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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and bonding agent produces a much smoother coating compared to a brush-on method and was designed to replace the outdated brush application of sealing/bonding lacquer.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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The Enamelite Porcelain Powders are aerosol devices intended to be used as spray applications of ceramic porcelains and glazes for dental restorations (crowns and bridges), which are produced in dental laboratories.

Ceramic Finishing Glaze (Nova Ceramic Spray Glaze). The Enamelite Nova Ceramic Spray Glaze is essentially identical to that used in the Leach and Dillon Shake n Spray powders. It is made of glass frit and is applied to dental restorations in an aerosolized uncontaminated form. Like all other porcelain powders, the Nova Ceramic Spray Glaze is only applied on dental restorations in dental laboratories. As with the parent Leach and Dillon device, the Nova Ceramic Spray Glaze in an aerosol form decreases the in-process time of hand applied glazing methods while providing a substantially more even coating of glaze. Both the parent and modified devices allow the dental technician to apply glaze on either single or multiple units at one time. The Nova Ceramic Spray Glaze is used to construct restorations that fire at temperatures from 650° C to 930° C. Various types of porcelains that are compatible with Nova Glaze include porcelain-fused-to metal, pressed ceramic restorations and milled zircon restorations. The Nova Glaze enables the dental technician the ability to spray a glaze over unfired dental ceramic stains and over unfired add-on porcelains which some restorations may require to esthetically match the dental patient's natural teeth. This flexibility will make these adjustments more efficient for the technician saving multiple firings staining, shading and repairing restorations.

Opaque Porcelain (Tru-Paque) The Tru-Paque opaque porcelain powder is a ceramic opaque spray porcelain intended to mask metal sub-structures. This provides a base layer for bonding additional translucent body porcelain layers of "Porcelain-Fused-to-Metal" (PFM) dental restorations. The purpose of opaque porcelains is to mask the dark color of metal sub-structures called "copings" used in porcelain-fused-to-metal constructed dental restorations, and to provide a layer to which translucent body porcelains are bonded. The Enamelite Tru-Paque is offered in an uncontaminated aerosolized form. As with the parent Leach and Dillon devices, the Tru-Paque opaque porcelain is applied on dental restorations in dental laboratories.

The provided text is a 510(k) summary for a medical device called "Nova Ceramic Spray Glaze and Tru-Paque Opaque Porcelain." This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. It is not a study report that details acceptance criteria and device performance in the way a clinical trial or a validation study for a diagnostic algorithm would.

Therefore, many of the requested elements of your prompt, such as acceptance criteria, reported device performance metrics (like sensitivity, specificity, AUC), sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment methods for training or test sets, are not applicable or not present in this type of regulatory submission.

This document focuses on demonstrating that the new device is "substantially equivalent" to an already legally marketed predicate device (Leach and Dillon Shake and Spray Porcelain Powders - K895889). The primary method used here is comparing technological characteristics rather than extensive performance studies with statistically derived acceptance criteria.

However, I can extract the information that is present:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way a diagnostic device would. Instead, it states:

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

• Sample Size for Test Set: Not specified. The document mentions "Verification and Validation testing" but does not detail the size or nature of the test sets used.
• Data Provenance: Not specified. No information on country of origin or whether testing was retrospective/prospective.

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 specified. This type of submission does not involve expert-established ground truth for performance metrics in the context of diagnostic accuracy.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/not specified.

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: No, this is not an AI-based diagnostic device. It is a dental material/delivery system.
• Effect Size: Not applicable.

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

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

7. The type of ground truth used

• Type of Ground Truth: Not applicable in the traditional sense of diagnostic accuracy. The "ground truth" for this device would be its physical and chemical properties, its ability to adhere, its aesthetic outcome, and its compatibility with dental restorations, verified through laboratory/bench testing rather than clinical expert consensus or pathology reports.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that uses a "training set."

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

• Ground Truth for Training Set: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states that "Verification and Validation testing of the Enamelite devices was successfully performed and demonstrates that the modified devices function as intended." This is a general statement typical of 510(k) submissions for devices like this. The core of the "proof" for substantial equivalence lies in the comparison of technological characteristics between the proposed device and the predicate device, as outlined in section 6 of the submission. The key arguments are:

• Similar Mechanism: Both use aerosol spray delivery systems for porcelain powders.
• Consistent Application: Both systems provide consistent and controllable applications.
• Improved Feature: The only significant difference (reduced particle size) is presented as an improvement leading to "thinner more uniform coating resulting in more life-like dental restorations" and decreased in-process time.

The FDA's finding of substantial equivalence (as indicated in the letter from Susan Runner, DDS, MA) confirms that based on the provided information, the device is considered as safe and effective as a legally marketed predicate device. This is primarily a regulatory determination based on technological comparison and general validation rather than a detailed performance study with explicit statistical acceptance criteria for diagnostic accuracy.

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