FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Listerine® Sensitivity Defense™ Mouthrinse (LSDM) is a formulated device containing Dipotassium oxalate directed for twice-daily use to provide continual dentinal sensitivity relief. The oxalate formula relieves this painful tooth sensitivity by physically occluding dentinal tubules, preventing hydrodynamic flow, thereby preventing the painful stimulation of nerves within the tooth.

AI/ML Overview

This document describes the safety and effectiveness testing of a medical device, specifically a mouthwash (Listerine® Sensitivity Defense™ Mouthrinse), for reducing tooth sensitivity. The provided text does not contain typical "acceptance criteria" tables or the detailed study design elements found in AI/ML medical device submissions. Instead, it describes a clinical study to demonstrate substantial equivalence to predicate devices, focusing on clinical endpoints rather than algorithmic performance metrics.

However, based on the information provided, we can infer the "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of this 510(k) submission.

Inferred Acceptance Criteria & Reported Device Performance based on Clinical Study:

Acceptance Criteria Category	Specific Criteria (Inferred from Study Design)	Reported Device Performance & Outcome
Effectiveness - Primary Endpoints	Statistically significant improvement in primary sensitivity measures (likely air blast and tactile responses) compared to placebo at 2 and 4 weeks.	The test product group (LSDM) "provided a statistically significant improvement relative to the placebo group for all primary and secondary measures at 2 and 4 weeks."
"LSDM device was demonstrated to be superior to the placebo group in both the primary and the key secondary efficacy endpoints."
Effectiveness - Secondary Endpoints	Statistically significant improvement in key secondary sensitivity measures compared to placebo at 2 and 4 weeks.	See above for primary endpoints.
Safety - Adverse Events	Adverse events should be self-limiting, resolve without treatment or change in product usage, and not be serious. Expected adverse events for an oral rinse product are acceptable.	During the study, 7 test group subjects and 8 placebo group subjects experienced self-limiting adverse events, all of which resolved. All adverse events related to the test product were mild to moderate and resolved without treatment or change in study product usage. These were not unexpected. No serious adverse events occurred.
Biocompatibility	Compliance with ISO 10993 standards (e.g., for hypersensitivity, oral mucosa irritation, cytotoxicity).	Biocompatibility results indicate that all components in the LSDM device comply with ISO standards: ISO-10993-10:2010 (Maximization Test for Delayed-Type Hypersensitivity, Oral Mucosa Irritation Test), and ISO-10993-5:2009 (Cytotoxicity).
Bench Performance	Demonstration of physical occlusion of dentin tubules via in-vitro methods (e.g., scanning electron micrographs, hydraulic conductance).	The LSDM device "was tested in in-vitro, using recognized methods for dentin occlusion including scanning electron micrographs. Hydraulic conductance testing... demonstrated physical occlusion of dentin tubules compared to similar device controls."
Overall Conclusion	The device should be at least as safe and effective as predicate devices.	Based on non-clinical and clinical testing, the LSDM device is "at least as safe and effective as the predicate devices... therefore supporting that the LSDM device meets its intended use and is substantially equivalent to the predicate devices."

Here's the breakdown of the study details based on the provided text, addressing your specific points:

A table of acceptance criteria and the reported device performance:
- Please refer to the table above. The acceptance criteria are inferred based on the positive outcomes reported for the device in comparison to the placebo and the safety observations.
Sample sized used for the test set and the data provenance:
- Test set sample size: 375 subjects were evaluated in the clinical study. This was divided into:
  - 186 subjects in the placebo group
  - 189 subjects in the test product group (LSDM)
- Data provenance: The document states "A multi-center, double-blind, randomized, parallel-group study, controlled clinical study was conducted." This implies a prospective clinical trial. The country of origin is not explicitly stated, but the submission is to the US FDA for a US company, so it's most likely a US-based or international multi-center study coordinated for US regulatory purposes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a clinical efficacy study for a mouthwash, not an AI/ML device relying on image interpretation by experts to establish ground truth. The "ground truth" for tooth sensitivity was established through objective measures of sensitivity to stimuli (air blast and tactile) and patient self-reported measures. The study design does not mention external experts establishing "ground truth" in the way it's understood for AI/ML diagnostic devices (e.g., radiologists labeling images).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method (like 2+1 or 3+1 for expert review) is mentioned or relevant for this type of clinical trial where the "ground truth" comes from direct measurements and patient responses to stimuli. The "double-blind" nature of the study would ensure that neither subjects nor evaluators knew who received the active product or placebo, minimizing bias.
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 study was not done. This is a clinical trial for a consumer product (mouthwash) to demonstrate its direct effectiveness in reducing tooth sensitivity, not an AI medical device. Therefore, there's no concept of human readers improving with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is a human clinical trial evaluating the performance of a physical product (mouthwash) in humans. The "standalone" concept applies to AI algorithms whose performance is evaluated on a dataset without human intervention.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the clinical study was based on:
  - Objective measurements of response to stimuli: "qualifying response to stimuli for sensitivity measures (air blast and tactile)."
  - Patient-reported outcomes: While not explicitly detailed as "patient-reported," the "measures" evaluated at 2 and 4 weeks would encompass the patient's experience of sensitivity.
  - Clinical safety observations: Tracking of adverse events.
The sample size for the training set:
- This is not an AI/ML study, so there is no "training set." The study described is a clinical trial to prove efficacy and safety for regulatory approval.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned in the context of this device and study.

Summary

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.