The FiteBac® Cavity Cleanser is a 2% K21 Quaternary Ammonium Silane-functionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. Research has shown that FiteBac® Cavity Cleanser can not only remove debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface. Clinical studies have not been conducted to demonstrate that this device results in improved clinical outcomes.

AI/ML Overview

The provided document, a 510(k) premarket notification for the FiteBac® Cavity Cleanser, details the device's characteristics and compares it to predicate and reference devices to establish substantial equivalence. However, this document does not describe a study that involves human-in-the-loop performance, multi-reader multi-case studies, or AI assistance. The "Performance Testing" section only lists "Bond Strength Testing." The "Non-Clinical Testing" section lists "Biocompatibility" (Cytotoxicity and Sensitization).

Therefore, based on the provided text, I cannot provide information for many of the requested points, especially those related to AI model performance, expert ground truth establishment for a test set, MRMC studies, or training set details. The document focuses on establishing substantial equivalence through comparison of technological characteristics and non-clinical bench testing.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the typical sense of a pre-defined performance threshold for a statistical study (e.g., AUC > X, sensitivity > Y%). Instead, it establishes substantial equivalence by demonstrating that the FiteBac® Cavity Cleanser has similar material properties and performs comparably in bench tests to legally marketed predicate and reference devices.

The "acceptance criteria" are implicitly met if the device demonstrates substantial equivalence to the predicate and reference devices in the evaluated characteristics. The "reported device performance" is essentially that it did achieve this equivalence in the listed non-clinical tests.

Trait Evaluated (Implicit Acceptance Criteria: Equivalent to Predicate/Reference)	FiteBac® Cavity Cleanser Performance	Predicate/Reference Performance (for comparison)	Comparison Result
Intended Use	Cleansing and moistening/re-wetting of cavity preparations	Cleansing and moistening/re-wetting cavity preparations (Bisco, Ascent)	Equivalent to predicate
Principle of Operation	Cleansing and re-wetting of carious preparations	Cleansing and re-wetting of carious preparations (Bisco, Ascent)	Equivalent to predicate
Composition	2% K21 QAS	2% Chlorhexidine Digluconate (Bisco), Chlorhexidine Gluconate (Ascent), 5% K18 QAMS (Lang)	Equivalent to reference (Lang Orthodontic Acrylic 2 shares QAMS compound)
Product Classification	Class II	Class II (all predicates/references)	Equivalent
Use	Prescription Use	Prescription Use (all predicates/references)	Equivalent
Biocompatibility	Yes (tested)	Yes (Bisco, Lang; unknown for Ascent)	Equivalent to predicate/reference
Bond Strength Testing (Performance)	Performed; results implicitly comparable to predicate to establish equivalence.	Performed (implied for predicates to be marketed).	Implied comparable to establish equivalence.
Cytotoxicity (Performance)	Performed; results implicitly acceptable.	Performed (implied for predicates to be marketed).	Implied acceptable for clearance.
Sensitization (Performance)	Performed; results implicitly acceptable.	Performed (implied for predicates to be marketed).	Implied acceptable for clearance.

Important Note: The document explicitly states: "Clinical studies have not been conducted to demonstrate that this device results in improved clinical outcomes." This reinforces that the acceptance is based on non-clinical, bench-top equivalence, not clinical performance metrics.

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

Test Set Sample Size: The document does not specify sample sizes for the bench tests (Bond Strength, Cytotoxicity, Sensitization). These are typically described in detailed study reports that are part of the 510(k) submission but are not fully reproduced in this summary letter.
Data Provenance: The document does not specify the country of origin of the data. It's safe to assume the testing was conducted to support a US FDA submission, but the specific location of the labs isn't stated. The testing is retrospective in the sense that it evaluates the device's properties, not prospective patient outcomes.

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

This question is not applicable to this document. The device is a "cavity cleanser," a chemical solution, not an AI diagnostic device that requires expert interpretation of images or other data to establish ground truth. The "ground truth" for chemical/physical properties is established by standardized laboratory methods and measurements, not by expert consensus.

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

This question is not applicable for the same reason as point 3. Adjudication methods are used in reader studies (often for AI or imaging devices) to resolve discrepancies in human interpretations. This device's evaluation is based on objective laboratory measurements.

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 comparative effectiveness study was NOT done. This document pertains to a chemical dental product, not an AI-assisted diagnostic tool.

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

No, this is not an AI algorithm. This question is not applicable.

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

The "ground truth" for this device's evaluation is based on standardized laboratory measurements and accepted scientific principles for material properties, bond strength, and biocompatibility (cytotoxicity, sensitization). It is not based on expert consensus, pathology, or clinical outcomes data in the context of a diagnostic study.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 23, 2020

Largent Health, LLC % Elizabeth O'Keeffe Director of Regulatory Affairs Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K190271

Trade/Device Name: FiteBac Cavity Cleanser Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: Class II Product Code: LBH Dated: January 8, 2020 Received: January 14, 2020

Dear Elizabeth O'Keeffe:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K190271

Device Name

FiteBac® Cavity Cleanser

Indications for Use (Describe)

The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/rewetting of cavity preparations.

Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of

information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301)443-6740 EF

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K190271

6 510(k) Summary

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the FiteBac® Cavity Cleanser is provided below.

Date	February 8, 2019
Submitted by	Largent Health, LLC3698 Largent Way NW, Suite 101Marietta, GA 30064Phone: 770-218-6221
510(k) Contact	Secure BioMed EvaluationsElizabeth O'Keeffe, Ph.D.7828 Hickory Flat Highway Suite 120Woodstock, GA 30188770-837-2681 (direct)Regulatory@SecureBME.com
Trade Name	FiteBac® Cavity Cleanser
Common Name	Varnish, Cavity
Code -Classification	LBH: Class II
Predicate Device	K915668 Bisco Cavity Cleanser
Reference Device	K070070 Ascent Dental Cleanser
Reference Device	K163482 Lang Orthodontic Acrylic 2

Device Description

Intended Use

The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.

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Technological Characteristics

The subject device has substantially equivalent technological characteristics to the predicate device and/or the reference devices in terms of principles of operation, intended use, material performance, and biocompatibility.

Non-clinical Testing - Bench Study Comparison

The subject device has mechanical and physical properties substantially equivalent to commercially available devices with the same intended uses. The following characteristics were evaluated

Performance Testing

. Bond Strength Testing

Non-Clinical Testing – Biocompatibility

Cytotoxicity
. Sensitization

Substantial Equivalence Summary (Conclusion)

FiteBac® Cavity Cleanser has the same intended use, principles of operation and substantially equivalent technological characteristics as the predicate device Bisco Cavity Cleanser (K915668) and the reference device Ascent Dental Cleanser (K070070). Although FiteBac® Cavity Cleanser differs from the predicate and reference devices in the source of solution component (K21 QAS versus Chlorhexidine Digluconate), FiteBac® Cavity Cleanser and the reference device Lang Orthodontic Acrylic 2 both use the same functionalized quaternary ammonium molecule found in the FiteBac® QAS molecule as a source of product component. The subject device and the predicate and reference devices active ingredients have been shown to effectively cleanse and prepare carious lesions for restoration without diminishing restoration bond strength. FiteBac® Cavity Cleanser is as safe and effective as the predicate and reference comparator devices currently cleared for marketing in the United States. Additional biocompatibility and non-clinical testing demonstrate FiteBac® Cavity Cleanser is as safe and effective as these devices and does not raise additional questions of safety and effectiveness.

A comparison of the subject device to the predicate devices is shown in the following table.

Trait	FiteBac® CavityCleanser™	Bisco Cavity Cleanser(Predicate)	Ascent Dental Cleanser(Reference)	Lang Orthodontic Acrylic(Reference)	Comparison/Equivalent to
510(k) number	TBD	K915668	K070070	K163482	N/A
FDA Regulation	872.3260	872.3690	872.3260	872.3760	Equivalent toreference
Product Code	LBH	EBF	LBH	EBI	Equivalent toreference
Trait	FiteBac® CavityCleanser™	Bisco CavityCleanser(Predicate)	Ascent DentalCleanser(Reference)	Lang OrthodonticAcrylic(Reference)	Comparison/Equivalent to
ProductClassification	Class II	Class II	Class II	Class II	Equivalent topredicate andreferencedevices
Use	Prescription UsePart 21 CFR 801Subpart D	Prescription UsePart 21 CFR 801Subpart D	Prescription UsePart 21 CFR 801Subpart D	Prescription UsePart 21 CFR 801Subpart D	Equivalent topredicate andreferencedevices
Intended Use	The FiteBac®Cavity Cleanser isa 2% K21 QASaqueous ethanolicsolution intendedfor cleansing andmoistening/re-wetting of cavitypreparations	BISCO's CavityCleanser is a 2%chlorhexidinedigluconateaqueous solutionintended forcleansing andmoistening/re-wetting cavitypreparations.	The Ascent DentalCleanser isindicated for thecleansing anddisinfecting only oftooth cavitypreparations inconjunction withdental restorativeprocedures	OrthodonticAcrylic 2 isintended for thefabrication ofmethacrylate-based orthodonticappliances (suchas retainers, biteguards, and biteplates, etc.)	Equivalent topredicate
Principle ofOperation	Cleansing and re-wetting of cariouspreparations	Cleansing and re-wetting of cariouspreparations	Cleansing ofcariouspreparations	Fabricatingorthodonticappliances	Equivalent topredicate
Composition	2% K21 QAS	2% ChlorhexidineDigluconate	ChlorhexidineGluconate	5% K18 QAMS	Equivalent toreferencedevice
AvailableConfigurations	Liquid	Liquid	Liquid	Liquid, Powder	Equivalent topredicate andreferencedevices
Size	8 mL	7 mL or 150 mL	unknown	Multiple sizes	N/A
Package	Low DensityPolyethyleneBottles	7 mL: Low DensityPolyethylene135 mL: HighDensityPolyethylene	unknown	High DensityPolyethyleneBottles	Equivalent topredicate
Biocompatibility	Yes	Yes	unknown	Yes	Equivalent topredicate andreferencedevices

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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.