The Stressgard™ Night Guard is indicated for protection from night-time teeth grinding, clenching and bruxism. It is intended to reduce damage to teeth and to prevent the noise associated with teeth grinding or bruxing.

Device Description

The TotalGard™ Stressgard™ Night Guard is composed entirely of a soft, flexible semitransparent FDA compliant material, Monprene® thermoplastic elastomers. As packaged, the Stressgard ™ Night Guard is ready for use by the consumer. If desired, the Stressgard™ Night Guard is easily trimmed by the consumer, however it requires no forming or molding for use.

AI/ML Overview

Here's an analysis of the provided text regarding the Stressgard™ Night Guard, focusing on the absence of performance data:

The provided 510(k) summary for the Total-Gard Corporation Stressgard™ Night Guard (K072968) explicitly states:

VIII PERFORMANCE DATA
No performance data is required in support of this 510(k) Notification.

This means that no specific acceptance criteria or study data demonstrating the device meets those criteria were provided or required for this particular submission. The FDA granted substantial equivalence based on other factors.

Therefore, I cannot populate the requested information regarding acceptance criteria and study details because the submission itself declares that no such data was needed.

Here’s a breakdown of what can be inferred from the document and why no further information is available for your specific questions:

A table of acceptance criteria and the reported device performance: Not applicable. No performance data was required or provided.
Sample size used for the test set and the data provenance: Not applicable. No test set data was required or provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a test set was established as no performance study was conducted.
Adjudication method: Not applicable. No performance study or ground truth establishment was conducted.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is typically for evaluating diagnostic accuracy with human readers and AI. The Stressgard™ Night Guard is a physical device, and its 510(k) submission did not involve such a study.
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: No. This device is a physical night guard, not an algorithm, and no such standalone performance study was conducted or required.
The type of ground truth used: Not applicable. No ground truth was established as no performance study was conducted.
The sample size for the training set: Not applicable. This refers to machine learning algorithms, which is not relevant for this physical device.
How the ground truth for the training set was established: Not applicable. This refers to machine learning algorithms.

Reasoning for "Not Applicable" or "No Data Provided":

The basis for the 510(k) clearance was "Substantial Equivalence" to predicate devices, as explained under section IX of the summary:

IX SUBSTANTIAL EQUIVALENCE
"The TotalGard™ Stressgard™ Night Guard is as safe and effective as the predicate devices. With respect to the physical composition of the Stressgard™ Night Guard, not unlike the predicate devices, the Stressgard™ Night Guard is comprised of FDA compliant Monprene® which has been determined to be safe and effective for use in FDA cleared medical devices. The Stressgard™ Night Guard has similar intended uses and indications as the predicate devices and the labeling and instructions are appropriate for over the counter use. As a result, the TotalGard™ Stressgard™ Night Guard is substantially equivalent to the predicate devices with respect to safety and effectiveness."

This means the FDA determined that because the device is made of similar materials (FDA compliant Monprene®), has comparable intended uses and indications as already cleared predicate devices (K053580, K072147, K071404), and appropriate labeling, it does not raise new questions of safety or effectiveness. Therefore, the detailed performance data typically associated with new or significantly different devices was not required for this submission.

Summary

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K072968

510 (K) SUMMARY TOTAL-GARD CORPORATION STRESSGARD "M NIGHT GUARD

510(K) NUMBER: _______________________________________________________________________________________________________________________________________________________________ JUL - 1 2008

SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE OF PREPARATION

Total-Gard, Corporation 800 West Cummings Park Suite 1550 Woburn, MA 01801

Contact: Glenn Bancroft, Vice President

Telephone: 888.447.1807 Facsimile: 781.376.0638

OR

Bell & Izzi, LLC 70 West Foster Street Melrose, MA 02176

Contact: Louis P. Izzi, Esq.

Telephone: 781.665.3360 Facsimile: 781.665.1321

Date Prepared: October 17, 2007

II NAME OF DEVICE

Stressgard TM Night Guard

III NAME OF SPONSOR, ADDRESS, TELEPHONE NUMBER AND CONTACT PERSON

Total-Gard, Corporation 800 West Cummings Park Suite 1550 Woburn, MA 01801

Contact Person: Glenn Bancroft, Vice President

Telephone: 888.447.1807 Facsimile: 781.376.0638

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510 (K) SUMMARY TOTAL-GARD CORPORATION STRESSGARD ™ NIGHT GUARD

510(K) NUMBER: 201

IV COMMON OR USUAL NAME

Dental Protector Nightguard

V PREDICATE DEVICES

Dental Concepts, LLC, The Doctor's® Nightguard™ (K053580) Dentek Oral Care, Inc., Comfort Fit Nightguard (K072147) Splintek-Power Products, Inc., SleepRight® (K071404)

VI INTENDED USE/INDICATIONS FOR USE

VII TECHNOLOGICAL CHARACTERISTICS

VIII PERFORMANCE DATA

No performance data is required in support of this 510(k) Notification.

IX SUBSTANTIAL EQUIVALENCE

The TotalGard™ Stressgard™ Night Guard is as safe and effective as the predicate devices. With respect to the physical composition of the Stressgard™ Night Guard, not unlike the predicate devices, the Stressgard™ Night Guard is comprised of FDA compliant Monprene® which has been determined to be safe and effective for use in FDA cleared medical devices. The Stressgard™ Night Guard has similar intended uses and indications as the predicate devices and the labeling and instructions are appropriate for over the counter use. As a result, the TotalGard™ Stressgard™ Night Guard is substantially equivalent to the predicate devices with respect to safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 2008

TotalGard Corporation C/O Mr. Louis P. Izzi Bell & Izzi, LLC 70 West Foster Street Melrose, Massachusetts 02176

Re: K072968

Trade/Device Name: Stressgard™ Night Guard Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: May 22, 2008 Received: May 23, 2008

Dear Mr. Izzi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Pagc 2 - Mr. Izzi

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clare

Chiu Lin, Ph,D, 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

510(k) Number (if known): ______________________

Device Name: Stressgard™ Night Guard

Indications For Use:

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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)

K. Setz DDS for Dr. Susan Renner

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

510(k) Number: K072968

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Regulation Number and Section

N/A