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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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