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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 29, 2015

Johnson & Johnson Healthcare Products Division of McNeil-PPC, Inc. C/O Ms. Angelina M. Hunt, RAC Director, Regulatory Affairs 199 Grandview Road Skillman, New Jersey 08558

Re: K143155

Trade/Device Name: Listerine® Sensitivity Defense™ Mouthwash Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: II Product Code: LBH Dated: October 31, 2014 Received: November 3, 2014

Dear Ms. Hunt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number, if known: K143155 Device Name: Listerine® Sensitivity Defense Mouthrinse

Indications for Use:

Provides continual relief from tooth sensitivity due to cold, heat, acids, sweets, or contact. Over-the-counter use.

Prescription Use OR Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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SECTION 5 - 510(k) SUMMARY

I. Submitter Information

Name:	Johnson & Johnson Healthcare ProductsDivision of McNeil-PPC, Inc.
Address:	199 Grandview Rd.Skillman, NJ 08558

Contact:	Angelina M. Hunt, RAC
Phone:	(908) 874-2943
Facsimile:	(908) 904-3712
Email:	ahunt2@its.jnj.com

Date Prepared: October 30, 2014

II. DEVICE

Name of Device:	Listerine® Sensitivity Defense™ Mouthrinse
Common or Usual Name:	Mouthwash / Oral Rinse
510(k) Number:	K143155
Regulatory Class:	II
Classification Name:	Cavity Varnish (21 CFR 872.3260)
Product Code:	LBH

III. PREDICATE DEVICE

Predicate Device:	Colgate® Desensitizing Mouthwash
510(k) Number:	K140481
Applicant:	Colgate-Palmolive Company
Predicate Device:	Oralief™ OTC Toothpaste for Sensitive Teeth
510(k) Number:	K080228
Applicant:	NovaMin Technology, Inc.

To our knowledge, the predicate devices have not been subject to a design-related recall.

Reference Device:	Crest® Sensi-Stop Sensitivity Relief Strips (SylpharRemesense)
510(k) Number:	K132426

COMPANY CONFIDENTIAL

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Applicant:

Sylphar N.V.

To our knowledge, the reference device has not been subject to a design-related recall.

IV. Device Description

V. INDICATIONS FOR USE

Intended Use: Relieves tooth sensitivity.

Indications for Use: Provides continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact. For over-the-counter use.

The Indications for Use statement for the LSDM is the same as the listed predicate devices. They are generally all indicated for providing relief from tooth sensitivity due to cold, heat, acids, sweets or contact. Additionally, the subject device and predicate devices are available over-the-counter for home use and have the same intended use for the relief of tooth sensitivity.

VI. COMPARISON OF TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The intended use, oral application and fundamental technology of the Listerine Sensitivity Defense Mouthrinse device is substantially equivalent to the predicate devices, Colgate Desensitizing Mouthwash and Oralief toothpaste for Sensitive Teeth. These devices contain a formulated occlusion technology that blocks the hydrodynamic flow within the open tubules. Open dentin tubules allow the fluid to transmit external stimuli to the nerves within the dentin pulp and to trigger a pain response, resulting in dentinal hypersensitivity. The components in the LSDM device physically form a thin film that acts like a seal, thereby physically restricting fluid movement through the dentin tubules and preventing external stimuli from triggering the pain response. The physical mechanism of action is responsible for the product's ability to achieve its intended purpose.

Technological characteristics differ in each formula composition between the subject device and the predicates; however, the fundamental scientific technology responsible for how the device achieves its intended use is the same.

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Device	ClassificationName	IntendedUse	TechnicalComposition/OccludingComponent	FundamentalTechnology /Mechanismof Action	UsageForm
Listerine®SensitivityDefense™Mouthrinse(LSDM)(K143155)	CavityVarnish	Relieffrom toothsensitivity	DipotassiumOxalate	Occlusion ofdentinaltubules	Mouthwash/Oral rinse
PredicateColgate®DesensitizingMouthwash(K140481)	CavityVarnish	Relieffrom toothsensitivity	Arginine	Occlusion ofdentinaltubules	Mouthwash/Oral rinse
PredicateOralief™ OTCToothpaste forSensitive Teeth(K080228)	CavityVarnish	Relieffrom toothsensitivity	Calciumsodiumphosphosilicate(NovaminTechnology)	Occlusion ofdentinaltubules	Non-aqueousToothpaste
ReferenceDeviceCrest® Sensi-StopSensitivityRelief Strips(SylpharRemesense)(K132426)	CavityVarnish	Relieffrom toothsensitivity	Oxalic Acid,Potassium Salt	Occlusion ofdentinaltubules	Gel strips

Table1: Intended Use and Technical Characteristic Comparison

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PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the LSDM device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standards (ISO) ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," and ISO-7405:2008 - Dentistry - Preclinical evaluation and biocompatibility of medical devices used in dentistry, as recognized by the FDA.

Biocompatibility results indicate that all components in the LSDM device comply with the ISO standards:

ISO-10993-10:2010 Maximization Test for Delayed-Type Hypersensitivity -
ISO-10993-10:2010 Oral Mucosa Irritation Test -
ISO-10993-5:2009 Cytotoxicity -

Bench Performance Testing

The LSDM device was tested in in-vitro, using recognized methods for dentin occlusion including scanning electron micrographs. Hydraulic conductance testing of the subject device using Dentin Permeability model demonstrated physical occlusion of dentin tubules compared to similar device controls based on various occlusion technologies.

Clinical Performance Testing

A multi-center, double-blind, randomized, parallel-group study, controlled clinical study was conducted to determine the safety and effectiveness for the LSDM device in reducing and controlling dentinal hypersensitivity.

375 subjects were evaluated with 186 in the placebo group and 189 in the test product group. The subjects had at least two teeth that satisfied the qualifying response to stimuli for sensitivity measures (air blast and tactile). Evaluations occurred at baseline, 2 and 4 weeks. Results indicated that the test product group provided a statistically significant improvement relative to the placebo group for all primary and secondary measures at 2 and 4 weeks. In summary, in this study, the LSDM device was demonstrated to be superior to the placebo group in both the primary and the key secondary efficacy endpoints.

During the study, 7 of the subjects in the test group and 8 in the placebo control group experienced self-limiting adverse events which all resolved. All of the adverse events considered related to the test product group were mild to moderate and resolved without treatment or a change in study product usage. These were not unexpected adverse events for an oral rinse product. There were no serious adverse events during the study.

COMPANY CONFIDENTIAL

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The results of the study conclude that the LSDM device showed statistically significant reductions in hypersensitivity at 2 and 4 weeks with twice-daily use supporting device effectiveness. All mild to moderate adverse events in the study groups resolved without treatment or change in study product usage and no serious adverse events were observed.

Summary

This study demonstrated that the LSDM device used twice daily as an adjunct to toothbrushing provided significantly greater efficacy in reducing and controlling dentinal hypersensitivity compared to a placebo mouth rinse. There were no serious adverse events during the study and the LSDM device was well tolerated. The LSDM device has been tested in non-clinical and clinical testing and has been shown to be safe and effective for its intended use.

VII. Conclusion

Based on the results of non-clinical and clinical testing on the LSDM device, the mouthrinse device is at least as safe and effective as the predicate devices through toxicological safety assessments, stability and in-vitro and clinical performance testing, therefore supporting that the LSDM device meets its intended use and is substantially equivalent to the predicate devices.

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.