not diagnostic performance requiring expert interpretation of images or other clinical data.

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

• Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC study was not conducted. This is a 510(k) for dental coating materials, not an AI/ML diagnostic device for human readers.

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

• Not applicable. This device is a physical dental material, not an algorithm.

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

• The "ground truth" for this device would be the established scientific and engineering standards and methods for testing material properties (e.g., ISO standards for dental materials, internal specifications for bond strength, color stability, etc.). It's based on objective physical measurements, not human interpretation or clinical outcomes in the same way as a diagnostic AI.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. See point 8.

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Characterization of provisionals.

Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
Characterization of C&B composite resin restorations or acrylic resin.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the "RODIN Palette Naturalizing Kit" (K223365) does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily focuses on the regulatory clearance of the device, confirming its substantial equivalence to predicate devices and outlining general regulatory requirements. It specifies the "Indications for Use" but does not delve into the technical study details that would typically be found in a submission's performance section.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided document.

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VITA AKZENT LC Indication range:

• Restorations made of hybrid ceramic
• · Restorations made of light-curing veneering material
• · Restorations made of CAD/CAM composites
• · Prefabricated Teeth
• · Denture bases

VITA AKZENT LC is a light-curing methacrylatebased stain/ glaze system for extraoral surface characterization of dental restorations made of hybrid ceramic, resin veneering materials, CAD/CAM composites, prefabricated teeth and denture base resins. It can also be used for internal characterization with the layering technique of veneering composites.

The document describes the VITA Akzent® LC, a light-curing methacrylate-based stain/glaze system for extraoral surface characterization of dental restorations. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Non-Clinical Performance Testing" and "Biocompatibility" sections.

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 distinct "test set" in the traditional sense of a clinical study with human subjects. The evaluation was primarily based on non-clinical performance testing and biocompatibility assessment.

• For biocompatibility, the testing was conducted in-vitro/non-clinical based on recognized international standards. Specific sample sizes for these tests (e.g., number of specimens tested for cytotoxicity, irritation, etc.) are not explicitly stated in this summary.
• For adhesion performance, "bench testing" was conducted. The sample size for this testing is not explicitly stated.
• The data provenance is not explicitly stated but is presumed to be from laboratory testing as per the cited ISO standards.

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

This information is not applicable and not provided in the document because the assessment was based on non-clinical (laboratory) testing and established international standards for biocompatibility and material performance, rather than clinical efficacy studies requiring expert evaluation of patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided as the evaluation was based on objective laboratory testing against established standards, not human interpretation of results requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of VITA Akzent® AC."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This concept is not applicable to this device. VITA Akzent® LC is a material (a stain/glaze system), not an algorithm or an AI-powered diagnostic tool. Its performance is determined by its physical and chemical properties as evaluated through non-clinical laboratory tests.

7. The Type of Ground Truth Used:

The ground truth for demonstrating the device's performance relies on:

• Established international standards: ISO 10993-1 (Biological evaluation of medical devices) and ISO 7405 (Dentistry – Evaluation of biocompatibility of medical devices).
• Bench test results: Specifically, "adhesion performance testing" against a reference device.
• Material composition equivalence: Comparison of the chemical composition to predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. As VITA Akzent® LC is a material and not an AI/ML algorithm, there is no "training set" in the conventional sense. Its development would likely involve
iterative formulation and testing, but not machine learning training.

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

This information is not applicable and not provided, as there is no "training set" for this type of device. The formulation and development of the material are based on scientific principles of polymer chemistry and dental material science, combined with performance testing.

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Varnish for final coating for resin temporaries to produce a smooth and shiny surface.

Dental sealing lacquer for coating resin temporaries

The light-curing one-component dental sealing lacquers NanoVarnish, Plaquit and Lightpaint on Surface are designed for coating resin parts of complete and partial dental prosthesis and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.

This document is a 510(k) premarket notification for a dental sealing lacquer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI-powered device performance. Therefore, many of the requested criteria regarding AI acceptance, human readers, and ground truth for AI model training cannot be extracted from this document.

Here's what can be extracted based on the provided text:

Acceptance Criteria and Device Performance

For this type of device (a dental material), "acceptance criteria" are based on demonstrating comparable physical and chemical properties to a legally marketed predicate device, rather than accuracy metrics for an AI system. The study performed is a comparative study of the new device against a predicate device.

Table of Acceptance Criteria and Reported Device Performance

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SHOFU RESIN GLAZE is indicated to temporarily glaze the following restoration surfaces:

• Artificial resin teeth
• Acrylic denture base materials
• CAD/CAM PMMA materials
• CAD/CAM hybrid ceramic materials
• Indirect composite resins
• Provisional materials

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding a dental product called "Shofu Resin Glaze". This document does not contain information about acceptance criteria for device performance, the study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given text. This document is a regulatory clearance letter, not a clinical study report or a technical performance evaluation.

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1. For characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth.
2. For obtaining surface smoothness and wear resistance of restorations made of composite. resin, acrylic denture base and artificial acrylic teeth.

Optiglaze Color is a light-cured glazing and for characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth, and also for obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth. The material is available in 17 shades.

The provided text describes the 510(k) premarket notification for "Optiglaze Color," a light-cured glazing and characterizing material for dental restorations. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Here's an analysis of the provided information relative to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical clinical trial report would. Instead, it lists performance bench tests conducted to confirm conformity to specifications. These are implicit acceptance criteria.

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

The document describes bench tests rather than a clinical study with a "test set" of patient data. Therefore, specific sample sizes for a clinical test set are not applicable or provided. The data provenance is laboratory-based testing of the device itself.

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

This information is not applicable. The evaluations mentioned are performance bench tests of the material properties, not interpretations requiring human expert "ground truth" in the diagnostic sense.

4. Adjudication method for the test set

This information is not applicable for bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was conducted or reported. This document pertains to a dental coating material, not an AI software/device that assists human readers.

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

This information is not applicable. The device is a physical dental material, not an algorithm.

7. The type of ground truth used

For the bench tests, the "ground truth" would be established by standardized testing methodologies and specifications for material properties common in dental material science (e.g., ISO standards for depth of cure, hardness measurements, colorimetry for color stability).

8. The sample size for the training set

This information is not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."

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

This information is not applicable.

Summary of the Study and Device Proof:

The submitted information is a 510(k) premarket notification for a dental material. The "study" described is a series of performance bench tests designed to demonstrate that the Optiglaze Color material meets required specifications for a dental glazing and characterizing agent. The core of the submission relies on demonstrating substantial equivalence to existing predicate devices (specifically, G-Coat from GC Corporation).

The document states:

• "It is confirmed that the device conforms to the required specifications and is suitable for its intended use." (Page 2)
• The device complies with all requirements of ISO 10993-1 for biological evaluation.
• The curing mechanism is substantially equivalent to predicate devices, implying similar function, composition, and intended use.

Therefore, the "proof" the device meets acceptance criteria is through successful completion of these internal bench tests (appearance, depth of cure, color stability, surface hardness, application characteristics, packaging, shelf life) and the FDA's determination of substantial equivalence, rather than a clinical trial or algorithm performance study.

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Vita Enamic® Stains are indicated for shade customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials.

The Vita Enamic 6 Stains are color Intensive resins used for shade characterization of the The Vita Enamic restorations made from Vita Enamic The shades are supplied in sonder form. This powder is mixed with a liquid and applied in a very thin layer to an Enamic restoration to adjust the shade or create characteristics found in natural teeth, such as cracks, restoration to of the painted restoration is then sealed with a dear light-curing allaze to create a smooth and glossy finish that is resistant to abrasion. The Stains are a dual curing create a sinopon one phymenzation that is prepared outside the mouth.

This document is a 510(k) summary for "Vita Enamic® Stains". It describes the device and its intended use, and states that it is substantially equivalent to predicate devices. However, it explicitly states there was no clinical performane data or non-clinical performance data done for the device because the device is "for esthetic purposes only". Therefore, none of the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC study, standalone performance, training set details) can be extracted from this document as no such study was conducted or reported.

Specifically, the section "Summary of Non-Clinical Performance Data" on page 1 states: "The intended use of the device is for esthetic purposes only. For this reason, performance Data was not pursued."

Therefore, I cannot provide the requested information.

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Enamelite Acryseal and Enamelite Acryseal-CB Spray Sealant is intended for use as a sealant/bonding agent intended to reline, repair, or rebase denture surfaces and CAD/CAM produced/milled acrylic and composite replacement dental restorations.

Enamelite Acryseal Spray Sealant is a dental sealant or bonding agent which is packaged for aerosol dispensing. The product is formulated as either an acrylic spray sealer or composite spray sealer. The base product is identical to brush on sealants that have been used for over 40 years in the dental profession. The spray on sealant and bonding agent produces the same finished material surface as commonly used brush-on sealants. Enamelite Acryseal Spray sealing and bonding agent produces a much smoother coating compared to a brush-on method and was designed to replace the outdated brush application of sealing/bonding lacquer.

The provided text is a 510(k) summary for the Enamelite Acryseal Spray Sealant and Enamelite Acryseal-CB Spray Sealant. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It's crucial to understand that a 510(k) submission primarily focuses on substantial equivalence and does not typically involve the detailed "acceptance criteria" and "study proving the device meets acceptance criteria" in the same way a novel device might go through a rigorous clinical trial with specific performance metrics.

Instead, the submission argues that the new device has "similar technical features, indications for use, and the safety and effectiveness of the devices is equivalent" to predicate devices. This implies that the 'acceptance criteria' are met indirectly by demonstrating equivalence to devices already accepted by the FDA.

Therefore, the specific information requested in the prompt (acceptance criteria, reported device performance, sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not directly available or applicable within this 510(k) summary.

Here's how to interpret the request in the context of the provided document:

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

• Acceptance Criteria (Implied by Substantial Equivalence): The primary acceptance criterion for a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to one or more predicate devices. This means that the new device is as safe and effective as the predicate, either because it has the same technological characteristics, or if it has different characteristics, these do not raise new questions of safety and effectiveness, and the device is as safe and effective as the predicate.
• Reported Device Performance: The document does not provide specific quantitative performance metrics like sensitivity, specificity, accuracy, or other statistical measures. Instead, it describes the physical and chemical properties and intended function of the device and states that these are equivalent to the predicate devices.
  • Description: "The spray on sealant and bonding agent produces the same finished material surface as commonly used brush-on sealants. Enamelite Acryseal Spray sealing and bonding agent produces a much smoother coating compared to a brush-on method..."
  • Technological Characteristics: Specifies compositions (Methyl Methacrylate Solids and Monomers for Acryseal, 2-Methyl-2-Propenoic Acid and Triethylene Glycol Dimethacrylate for Acryseal-CB, with potential fillers).
  • Functionality: "Product is sprayed onto dental fixtures in very light or thin coats. The dental acrylic sealant begins its chemical bonding process as soon as the material hits the surface of the dental fixture. The acrylic sealant can be air cured in 5 minutes and the composite sealant can be light cured in 90 seconds. Spray sealant facilitates a smooth even layer of material when sprayed onto dental fixtures. Surface porosity and any scratches are sealed and smoothed over to a glossy smooth surface to make cleaning easier and help prevent the growth of harmful bacteria."

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 provided in the 510(k) summary. For a 510(k) based on substantial equivalence to existing devices, extensive new clinical trial data or performance testing with specific "test sets" of data, as might be done for an AI/ML device, is often not required or detailed in the summary if the technological characteristics are sufficiently similar to predicates.

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 provided as there is no mention of a "test set" and associated "ground truth" derived from expert review in the context of this 510(k) submission.

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

• This information is not applicable/provided for the reasons stated above.

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/provided. This device is a dental sealant/bonding agent, not an AI-powered diagnostic or assistive tool for human readers.

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

• This information is not applicable/provided. This device is a physical product (a spray sealant), not an algorithm.

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

• This information is not applicable/provided. The submission is not based on a ground truth derived from clinical data in the traditional sense for evaluating device performance against a gold standard. Instead, it relies on the known or established performance of predicate devices and the chemical/physical properties of the new device relative to those predicates.

8. The sample size for the training set:

• This information is not applicable/provided. This is a physical product, not a software algorithm that would require a "training set."

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

• This information is not applicable/provided.

In summary: The provided 510(k) document is a regulatory submission for a physical dental product (sealant) demonstrating substantial equivalence to pre-existing, legally marketed predicate devices. It does not contain the kind of detailed performance study data, acceptance criteria, sample sizes, or expert ground truth establishment that would be found in a submission for a novel, AI-driven diagnostic device. The "acceptance criteria" here are implicitly met by demonstrating that the device is "as safe and as effective" as its predicate devices, based on similar indications for use, technological characteristics (materials, physical form, application), and anticipated performance.

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EASY GLAZE is intended for the following applications:

1. Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations.
2. Sealing the adhesive interfaces between restoration and tooth structure.
3. Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement.
4. Sealing glass ionomer cement liners/build-up restorations before taking impressions.

EASY GLAZE is a nanofilled, light-curing coating with natural fluorescence for sealing surfaces. The coated surface is luminous, provides protection against discolouration and yields a natural appearance. EASY GLAZE can be polymerised with all light-curing dental devices.

The provided text is a 510(k) Summary for a dental device called "EASY GLAZE". This document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving the device meets them.

Here's a breakdown of why the requested information isn't fully available and what can be inferred:

The core argument for the "EASY GLAZE" device is that all of its components are found in legally marketed predicate devices. This approach (often called "component-based substantial equivalence") implies that if the components are safe and effective in other approved devices, the new device using those same components will also be safe and effective for its stated intended use.

Therefore, many of the requested criteria related to a dedicated performance study with specific acceptance criteria, sample sizes, expert ground truth, etc., are not present in this type of 510(k) submission.

Here's an attempt to answer your questions based on the provided text, highlighting what is not applicable or not disclosed:

Acceptance Criteria and Study for EASY GLAZE

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance tests. The implicit acceptance criterion is "substantial equivalence" to the predicate devices.
• Reported Device Performance: The primary "performance" reported is the assertion that "The prior use of all of the components of EASY GI.AZE in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary." This indicates that the performance is benchmarked against the established performance of its components in predicate devices. No specific quantitative performance metrics (e.g., bond strength, wear resistance) are provided for EASY GLAZE itself in this summary.

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

• Sample Size: Not applicable/not disclosed. No dedicated "test set" for a performance study of the final EASY GLAZE formulation is mentioned because the argument relies on component equivalence.
• Data Provenance: Not applicable. The "data" used is the regulatory history and prior approval of the components in other devices.

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

• Number of Experts: Not applicable/not disclosed. Ground truth establishment for a new performance study is not described.

4. Adjudication method for the test set:

• Adjudication Method: 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:

• MRMC Study: Not applicable. This device is a dental coating, not an AI diagnostic tool involving human readers.

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

• Standalone Performance: Not applicable. This is not an algorithm.

7. The type of ground truth used:

• Ground Truth: For the purpose of this 510(k), the "ground truth" implicitly relies on the established safety and effectiveness of the individual components of EASY GLAZE, as demonstrated by their prior approval in the predicate devices (K052462, K043168, K974772, K070306). There is no "ground truth" derived from a new, independent study of EASY GLAZE's performance explicitly mentioned.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not a machine learning/AI device, so there is no training set in the typical sense.

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

• Ground Truth for Training Set: Not applicable.

Summary of Approach:

This 510(k) summary uses the "substantially equivalent" pathway by arguing that EASY GLAZE is composed entirely of components already found in other legally marketed devices. Therefore, the burden of requiring new, extensive performance studies (which would have specific acceptance criteria, sample sizes, ground truth establishment, etc.) directly on the EASY GLAZE product is reduced. The "study" referenced is essentially the regulatory history and established safety/effectiveness profiles of the individual components and the predicate devices themselves.

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