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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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Remesense is intended for the local management of dental sensitivity by patient application of foam strips impregnated with desensitizing gel.
Remesense is indicated for use as a tooth desensitizer.

Remesense consists of a tray and impregnated foam strips. The Remesense foam strips are thin flexible foam strips, impregnated with a desensitizing liquid. These strips are designed to relieve dental (hyper) sensitivity by patient application to the affected tooth (teeth). The impregnated foam strips are held in place with trays.

Here's an analysis of the provided text regarding the Remesense device, focusing on the acceptance criteria and study information:

The provided 510(k) summary for K082594 for the Remesense device does not contain any information about acceptance criteria or a study proving the device meets those criteria.

This is a common characteristic of 510(k) submissions for devices seeking substantial equivalence to a predicate device. The primary objective of these submissions is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than to prove its performance against specific acceptance criteria through a clinical or performance study.

Therefore, many of the requested elements for a study design and results cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document does not specify any quantitative or qualitative acceptance criteria related to the device's efficacy in tooth desensitization, nor does it report any performance data from a study against such criteria. The submission is focused on demonstrating substantial equivalence based on technological characteristics and intended use.

Regarding the Study (if one were present):

Since no specific study proving the device meets acceptance criteria is described, the following points cannot be addressed from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, no study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no study described.
4. Adjudication method for the test set: Not applicable, no study described.
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 product, not an AI diagnostic tool, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a dental product, not an algorithm.
7. The type of ground truth used: Not applicable, no study described.
8. The sample size for the training set: Not applicable, no study described.
9. How the ground truth for the training set was established: Not applicable, no study described.

Additional Information from the 510(k) Summary:

While not directly about acceptance criteria or a performance study, the document does provide information relevant to the device's regulatory pathway:

• Substantial Equivalence: The primary conclusion is that "The information discussed above demonstrates that the Remesense device is substantially equivalent to the predicate devices." This is the basis for its clearance, not necessarily a direct demonstration of meeting pre-defined acceptance criteria through a new study.
• Predicate Devices: The submission relies on comparison to predicate devices, including UltraEZ (K061438), Orajel (K041680), SuperSeal (K983477), and Provident (K073061). The comparison table highlights similarities in indications for use (tooth desensitizer), mode of action (tubule occlusion), and often material composition (Potassium Oxalate for Remesense and Superseal).
• Technological Characteristics: The summary describes the mechanism of action: "Potassium oxalate breaks down into potassium and oxalic acid. The oxalic acid reacts with calcium ions to form calcium-oxalate crystals. These crystals block the dentin tubules, thereby alleviating dental sensitivity." This is presented as a "commonly used" method.

In summary, for this particular 510(k) submission, the "study" proving the device's suitability is the comparison to already-marketed predicate devices, demonstrating substantial equivalence in technology, intended use, and safety/effectiveness, rather than a de novo clinical trial with specific performance acceptance criteria.

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