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Sylphar Sensitivity Relief Strips are intended to aid in the relief of dentinal sensitivity resulting from cold, heat, acids, or sweets.

Remesense Sensitivity Relief Strips are polyethylene strips with dimensions of approximately 30 x 10 mm. On the strips is a gel which contains a tooth desensitizing agent, dipotassium oxalate. The directions for use provided with the device instruct the patient to apply one or more strips on the of any teeth that are causing sensitivity problems.

The dipotassium oxalate in the Remesense Sensitivity Relief Strips device forms oxalate crystals which block the open dentinal tubules, thus preventing the stimuli that may cause the sensitivity. By blocking the tubules, the crystals at the tooth surface stop the signals from hot or cold food reaching the dental nerve, providing a remedy for hypersensitivity.

The component parts of the subject device are:

• · Outer box with inner plastic sleeve
• · Foil pouches (2 or 18 per pack), each containing a single desensitizing strip, mounted on a plastic release backing
• The gel on each strip contains glycerin, aqua, potassium oxalate, carbopol, carboxy-methyl-. cellulose (CMC), potassium sorbate, sodium benzoate, sodium hydroxide (NaOH) (50% solution)
• Instruction sheet .

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sylphar Remesense Sensitivity Relief Strips:

Lack of Specific Acceptance Criteria and Detailed Study Information:

It's important to note that the provided 510(k) summary (K132426) for the Sylphar Remesense Sensitivity Relief Strips does not explicitly define specific quantitative acceptance criteria for its performance. Instead, it relies heavily on demonstrating substantial equivalence to a predicate device (Sylphar Remesense for Sensitive Teeth, K122708) by showing similar in vitro performance and a shared mode of action.

Consequently, many of the requested points about detailed study design, sample sizes, expert qualifications, and specific performance metrics cannot be found or fully elaborated from this document. The document focuses on establishing equivalence rather than presenting a de novo performance study against pre-defined clinical success criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information:

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

• In Vitro Pashley Model Test:
  • Sample Size: Not explicitly stated. The text notes "flow through human dentin," implying ex-vivo human tooth samples, but the number of samples is not provided.
  • Data Provenance: Implied to be laboratory-based ("in vitro test"). The country of origin for the human dentin samples is not specified. It's a retrospective analysis of the samples.
• Usability Study:
  • Sample Size: Not explicitly stated.
  • Data Provenance: Not specified (country, retrospective/prospective).
• Choking Risk Study:
  • Sample Size: Not explicitly stated.
  • Data Provenance: Conducted by a "third party laboratory." Not specified (country, retrospective/prospective).

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

• In Vitro Pashley Model Test: Ground truth here is the physical measurement of fluid flow reduction and observation of tubule occlusion. This is typically an objective, quantitative measurement based on physical principles, not a subjective "expert ground truth" in the clinical sense. There were technically no "experts" establishing a subjective ground truth, but rather trained laboratory personnel conducting the measurements.
• Usability Study: The "ground truth" for usability is patient comprehension and ability to use the device. The number of participants in this study, or any experts involved in assessing their comprehension (e.g., human factors specialists), is not specified.
• Choking Risk Study: The "ground truth" for choking risk would be objective assessment against safety standards. The number and qualifications of experts involved in this third-party lab study are not mentioned.

4. Adjudication method for the test set:

• Not applicable/Not mentioned, as the primary performance data described (in vitro flow reduction) relies on objective measurements rather than subjective assessments requiring adjudication. For the usability study, an adjudication method is not 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:

• No MRMC study was done or is applicable. This device is a topical dental product (desensitizing strips), not an AI-powered diagnostic imaging tool that would involve human readers.

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

• Not applicable. This is a physical product, not an algorithm. The "standalone" performance here refers to the device itself (the strips and gel) performing its intended physical function (tubule occlusion). The in vitro Pashley model test serves this purpose, demonstrating the device's inherent ability to reduce flow due to occlusion.

7. The type of ground truth used:

• In Vitro Pashley Model Test: The ground truth is based on objective physical measurements (reduction in fluid flow through dentin) and morphological observation (occlusion of dentinal tubules via cross-sectional analysis and elemental analysis). This is a laboratory-based, mechanistic ground truth.
• Usability Study: The ground truth is based on user comprehension and ability to perform tasks as instructed.
• Choking Risk Study: The ground truth would be based on objective safety assessment against relevant standards/parameters performed by a laboratory.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." The studies conducted are performance and safety evaluations of a physical product.

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

• Not applicable. As there is no AI/ML algorithm, there is no training set or ground truth established for it.

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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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