The LunaGuard™ Nighttime Dental Protector is an over-the-counter, flexible and moldable one-piece dental guard consisting of a lightweight polycaprolactone (PCL) plastic material can diffuse and absorb grinding forces, along with the microperforations in the mouthguard, to protect the teeth from the grinding and clenching associated with bruxism.

When in place over the upper teeth, the guard maintains separation between upper and lower teeth, reducing noise and damage associated with teeth grinding. It is designed to fit around the teeth with no or minimal space in order to form a barrier between the upper and lower teeth. The lightweight, thin design allows for comfort while sleeping, and does not impede speaking, drinking, or breathing.

The LunaGuard™ material is self-fit by the user using the "boil and bite" method. Once submerged in hot but not boiling water, the dental guard turns clear when it reaches 160 degrees Fahrenheit (71.1 degrees Celsius), indicating readiness to mold. At this point, the user shapes the dental guard around their upper teeth for a snug and user-specific fit.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a device called "LunaGuard Nighttime Dental Protector". This document primarily focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/ML-based medical device.

Therefore, much of the requested information about acceptance criteria, specific performance metrics (like sensitivity, specificity, or AUC), sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, and training set details, is not present in the provided document. This type of information is typically required for AI/ML device submissions where the algorithm's performance is the primary focus of review.

Here's a breakdown of what can be extracted and what is explicitly unobtainable from the provided text:

Unobtainable Information (due to the nature of this 510(k) for a physical device, not an AI/ML algorithm):

A table of acceptance criteria and the reported device performance: This document doesn't define AI-specific acceptance criteria or report performance metrics like sensitivity, specificity, or AUC. The performance data discussed is related to physical properties and biocompatibility.
Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The "test set" here refers to physical samples for material testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device would involve expert labeling of medical images/data. Here, "ground truth" for the physical properties would be lab measurements.
Adjudication method for the test set: Not applicable.
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: Not applicable, as this is not an AI-assisted device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical testing, ground truth refers to validated laboratory measurements and standards (e.g., ISO 10993 for biocompatibility).
The sample size for the training set: Not applicable (no AI/ML training set).
How the ground truth for the training set was established: Not applicable.

Information that can be extracted or inferred from the document:

The document describes the acceptance criteria and supporting study in terms of substantial equivalence for a physical device, not an AI/ML algorithm.

Device Name: LunaGuard™ Nighttime Dental Protector
Predicate Device: Pro Tech Dent (K121272), manufactured by Akervall Technologies Inc.
Indications for Use: The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding. (Identical to the predicate device).

Summary of "Acceptance Criteria" and "Device Performance" (in the context of a physical device's 510(k) ):

The "acceptance criteria" here are implicitly tied to demonstrating that the LunaGuard™ is substantially equivalent to the predicate device in terms of:

Intended Use and Indications for Use: Identical.
Design and Materials: Similar (both polycaprolactone (PCL) plastic, 1.6 mm thickness).
Method of Action and Principles of Operation: Similar (over-the-counter re-moldable dental guards, non-sterile, single user, boil-and-bite).
Physical Properties: Equivalent as demonstrated by comparative testing.
Biocompatibility: Device found biocompatible for its intended use.

Study Proving Device Meets "Acceptance Criteria" (i.e., Substantial Equivalence):

The studies conducted were non-clinical performance testing and biocompatibility testing.

Type of Study: Comparative performance testing and biocompatibility assessment.
Sample Size Used for Testing: The document does not specify the exact number of units or material samples used for the physical and biocompatibility tests. It broadly states "The physical properties of the LunaGuard™ device were tested against those of the predicate."
Data Provenance: The tests were performed in a laboratory setting for the purpose of this submission. The origin of the raw materials would be global, but the testing itself would be controlled by the manufacturer/testing labs. The document doesn't specify if this was retrospective or prospective testing, but for a 510(k), it's typically prospective testing of the manufactured product.
Ground Truth for Physical Testing: The "ground truth" for these tests would be the established scientific methods and standards (e.g., ISO 10993 for biocompatibility, and material characterization techniques like density, hot stage optical microscopy, hardness, melt flow rate, and tensile testing). The "truth" is the measured value compared against acceptable ranges or values of the predicate.
Qualifications of Experts for Testing: Not explicitly stated, but assumed to be qualified laboratory personnel following standard operating procedures for material and biocompatibility testing.
Adjudication Method: Not applicable for material testing; results are quantitative measurements.

Biocompatibility Testing Details:

Standard: ISO 10993-1: 2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
Device Categorization: Surface device, contacts intraoral (mucosal, gingival, palatal) surfaces for limited contact.
Result: Results show that the device is biocompatible for its intended use.

Non-Clinical Comparative Testing Details:

Comparison: LunaGuard™ vs. ProTech Dent (predicate).
Tests Performed: Density, hot stage optical microscopy, hardness, melt flow rate, and tensile testing.
Result: Found to be equivalent with respect to these properties.

Conclusion:

The provided document describes the regulatory submission for a physical medical device. The "acceptance criteria" and "study" refer to demonstrating substantial equivalence to a predicate device through material characterization and biocompatibility testing, not an AI/ML algorithm's diagnostic performance. Therefore, most of the detailed questions regarding AI/ML device testing are not applicable to this specific submission type.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

August 5, 2019

McKeon Products % Elizabeth FitzGerald Director, Regulatory Intelligence Right Submission LLC 59 High Street Newton, Massachusetts 02464

Re: K191033

Trade/Device Name: LunaGuard Nighttime Dental Protector Regulatory Class: Unclassified Product Code: OBR Dated: May 7, 2019 Received: May 8, 2019

Dear Elizabeth FitzGerald:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Srinivas Nandkumar, Ph.D. Acting Assistant 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 below.

510(k) Number (if known) K191033

Device Name

LunaGuard™ Nighttime Dental Protector

Indications for Use (Describe)

The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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K191033

5. 510(k) Summary

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

5.1 Submitter Information

Company:	Devin Benner
	CEO
	McKeon Products
	25460 Guenther
	Warren, MI 48091 USA
	Telephone: 586-427-7560
	devin@macksearplugs.com
Contact:	Elizabeth FitzGerald
	Director, Regulatory Intelligence
	Right Submission LLC
	59 High Street
	Newton, MA 02464 USA
	Telephone: 781-413-7345
	elizabeth@rightsubmission.com
Date Summary Prepared:	April 17, 2019

5.2 Name of the Device

Trade Name:	LunaGuard™ Nighttime Dental Protector
Common Name:	Over-the-Counter Dental Guard
Classification Name:	Mouthguard, Over-the Counter
Review Panel:	Dental
Regulation:	Unclassified
Class:	Class II
Product Code:	OBR

5.3 Equivalence Claimed to Predicate Device

The LunaGuard™ Nighttime Dental Protector is equivalent to the Pro Tech Dent (K121272), manufactured by Akervall Technologies Inc..

5.4 Device Description

The LunaGuard™ Nighttime Dental Protector is an over-the-counter, flexible and moldable one-piece dental guard consisting of a lightweight polycaprolactone (PCL) plastic material can diffuse and

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absorb grinding forces, along with the microperforations in the mouthguard, to protect the teeth from the grinding and clenching associated with bruxism.

5.5 Indications for Use

The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding.

The Indications for Use of the subject device is identical to the Indications for Use of the predicate device, the ProTech Dent.

5.6 Comparison of Technological Characteristics

The LunaGuard™ and the ProTech Dent have the same intended use and indications for use, and are similar in terms of design, materials, method of action, and principles of operation. They are over-the-counter re-moldable dental guards, provided non-sterile for a single user. They are composed of the same polycaprolactone (PCL) plastic material, are the same thickness (1.6 mm), and were found to have similar physical properties as demonstrated by comparative performance testing. Both were found to be biocompatible per ISO 10993.

5.7 Performance Data

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

Biocompatibility Testing

Biocompatibility testing on patient contacting materials was completed in accordance with the requirements of ISO 10993-1: 2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The LunaGuard™ is categorized as a surface device that contacts intraoral (i.e., mucosal, gingival, and palatal) surfaces for limited contact. Results show that the device is biocompatible for its intended use.

Non-Clinical Testing

The physical properties of the LunaGuard™ device were tested against those of the predicate. Comparative testing found the devices to be equivalent with respect to density, hot stage optical microscopy, hardness, melt flow rate, and tensile testing.

5.8 Conclusion

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Performance testing and comparison of technological characteristics between the LunaGuard™ and the predicate demonstrate that the LunaGuard™ is substantially equivalent with regard to intended use, operation, function, and technological characteristics.

Regulation Number and Section

N/A