Senzzzzz Away is an oxalate tooth desensitizing agent intended for over-the-counter-use. The combination of tubule occlusion and reduction in nerve excitability shown with oxalate formulations is responsible for the reduction in dentinal hypersensitivity to cold, hot and sweets. Senzzzzz Away is a one-part, opaque gel for single use.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the Senzzzzz Away device:

Important Note: The provided 510(k) summary for Senzzzzz Away (K120176) is for a dental cavity varnish. The questions in your prompt are largely tailored towards an AI/Software as a Medical Device (SaMD) product, which often involves metrics like sensitivity, specificity, MRMC studies, and ground truth established by experts. As such, many of the requested fields cannot be directly addressed from this type of regulatory submission for a physical medical device. I will extract all available information and explicitly state when a question cannot be answered from the provided text.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from study goals)	Reported Device Performance (from "Effectiveness Study")
Reduction in dental hypersensitivity	Demonstrated reduction in sensitivity (over 6 months)
Ease of use for over-the-counter application	Patient use determined to be appropriate for OTC purchase
Tubule occlusion	Seals and occludes dentinal tubules

Explanation of Inferred Criteria: The 510(k) summary doesn't explicitly state quantitative acceptance criteria or thresholds (e.g., "sensitivity must reduce by X%"). Instead, it describes the purpose of the studies, from which we can infer the criteria for success. The "effectiveness study" aimed to "demonstrate the reduction in sensitivity," implying that a statistically significant reduction in hypersensitivity was the acceptance criterion for effectiveness. The "consumer ease-of-use study" aimed to "ensure that patient use of the product was appropriate for over-the-counter purchase," indicating that the device needed to be readily usable and safe for consumers. The in vitro testing ("Scanning electron microscopy") aimed to show tubule occlusion and sealing, a key mechanism of action.

Study Details

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

Sample Size:
- Effectiveness Study: Not explicitly stated. The summary only mentions "A six month effectiveness study was performed."
- Consumer Ease-of-Use Study: Not explicitly stated. The summary only mentions "A consumer ease-of-use study conducted."
- Biocompatibility/SEM Study: Not explicitly stated for number of extracted teeth.
Data Provenance (Country of Origin, Retrospective/Prospective): Not specified in the provided text. The effectiveness and consumer studies would typically be prospective, but this is not explicitly stated. The biocompatibility/SEM analysis used "extracted teeth," which would be retrospective in terms of tooth origin, but the analysis itself is contemporary.

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

Not applicable / Not provided. For a dental desensitizer, "ground truth" often refers to clinical endpoints like patient-reported sensitivity or objective measurements of sensitivity. Expert consensus in the traditional sense of image analysis or diagnostic interpretation is not relevant here. The evaluation of effectiveness would typically rely on patient-reported outcomes (e.g., VAS scores for pain) and potentially some objective stimuli (cold, air blast, etc.) assessed by dental professionals, but the number and qualifications of such assessors are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not provided. This concept is generally associated with diagnostic studies where multiple readers interpret cases and their discrepancies are resolved. For a dental desensitizer's effectiveness study, adjudication methods like 2+1 or 3+1 are not typically used. The data would likely be collected directly from subjects and/or through objective measurements by trained clinical staff.

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. An MRMC study is specific to diagnostic imaging interpretation, often involving AI assistance. This device is a treatment for hypersensitivity. The "effectiveness study" was a clinical trial to demonstrate the device's therapeutic effect, not an MRMC study comparing human reader performance with and without AI.

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

No. This device is a physical product (cavity varnish) applied by a human, and it does not involve any algorithms or AI for standalone performance evaluation in the way a SaMD would.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Outcomes Data (patient-reported hypersensitivity) and Physical/Biological Evidence (tubule occlusion). The "effectiveness study" would have used methods to assess the reduction in dental hypersensitivity, likely through patient-reported pain scales (e.g., Visual Analog Scale (VAS) or similar) in response to stimuli (cold, hot, sweet, air blast), which are a form of outcomes data. The scanning electron microscopy (SEM) analysis provided direct biological evidence (ground truth) of tubule occlusion, confirming a key mechanism of action.

8. The sample size for the training set:

Not applicable / Not provided. This device does not use machine learning or AI that requires a "training set." The studies performed were clinical efficacy and consumer usability studies.

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

Not applicable / Not provided. As there is no training set for an algorithm, this question is not relevant to the described device.

Summary

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510(k) Summary

K120176

Senzzzzzz Away

510(k) Summary

Centrix, Inc.

JUL 2 5 2012

Senzzzzzz Away

July 12, 2012

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Centrix, Inc. 770 River Road Shelton, CT 06484 Telephone: +1 (203) 929-5582 Fax: +1 (203) 929-6804

Official Contact:

Greg Moreau RA/QA Director

Representative/Consultant:

Linda K. Schulz Allison C. Komiyama Floyd G. Larson PaxMed International, LLC l 1234 Ei Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: lschulz@paxmed.com akomiyama@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Senzzzzz Away
Classification Name:	Cavity Varnish
Classification Regulations:	21 CFR 872.3260, Class I
Product Code:	LBH
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch

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INTENDED USE

Senzzzzz A way™ is to be used to relieve dental hypersensitivity. or D/Sense® Crystal™ is to be used to relieve dental hypersensitivity.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Centrix, Inc., D/Sense® 1-Step cleared under K021146,

Phoenix Dental, Inc., Super Seal® Tooth Desensitizer cleared under K983477 and K 120109

Sunstar Butler, Protect™ Tooth Desensitizer cleared under K050486

NovaMin Technology, Inc., Oralief™ Therapy for Sensitive Teeth cleared under K040858

Remedent NV, Remesense cleared under K082594

Bisco, Inc., BisBlock cleared under K033521

Ultradent Products, Inc., UltraEZ Desensitizing Gel cleared under K061438

Device Name	Classification Name	Mode of Action	Application	Material
Senzzzzz Away(or D/Sense Crystal)D/Sense® 1-Step	Cavity varnish, Calciumhydroxide cavity liner	TubuleOcclusion	Paint-on gel	Oxalate
Super Seal® ToothDesensitizer	Cavity varnish	TubuleOcclusion	Applicator	Oxalate
Protect™ ToothDesensitizer	Cavity varnish	TubuleOcclusion	Paint on liquid	Oxalate
Oralief™ Therapyfor Sensitive Teeth	Cavity varnish	TubuleOcclusion	Brush on paste	Calcium sodiumphosphosilicate
Remesense	Cavity varnish	TubuleOcclusion	Tray andfoam strips	Oxalate
BisBlock	Calciumhydroxide cavity liner	TubuleOcclusion	Etch+applyliquid+seal	Oxalate
UltraEZDesensitizing Gel	Cavity varnish	TubuleOcclusion	Tray and gel	Potassium nitrateFluoride ion gel

Comparison of Technological Characteristics

Senzzzzz Away tooth desensitizer is the over-the-counter version of D/Sense® Crystal™ (previously D/Sense 1-Step). Senzzzzz Away is packaged in a single use tray with applicator for consumer use. All of the predicates use tubule occlusion as a mechanism for controlling dental hypersensitivity. Oxalate formulations also have an effect on nerve excitability to reduce pain sensitivity.

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510(k) Summary

Side-by-side biocompatibility testing was performed on the subject and predicate devices. Scanning electron microscopy images of extracted teeth before and after device application demonstrated that the device seals and occludes dentinal tubules.

A consumer ease-of-use study conducted for Senzzzzz Away to ensure that patient use of the product was appropriate for over-the-counter purchase. A six month effectiveness study was performed to demonstrate the reduction in sensitivity. The combination of these studies shows Senzzzzz Away is safe and effective for over-the-counter use.

Overall, Senzzzzz Away has the following similarities to the predicate devices:

. has the same intended use,
. uses a similar operating principle,
. incorporates the same basic design, .
incorporates the same or similar materials, and ●
. has similar packaging.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle in flight, rendered in blue. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

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

AUG -3 2012

Centrix. Incorporated C/O Ms. Linda K. Schulz PaxMed International. LLC 11234 Camino Real, Suite 200 San Diego, California 92130

Re: K120176

Trade/Device Name: Senzzzzz Away™ (OTC), D/Sense® Crystal™ (Rx) Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: June 29, 2012 Received: July 2, 2012

Dear Ms. Schulz:

This letter corrects our substantially equivalent letter of July 25, 2012.

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 (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.

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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Page 2- Ms. Schulz

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Anthony D. Watson, B.S., M.S., M.B.A.
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Indications for Use

K120176 510(k) Number:

Senzzzzz Away™ (OTC), D/Sense® Crystal™ (Rx) Device Name:

Indications for Use:

To relieve dental hypersensitivity.

Over-The-Counter Use X Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(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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Suna Runa

(Division Sign-Off) wision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K120176

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.