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Rennou™ Varnish is indicated for the relief of tooth hypersensitivity through the mechanical occlusion of dentinal tubules.

Rennou™ Varnish is a cavity varnish intended for professional use as a topical application on prepared tooth surfaces. This fluoride-free varnish creates a rosin-based film that prevents penetration of restorative material into the dentinal tissue and provides relief of tooth hypersensitivity by occluding open dentinal tubules. Unit-dose varnish and applicator are packaged together in individual thin, sealed trays. Rennou™ Varnish is only applied by a professional clinician.

Rennou™ Varnish is a topically applied flavored (Spearmint, etc.) compound comprised of natural rosin, ethanol, xylitol, and Rennou™ (a combination of theobromine, calcium acetate, and sodium hydrogen phosphate). The major components are rosin and ethanol, which, when delivered together, efficiently promote a fast-drying film on the tooth surface. The varnish is sweetened with xylitol.

The provided document is an FDA 510(k) clearance letter for Rennou™ Varnish. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria in a quantitative manner typical of an AI/software device.

A 510(k) submission primarily shows that a new device is as safe and effective as a legally marketed predicate device. While "testing summary" is mentioned, it refers to laboratory studies, not a clinical trial with human subjects and specific performance metrics like sensitivity, specificity, or accuracy compared to ground truth.

Therefore, many of the requested elements for an AI/software device performance study are not applicable or cannot be extracted from this document, as Rennou™ Varnish is a physical medical device (cavity varnish), not an AI/software device.

Here's an analysis based on the information provided, highlighting the differences:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in the way an AI/software device would (e.g., minimum sensitivity of 90%). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device in terms of:

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. The "tests" mentioned are general laboratory studies ("Comprehensive laboratory studies evaluated Rennou™ Varnish for performance and biocompatibility. Enamel protection and dentinal hypersensitivity tests on molars and dentin specimens..."). There is no mention of a "test set" in the context of an AI/software device's performance evaluation against a defined ground truth.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a physical product, not an AI/software diagnostic or assistive tool where expert-established ground truth is typically used for performance evaluation.

4. Adjudication Method

Not applicable for a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/software device designed to assist human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical product, not an algorithm. The laboratory studies focused on the physical properties and biological interactions of the varnish itself.

7. Type of Ground Truth Used

For the laboratory studies:

• Physical/Biological Measurements: SEM analysis for tubule occlusion, deep penetration, smooth surface finish.
• Biocompatibility Standards: ISO 10993-5 and USP for cytotoxicity.
  These are objective measurements and established standards, rather than "ground truth" derived from expert consensus or pathology in the context of diagnostic AI.

8. Sample Size for Training Set

Not applicable for a physical medical device. There is no "training set" in the context of machine learning.

9. How Ground Truth for Training Set Was Established

Not applicable.

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Treatment of dentinal hypersensitivity. For use in adults over the age of 21.

Riva Star is a two-component device made up of Riva Star Step 1, containing silver diamine fluoride liquid, and Riva Star Step 2, containing aqueous potassium iodide liquid. Riva Star Step 1 silver diamine fluoride solution is applied to the tooth, immediately followed by Riva Star Step 2 aqueous potassium iodide, which forms an immediate reaction precipitate of silver iodide, thereby reducing tooth sensitivity by physically occluding the open dentinal tubules. Riva Star as well as predicates are liquids or gels that are applied to the teeth using an applicator brush or similar application.

The provided text describes the performance and equivalency of the device "Riva Star" to predicate devices, primarily "Advantage Arrest" and "Super Seal," for the treatment of dentinal hypersensitivity. However, the text does not contain a formal table of "acceptance criteria" and subsequent "reported device performance" against those criteria in a structured format. Instead, it discusses comparability to predicate devices and results from various tests, which indirectly serve as evidence of the device's acceptable performance.

Based on the information provided, here's a structured response outlining the key aspects:

1. Table of Acceptance Criteria and Reported Device Performance

As there is no explicit table of quantitative acceptance criteria provided in the text, I will infer what appears to be the implicit acceptance criteria from the non-clinical and clinical performance testing sections and present the reported performance of Riva Star against those objectives. The primary objective is substantial equivalence to predicate devices.

• Ion Release: Riva Star released less fluoride and silver ions compared to primary predicate Advantage Arrest in a 7-day in vitro study, "demonstrating that Riva Star is as safe as Advantage Arrest."
• Biocompatibility: Passed Cytotoxicity (ISO Agarose, ISO Direct contact), Sensitisation (ISO Guinea Pig Maximization Sensitization), Oral Mucosal Irritation (Hamsters, collar method, 7 day), and Oral Acute Toxicity (Mice - 7 day) tests, providing "evidence of biocompatibility." Cytotoxicity results were "equivalent" to Advantage Arrest. |
  | 6. Shelf Life | Met: Stability testing established a shelf life of "25 months when stored between 2ºC (35ºF) to 8ºC (45ºF)." |
  | 7. Clinical Effectiveness in Reducing Dentinal Hypersensitivity | Met: A double-blind randomized clinical trial showed that "Riva Star was more effective than Super Seal in reducing dentine hypersensitivity after 7 days." This demonstrates clinical effectiveness, furthering the case for substantial equivalence. |

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

• Non-Clinical Hydraulic Conductance Study: Not explicitly stated how many dentin samples were used.
• Non-Clinical In Vitro Ion Release Study: Not explicitly stated how many samples of Riva Star and Advantage Arrest were tested.
• Biocompatibility Studies (Animals):
  • Sensitization: Guinea Pigs (sample size not specified)
  • Oral Mucosal Irritation: Hamsters (sample size not specified)
  • Oral Acute Toxicity: Mice (sample size not specified)
• Clinical Performance Testing:
  • Sample Size: Patients with "recognisable tooth sensitivity on both sides of their upper arch" (Exact number of patients/teeth not specified, but implied to be sufficient for a randomized clinical trial).
  • Data Provenance: The study was a "double blind randomised clinical trial on patients." The country of origin is not explicitly stated in the provided text.
  • Retrospective or Prospective: Prospective (clinical trial).

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

• Clinical Performance Testing: Ground truth (reduction in dentinal hypersensitivity) was established by patient responses recorded on a Visual Analogue Scale (VAS). This indicates self-reported patient pain levels, not expert consensus as the primary ground truth.
• Non-Clinical Studies: Ground truth for hydraulic conductance, SEM imaging, ion release, and biocompatibility was established through objective laboratory measurements and biological assays, not expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

• Clinical Performance Testing: The primary "ground truth" was patient-reported pain levels via Visual Analogue Scale (VAS). This is a self-adjudication method. The trial was "double blind randomized," suggesting measures were taken to prevent bias in data collection and interpretation. No external expert adjudication method (e.g., 2+1, 3+1) is mentioned for the clinical trial.
• Non-Clinical Studies: No adjudication method as these involved objective laboratory measurements.

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 comparative effectiveness study involving human readers or AI assistance was not mentioned. The device, Riva Star, is a dental product (tooth desensitizer), not an imaging or diagnostic AI-powered device that would typically undergo such a study design.

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

• Not applicable. Riva Star is a physical product (liquid solution) applied by a clinician, not an algorithm.

7. The Type of Ground Truth Used

• Non-Clinical Studies (Hydraulic Conductance, SEM, Ion Release, Stability): Objective laboratory measurements and observations (e.g., fluid flow rate, microscopic images showing precipitate formation, ion concentrations, physical property measurements).
• Biocompatibility Studies: Biological assay results (e.g., cell viability, observed irritation/sensitization responses in animal models).
• Clinical Performance Testing: Patient-reported outcomes (self-reported pain levels) using a Visual Analogue Scale (VAS).

8. The Sample Size for the Training Set

• Not applicable. Riva Star is a physical medical device, not an AI/machine learning algorithm requiring a training set.

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

• Not applicable, as there is no training set for this device.

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Remesense for Sensitive Teeth is intended for use as a tooth desensitizer.

'Sylphar Remesense for Sensitive Teeth' is an identical device to 'Remedent Remesense', cleared for marketing in the US by FDA under K082594. 'Remedent Remesense' was cleared as a 'prescription only' (Rx) device. The purpose of this 510(k) submission is to present additional data so that 'Sylphar Remesense for Sensitive Teeth' may be cleared by FDA for marketing as an 'over-the-counter' (OTC) device in addition to a prescription device under a new name. The labeling, both on the device box and in the instructions sheet provided in the box, has however been revised to include the new product name and provide additional information to better accommodate sale as an OTC device. The component parts of the device are: Outer box, Pre-formed dental tray in a plastic bag, 3 x Two foam strips impregnated with glycerin, aqua, dipotassium oxalate, aroma, EDTA, methylparaben, citric acid and saccharin, Plastic packaging for the foam strips, with foil covering, Instruction sheet. Sylphar Remesense for Sensitive Teeth uses dipotassium oxalate crystals to block the tubules in the teeth of patients suffering from acute tooth hypersensitivity. By blocking the tubules, it stops the signals from hot or cold food reaching the dental nerve, providing a rapid remedy for hypersensitivity.

The provided document for Sylphar Remesense for Sensitive Teeth describes a 510(k) submission to clear the device for over-the-counter (OTC) use, building upon a previous clearance for prescription-only use. The submission focuses on comparing the device to predicate devices and addressing suitability for OTC marketing rather than establishing new performance criteria through a traditional clinical study with defined acceptance criteria and statistical endpoints.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly available in the provided document. The submission is focused on demonstrating substantial equivalence to predicate devices and suitability for OTC labeling, rather than meeting specific performance criteria like a new device validation study would entail.

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

• Test Set: Not applicable in the traditional sense of a clinical trial test set for device performance. The two "studies" performed were:
  • A questionnaire sent to US dentists. The sample size for this is not provided.
  • A usability study of the subject device. The sample size for this is not provided.
• Data Provenance:
  • Questionnaire: US dentists (prospective, as it was sent out).
  • Usability Study: The location of the usability study is not specified, and it's unclear if it was prospective or retrospective, though usability studies are typically prospective.

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

This is not applicable as the "studies" conducted were not designed to establish a "ground truth" in the manner of diagnostic or treatment efficacy studies.

• The questionnaire gathered input from "US dentists." Their specific qualifications beyond being dentists are not detailed.
• The usability study involved "patients suffering from tooth hypersensitivity," not experts establishing ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the "studies" were not designed to establish a "ground truth" requiring adjudicators.

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

No, an MRMC comparative effectiveness study was not conducted. The studies focused on dentist perception and patient usability for an OTC product, not on comparative effectiveness with human readers.

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

This is not applicable as the device is a physical product (tooth desensitizer), not an algorithm or software.

7. The Type of Ground Truth Used

There was no "ground truth" used in the context of clinical efficacy or diagnostic accuracy, as this was not the purpose of the submitted "performance data." The "questionnaire" aimed to understand dentist prescribing habits and information needs for OTC products, and the "usability study" aimed to assess patient's ability to select and understand the product for OTC use.

8. The Sample Size for the Training Set

This is not applicable. The device is not an AI/ML algorithm that requires a training set.

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.

Summary of the Document's Approach to Acceptance Criteria:

The document describes a submission seeking OTC clearance for a tooth desensitizer. Instead of presenting a new clinical trial with pre-defined performance acceptance criteria (e.g., a specific reduction in pain score over a certain period), the submission relies on:

1. Substantial Equivalence: Primarily, the device is considered "identical" to a previously cleared prescription device (Remedent Remesense, K082594) and is compared to other predicate devices (Centrix Senzzzz Aqua, K120176). The core argument is that the device itself has already been proven safe and effective for its intended use.
2. Suitability for OTC Use: To justify the change from prescription to OTC, the submission presents two "studies":
   • Dentist Questionnaire: The acceptance "criteria" here would likely be the satisfactory feedback from dentists indicating that they already recommend similar products for home use and that additional patient information (to be added to labeling) would suffice for OTC. The reported "performance" was that dentists "are routinely prescribing Rx tooth desensitizing products for patient home use" and that "additional information provided is merely a reinforcement of product instructions."
   • Usability Study: The acceptance criteria would relate to patients' ability to understand and safely use the product in an OTC setting, including correct selection and avoiding contraindications. The reported "performance" was that "patients suffering from tooth hypersensitivity are able to select the product from a display of other dental products, and also that patients who have conditions that are contraindicated for use of the subject device are unlikely to select the product." Recommendations for labeling improvements were also made.

In essence, the "acceptance criteria" were less about the clinical efficacy of the device (which was established via its predicate) and more about demonstrating that the device could be safely and effectively marketed and used by consumers without a prescription, with appropriate labeling adjustments.

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