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Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Profisil® Fluoride Varnish is designed to securely adhere to the tooth surface for several hours while releasing fluoride ions. The varnish contains 5 % sodium fluoride suspended in a mucosa-friendly, pleasantly flavored dimethicone gel. The varnish is available in following versions: mint, berry and unflavored.

The provided document describes a 510(k) premarket notification for a dental device, "Profisil Fluoride Varnish." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for effectiveness. Therefore, the information typically requested about acceptance criteria and studies proving a device meets them for new effectiveness claims, especially those involving AI or comparative effectiveness with human readers, is not directly applicable to this specific submission.

However, the document does detail how the new device demonstrates equivalence to its predicate, focusing on non-clinical performance and biocompatibility. Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

For "Profisil® Fluoride Varnish," the acceptance criteria for non-clinical performance are based on the international standard EN ISO 17730:2020 "Dentistry - fluoride varnishes."

Biocompatibility Acceptance Criteria:

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

• Test set sample size: Not explicitly stated as this is a non-clinical device evaluation. The "test set" would refer to the samples of the Profisil® Fluoride Varnish subjected to the various physical and chemical tests (e.g., specific batches for pH, viscosity, fluoride release tests) and biocompatibility studies (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation). The exact number of samples tested for each property is not detailed in the summary.
• Data provenance: The standard EN ISO 17730:2020 is an international standard. Biocompatibility standards like ISO 10993 series are also international. The summary indicates these tests were performed to demonstrate compliance with these standards, suggesting laboratory testing specifically for the Profisil® product. There is no information on country of origin of data beyond the manufacturer being based in Germany. The data is prospective as it was generated to support the current submission.

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

This information is not applicable. The "ground truth" for this type of device comparison is based on established scientific and engineering principles codified in international standards (EN ISO 17730:2020 for dental fluoride varnishes) and biocompatibility standards (ISO 10993 series). The results are objectively measured physical and chemical properties and biological responses, not subjective interpretations by human experts in the sense of medical image analysis.

4. Adjudication Method for the Test Set

Not applicable, as the "test set" involves objective laboratory measurements against predefined standard requirements rather than subjective assessments requiring adjudication.

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 fluoride varnish, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant to this submission.

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

Not applicable for the same reason as above; this is a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the current device's performance evaluation is based on International Standards:

• EN ISO 17730:2020 "Dentistry - fluoride varnishes" for physical and chemical properties (pH, dynamic viscosity, fluoride release, SEM).
• ISO 10993 series for biocompatibility studies (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity).

These standards define the acceptable range or nature of results for these properties, which serve as the objective "ground truth" for evaluation.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

Not applicable.

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Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.

Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post-operative sensitivity. 1mL of varnish contains 50 mg of sodium fluoride, equivalent to 22.6 mg fluoride ion. Varnish is sweetened with sucralose and Xylitol, and flavored. Varnish and applicator are packaged together in a molded opaque acclar tray, and sealed with a metallized foil.

Here's an analysis based on the provided document, addressing your questions about acceptance criteria and the supporting study:

The provided document (K153334) is a 510(k) premarket notification for the Oral-B 5% Sodium Fluoride Varnish. It's important to understand that this document describes a submission seeking substantial equivalence to a predicate device, not necessarily a study proving a device meets specific pre-defined acceptance criteria for efficacy or safety in a new, standalone clinical trial. The focus here is on demonstrating that the new device is as safe and effective as an already legally marketed predicate device.

Therefore, many of your questions, particularly those related to a clinical study with detailed performance metrics, ground truth establishment, expert adjudication, or MRMC studies, are not applicable to the information presented in this 510(k) summary.

However, I can extract the relevant information regarding performance data and the comparison to the predicate device.

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

Since this is a 510(k) submission seeking substantial equivalence to a predicate, the "acceptance criteria" are generally that the new device performs as expected and is comparable to the predicate device in relevant quantifiable aspects, and is safe and effective for its intended use. Specific quantitative performance "acceptance criteria" and direct numerical "reported device performance" are not explicitly listed in the format you might see for a de novo or PMA submission. Instead, the document focuses on demonstrating comparability.

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

The document mentions "Performance - Comparative bench testing with the predicate was carried out by independent laboratories." However, it does not specify the sample size for these bench tests.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "independent laboratories" performed the testing.

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

This information is not provided in the 510(k) summary. For bench testing related to fluoride release and tubule occlusion, the "ground truth" would be established by the measurement methods themselves, adhering to scientific standards, rather than expert interpretation of results in the way ground truth is established for diagnostic devices (e.g., by radiologists).

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially for diagnostic outputs where multiple experts interpret data. The tests described here are bench tests for physical/chemical properties.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done and is not mentioned. The document states, "Clinical data were not needed for these devices to show substantial equivalence."

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

This question is not applicable. The device is a physical product (fluoride varnish), not a software algorithm.

7. The type of ground truth used

For the nonclinical performance data mentioned:

• Fluoride Release and Dentin Tubule Occlusion: The "ground truth" is derived from objective laboratory measurements based on established scientific protocols and methods. This is not "expert consensus," "pathology," or "outcomes data" in the usual sense.
• Biocompatibility: The "ground truth" is established by adherence to international standards (ISO 10993-5 and ISO 10993-10) and the specific biological responses observed in the tests.

8. The sample size for the training set

This is not applicable/not provided. The device is a physical product, and the testing described does not involve a "training set" in the context of machine learning or AI algorithms.

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

This is not applicable, as there is no training set for this type of device and submission.

Summary of the Study:

The "study" described in the 510(k) summary is primarily a non-clinical bench testing comparison of the Oral-B 5% Sodium Fluoride Varnish against a legally marketed predicate device (VarnishAmerica 5% Sodium Fluoride Varnish).

• Objective: To demonstrate substantial equivalence of the new device to the predicate device.
• Methods: Comparative bench testing was performed by independent laboratories for:
  • Fluoride release
  • Dentin tubule occlusion
  • Biocompatibility (cytotoxicity, irritation, sensitization) per ISO 10993 standards.
  • Shelf-life determination.
• Findings: The Oral-B varnish's fluoride release and tubule occlusion characteristics were found to be "as expected and comparable to the predicate." Biocompatibility testing yielded "equivalent results" for cytotoxicity and provided "evidence of biocompatibility" for irritation and sensitization. A 24-month shelf life was established.
• Conclusion: The non-clinical performance data, along with composition and indications for use, established that Oral-B varnish is substantially equivalent to the predicate device. Clinical data were deemed unnecessary for this demonstration.

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Vella® 5% Sodium Fluoride Varnish with NuFluor® and Xylitol® is a topical fluoride varnish for the treatment of dentin hypersensitivity.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental device called "Vella 5% Sodium Fluoride Varnish with NuFluor® and Xylitol®." This document primarily grants clearance for the device based on substantial equivalence to predicate devices and outlines regulatory requirements.

Crucially, the document does NOT contain information about acceptance criteria, device performance studies, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The letter focuses on regulatory approval based on equivalent indications for use, stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document does not contain this type of clinical or performance study information.

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ProFluoro™ Fluoride Varnish is intended for use as:

• Professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film

ProFluoro™ Fluoride Varnish is a resin-based 5% sodium fluoride varnish applied to tooth surfaces with an applicator brush. Moisture from saliva cures the varnish and leaves a film on tooth to treat tooth hypersensitivity.

This document describes a 510(k) premarket notification for "ProFluoro™ Fluoride Varnish" by Pac-Dent International, Inc. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.

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

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

• Sample Size: Not explicitly stated for each specific physical test (appearance, total fluoride, pH, film thickness). The document refers to "bench testing" without providing specific sample numbers for each measurement.
• Data Provenance: The study was conducted as "bench testing," meaning it was performed in a laboratory setting. The country of origin for the data is not specified, but the applicant (Pac-Dent International, Inc.) is based in Walnut, CA, USA, suggesting the testing was likely conducted in the USA or supervised by the US-based company. The study is retrospective in the sense that it evaluates the performance of the new device against an existing predicate.

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 to this type of submission. The "ground truth" for the physical and chemical properties of a fluoride varnish is based on established scientific and engineering principles and objective measurements, not expert consensus in the diagnostic sense. The comparison is against quantifiable properties of a predicate device.

4. Adjudication method for the test set:

Not applicable. This study focuses on objective physical and chemical property comparisons rather than subjective human assessments requiring adjudication.

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 submission concerns a fluoride varnish, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-assistance evaluation was performed.

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

Not applicable. This submission concerns a fluoride varnish, not an algorithm or AI device.

7. The type of ground truth used:

The ground truth for the physical tests (appearance, total fluoride, pH, film thickness) was the measured performance of the legally marketed predicate device, Enamelast™ Fluoride Varnish, combined with established scientific standards for such dental materials. For biocompatibility, the ground truth was the established safety record of the chemical components when used in predicate devices and the results of a risk analysis.

8. The sample size for the training set:

Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

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

Not applicable. See point 8.

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StarBright™ 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.

StarBright™ 5% Sodium Fluoride Varnish is a rosin based 5% sodium fluoride varnish. This device is available in tray form unit doses of 0.25 and 0.40 mL. Fluoride ions within StarBright™ 5% Sodium Fluoride Varnish may react with calcium and phosphate ions in saliva to form crystals in exposed dentin tubules, such as in exposed root surfaces, leading to protection by blocking external stimuli thereby reducing hypersensitivity.

The provided document is a 510(k) premarket notification for a medical device called "StarBright™ 5% Sodium Fluoride Varnish." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on its performance against quantitative metrics in a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria tables, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or detailed ground truth types.

Here's why the information is not present and what the document does contain:

• Type of Device: The device is a "Cavity Varnish" (Product Code: LBH), regulated as Class II. This is a dental material, not an AI/ML-based diagnostic or imaging device.
• Regulatory Pathway (510(k)): The 510(k) pathway for medical devices largely relies on showing that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics, intended use, and performance, often through bench testing and biocompatibility. It does not generally require large-scale clinical trials or detailed performance metrics against ground truth, especially for a well-established device type like a fluoride varnish.
• Lack of AI/ML Component: The device is a chemical preparation. It does not involve any artificial intelligence, machine learning, image analysis, or diagnostic algorithms. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication," "MRMC study," and "standalone algorithm performance" are not applicable to this product.

What the document does include relevant to its regulatory pathway:

• Identified Predicate Devices: The submission identifies several predicate devices (e.g., Duraflor ®, 3M Vanish, Nupro Model 13016901, Enamelast) to which StarBright™ 5% Sodium Fluoride Varnish is considered substantially equivalent.
• Technological Characteristics and Intended Use: It states that the device has the same intended use (cavity varnish, treatment of dentin hypersensitivity) and similar technological characteristics (rosin-based 5% sodium fluoride varnish, paste formulation, unit dose packaging, applied with a brush) as the predicate devices.
• Non-clinical Performance Testing: It mentions that non-clinical performance testing (fluoride release, tubule occlusion, cytotoxicity, sensitization, irritation) was conducted to support substantial equivalence. The document states these tests "demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices." This is the closest it comes to performance, but it's not quantitative "acceptance criteria" on a diagnostic metric.
• No Clinical Performance Testing: The document explicitly states, "Clinical performance data was not included." This further supports that the type of study design you're asking about (which often involves clinical endpoints or diagnostic accuracy) was not a requirement for this specific 510(k) submission.

In summary, as the input document describes a chemical dental product undergoing a 510(k) review based on substantial equivalence, the requested information pertaining to AI/ML device performance and clinical studies (e.g., MRMC, standalone algorithm performance, expert ground truth) is not applicable or present in this document.

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Pulpdent Fluoride Varnish is a resin-based 5% sodium fluoride varnish, formulated without volatile solvents, that is applied to enamel or dentin and is used for professional treatment of dental hypersensitivity by occluding dentinal tubules and by promoting an environment conducive to remineralization.

Pulpdent Fluoride Varnish is a resin-based 5% sodium fluoride varnish, formulated without volatile solvents, that is applied to enamel or dentin and is used for professional treatment of dental hypersensitivity by occluding dentinal tubules and by promoting an environment conducive to remineralization.

This 510(k) premarket notification for Pulpdent Fluoride Varnish does not contain a study that establishes acceptance criteria and then demonstrates the device meets those criteria through performance testing.

Instead, the submission relies on the concept of substantial equivalence to predicate devices that have been on the market for an extended period with a history of safe and effective use.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable to this specific submission.

Here's an breakdown of the available information based on your request, highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable.

This submission does not define specific acceptance criteria (e.g., a required percentage reduction in hypersensitivity, or a specific level of remineralization) for Pulpdent Fluoride Varnish, nor does it present device performance data against such criteria.

The basis for regulatory clearance is "substantial equivalence" to predicate devices, implying that its performance is expected to be similar to devices already found safe and effective. The submission states: "Pulpdent Fluoride Varnish is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above."

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

Not Applicable.

No specific test set or associated sample size is described for this device's performance evaluation. The safety and effectiveness claim is based on the long-term market history of the predicate devices.

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

Not Applicable.

No specific ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

Not Applicable.

No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not Applicable.

No MRMC comparative effectiveness study was performed or referenced for this device. The device is a physical product (fluoride varnish), not an AI or imaging diagnostic tool where such studies are typically relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable.

This is a physical medical device (fluoride varnish), not an algorithm or software. Standalone performance as typically understood in AI/software evaluations is not relevant here.

7. The Type of Ground Truth Used

Indirect Ground Truth: Clinical history of predicate devices.

The "ground truth" for the claim of safety and effectiveness is the established safety and effectiveness profile of the predicate devices, which have been "on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems." This relies on real-world clinical outcomes over an extended period.

8. The Sample Size for the Training Set

Not Applicable.

No "training set" in the context of algorithm development is relevant to this physical device.

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

Not Applicable.

No training set or associated ground truth establishment is relevant to this physical device.

Summary of the K093620 Submission Strategy:

The manufacturer, Pulpdent Corporation, opted for a 510(k) Premarket Notification based on substantial equivalence. This pathway allows devices to be cleared for market if they are shown to be as safe and effective as a legally marketed predicate device. In this case, the safety and effectiveness of Pulpdent Fluoride Varnish is primarily supported by:

• Comparison to Predicate Products: Pulpdent Fluoride Varnish is stated to be "substantially equivalent in design, composition, performance, intended use, safety and effectiveness" to several fluoride varnishes already on the market (e.g., Scientific Pharmaceuticals Sci-Pharm Desensitizing Varnish, Ultradent Flor-Opal Varnish White, 3M Vanish 5% NaF White Varnish, Colgate Duraphat).
• Long-term Market History of Predicates: The predicate products have a history of "more than 15 years" of successful use by dental professionals "with no serious safety or effectiveness problems."
• Compositional Similarity: The device is formulated with materials "that have been used in the dental industry for many years without incident."
• Literature References: A list of 16 scientific articles related to the safety and effectiveness of fluoride varnishes in general is provided, further supporting the understanding of the class of devices. These references likely contribute to the general understanding of fluoride varnish efficacy in treating dental hypersensitivity and promoting remineralization, implicitly supporting the claim for the new device as well.

This approach bypasses the need for new clinical trials or detailed performance studies for the specific device if substantial equivalence can be adequately demonstrated.

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Vanish Varnish is for use on sensitive teeth, over exposed dentin and root surface sensitivity and under temporary restoratives and cements where post-operative sensitivity is of concern.

Vanish™ Varnish, 5% Sodium Fluoride Varnish is classified as Cavity Varnish (21 C.F.R§872.3260) because it is a device that provides relief from tooth surface hypersensitivity when applied to enamel and dentin surfaces by forming a film that facilitates occlusion of compromised surfaces including open dentinal tubules.

Vanish Varnish is a topically applied. flavored cavity varnish containing sodium fluoride in a rosin based preparation. The varnish is an insoluble viscous liguid that forms a film on tooth surfaces. This dispensing system provides simultaneous dispensing of each component for a consistent mix.

The chemical composition is identical to predicate fluoride containing rosin based cavity varnish devices that have been in use for decades. 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 product is equivalent to current varnishes in properties. intended use and composition. Results provided in the submission confirm the equivalent to the predicate devices with common indications.

The provided text is insufficient to answer the request. The document describes a 510(k) summary for a dental product (Vanish Varnish), outlining its classification, predicate devices, description, and indications for use. It primarily focuses on demonstrating substantial equivalence to existing devices.

However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document confirms that the chemical composition and properties are "equivalent to current varnishes" and "confirm the equivalent to the predicate devices with common indications," but it does not present the specific data or studies that prove this equivalence in the format requested.

Therefore, I cannot extract the requested information from the provided text.

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Intended for: 1) treatment of hypersensitive teeth: 2) sealing the dentinal tubu es for cavity preparations or on sensitive root surfaces; and 3) a cavity liner.

FLUORIDE VARNISH coats a prepared tooth surface prior to placement of any restorative materials to prevent any of the restorative materials from pene rating into the dentinal tissue. FLUORIDE VARNISH contains releasable fluoride.

FLUORIDE VARNISH will be offered in unit dose vials with applicator brushes. Each vial contins material to treat 4-8 teeth, depending on their size.

This document is a 510(k) Summary for a medical device called "FLUORIDE VARNISH." It is a regulatory filing with the FDA, primarily focused on establishing substantial equivalence to previously marketed devices.

Based on the provided document, the device described is a Fluoride Varnish intended for dental use. The document focuses on regulatory approval based on substantial equivalence, not a study proving specific performance metrics against pre-defined acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested elements (acceptance criteria, device performance table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. This document aims to demonstrate that the new device is as safe and effective as existing legally marketed predicate devices, primarily through its components, intended use, and biocompatibility, not through a clinical performance study with quantitative acceptance criteria for predictive accuracy.

Here's an analysis of the available information:

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

Not applicable/Not present. This document is a 510(k) summary for a dental varnish, establishing substantial equivalence based on composition and intended use, not on quantitative performance metrics requiring specific acceptance criteria like an AI/ML diagnostic device.

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

Not applicable/Not present. This document does not describe a clinical performance study with a test set in the context of device performance metrics. Instead, it references biocompatibility testing and the prior use of components in legally marketed devices.

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/Not present. This is not a diagnostic device requiring expert-established ground truth for performance evaluation.

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

Not applicable/Not present.

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/Not present. This document does not describe an AI/ML device or a comparative effectiveness study involving human readers.

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

Not applicable/Not present. This is not an algorithm-based device.

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

The concept of "ground truth" as typically applied to diagnostic performance studies is not directly relevant here. The "truth" in this context refers to the safety and effectiveness of the device based on its components, manufacturing, and intended use being comparable to predicate devices. The document states:

• "All of the components found in FLUORIDE VARNISH have been used in legally marketed devices or were found safe for dental use."
• "FLUORIDE VARNISH has been evaluated and passed biocompatibility testing for cytotoxicity, acute oral toxicity, irritation, and sensitization."

This suggests that the "ground truth" for proving safety and effectiveness relies on:

• Historical data and prior regulatory approvals of the individual components.
• Biocompatibility testing results (which serve as the "ground truth" for the device's biological safety).

8. The sample size for the training set

Not applicable/Not present. This is not an AI/ML device requiring a training set.

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

Not applicable/Not present.

Summary of Device and Approval Process from the Document:

• Device Name: FLUORIDE VARNISH
• Manufacturer: DENTSPLY International
• Intended Use:
  1. Treatment of hypersensitive teeth
  2. Sealing the dentinal tubules for cavity preparations or on sensitive root surfaces
  3. A cavity liner
• Predicate Devices: Duraphat Fluoride Varnish (K945794) and Duragard Fluoride Varnish (K002581)
• Approval Basis: Substantial equivalence to predicate devices, based on:
  • Shared components with legally marketed devices.
  • Biocompatibility testing (cytotoxicity, acute oral toxicity, irritation, sensitization).
  • Performance data (though not detailed as quantitative metrics in this summary).
• Regulatory Decision: FDA determined the device is substantially equivalent to legally marketed predicate devices.

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