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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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