The SleepRight® Original is indicated for the protection against bruxism or night time teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Device Description

An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 5 adjustments for the bite pads.

AI/ML Overview

The provided document, K100545, is a 510(k) summary for the SleepRight® Original Mouthguard, which is a device intended for the protection against bruxism or nighttime teeth grinding. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the SleepRight® -Low profile (K071404).

Based on the provided text, there is no acceptance criteria or a study described that proves the device meets specific acceptance criteria in the typical sense of a clinical trial with quantitative endpoints like sensitivity, specificity, or improvement in human reader performance. This 510(k) summary is a premarket notification for a Class I/Unclassified device, and the primary focus is on demonstrating "substantial equivalence" to a predicate device rather than presenting a performance study against predefined acceptance criteria.

The submission highlights comparisons of technical characteristics to a predicate device. This is a common approach for unclassified or Class I devices seeking 510(k) clearance, where safety and effectiveness are established by showing the new device is as safe and effective as a device already on the market.

Here's an analysis based on your requested information, acknowledging the limitations of a 510(k) summary for this type of device:

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

As stated above, this document does not present specific quantitative acceptance criteria and device performance metrics (e.g., accuracy, sensitivity, specificity) as one would find for an AI/clinical diagnostic device. Instead, the "acceptance" is based on demonstrating "substantial equivalence" to a predicate device across various features.

The key "performance" reported is essentially the similarity of the device to the predicate device in terms of its intended use, design, materials, and other characteristics.

Here's a table summarizing the comparison of the subject device (SleepRight® Original) to the predicate device (SleepRight® -Low profile), which serves as the basis for substantial equivalence:

Element of Comparison	Acceptance Criteria (based on predicate)	Reported Device Performance (SleepRight® Original)
Device Description	An adjustable protector that provides a barrier between upper/lower posterior teeth. Flexible connecting strap provides 4 adjustments for articulating bite pads.	An adjustable protector that provides a barrier between upper/lower posterior teeth. Flexible connecting strap provides 5 adjustments for the bite pads.
Material (Strap)	Elvax® strap	Elvax® strap
Material (Bite Pads)	Polypropylene and Kraton® bite pads	Polypropylene bite pads
Thermal Safety	Warm water (not boiling) recommended for fitting.	Same (Implied, as "Same" is stated for Thermal Safety)
Method of Manufacture	Injection Molded	Same (Implied, as "Same" is stated for Method of Manufacture)
Rx or OTC	Rx and OTC	OTC
Reusable	Yes, single patient	Same (Implied, as "Same" is stated for Reusable)
Sterile	No	Same (Implied, as "Same" is stated for Sterile)
Method of Disinfection	Cool water, mouthwash or toothpaste.	Same (Implied, as "Same" is stated for Method of Disinfection)
Design	Partial coverage, preformed oral appliance with adjustable bite pads. No boiling required.	Same except bite pads do not articulate.
Compatibility with Environment & Other Devices	Biocompatible materials used.	Same (Implied, as "Same" is stated for Compatibility)
Indications for Use	Protection against bruxism or nighttime teeth grinding. Intended to reduce damage to teeth and prevent noise associated with bruxing or grinding.	Same
Target Population	Individuals over 18 who clench and grind their teeth.	Same
Where used	For home use.	Same
Flavored	Yes	No

Summary of "Performance": The device's "performance" is considered acceptable because it shares the same fundamental scientific technology, intended use, and similar design and operating principles as the predicate device, with minor differences that do not raise new questions of safety or effectiveness. Notable differences (e.g., 5 adjustments vs. 4, Polypropylene only vs. Polypropylene and Kraton for bite pads, Not flavored vs. flavored) are implicitly deemed not significant enough to alter substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document does not describe a test set or data from a study with a sample size for performance evaluation. The submission relies on a comparison of technical characteristics to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set or ground truth established by experts is mentioned in this 510(k) summary. The ground for acceptance is substantial equivalence to a previously cleared device.

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

Not applicable. No test set or adjudication method is mentioned.

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

Not applicable. This device is a mouthguard, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader improvement are not relevant and not documented.

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

Not applicable. This device is a physical mouthguard, not an algorithm.

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

Not applicable. The concept of "ground truth" as typically applied in AI/diagnostic studies is not relevant here. The basis for clearance is the demonstrated substantial equivalence to a predicate device which has already established its safety and effectiveness for the intended use.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

Not applicable. As above, no training set or ground truth establishment is relevant to this type of device submission.

Summary

{0}------------------------------------------------

K100545

II. 510(k) Summary

JUN - 4 2010

This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.

Dr. T. J. Brown

General Information:

A. Submitted By:	Splintek, Inc.3325 Wyoming StKansas City, MO 64111Tel: 816-531-2008Fax: 816-531-1968
------------------	------------------------------------------------------------------------------------------------------

Contact Person:

May 27, 2010 Date Prepared

SleepRight® Original B. Device Trade Name:
Mouthguard Common Name:

Unclassified Classification Name:

SleepRight® -Low profile Predicate Devices: C.

Device Description: D.

An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 5 adjustments for the bite pads.

OTC Indications for Use: E.

Cautions: Do not use if you are under 18 years of age; have TMJ; have teeth or jaw caint or if the dental guard is broken or damaged. Do not use as an athletic mouth pains, or it als tuse for more than 12 hours in a 24 hour period. Not for use with dentures, braces or other dental appliances. Do not use for more than 3 months dentifely bruces or built consulting your dentist. Ask a dentist before use if you have loose fillings, loose caps, or unfilled cavities; jaw clicking or pain, teeth pain, face pain; difficulty chewing; mouth sores; gum disease or bleeding gums; or serious respiratory problems. While using the product, see your dentist at least

{1}------------------------------------------------

K100545

every 6 months. Stop use and see a dentist if you develop loose teeth or a change in every o months. "We're ain or other irregularity; the product easily falls out of your your bit, experience pain or other welg bleeding gums, soreness, or other reaction inside your mouth.

Element of Comparison	Subject DeviceSleepRight® Original	PredicateSleepRight® -Low profile
510(k) Number	K100545	K071404
Device Description:	An adjustable protector thatprovides a barrier betweenthe upper and lowerposterior teeth. Theflexible connecting strapprovides 5 adjustments forthe bite pads.	An adjustable protector thatprovides a barrier between theupper and lower posteriorteeth. The flexible connectingstrap provides 4 adjustmentsfor articulating bite pads.
Physical CharacteristicsMaterial	Elvax® strap,Polypropylene bite pads	Elvax® strap, Polypropyleneand Kraton® bite pads
Thermal Safety	Same	Warm water (not boiling) isrecommended for fitting.
Method of Manufacture	Same	Injection Molded
Rx or OTC	OTC	Rx and OTC
Reusable	Same	Yes, single patient
Sterile	Same	No
Method of Disinfection	Same	Cool water, mouthwash ortoothpaste.
Design	Same except bite pads donot articulate	Partial coverage, preformedoral appliance with adjustablebite pads. No boilingrequired.
Compatibility withEnvironment & OtherDevices	Same	Biocompatible materials used.
Indications for Use	Same	Protection against bruxism ornighttime teeth grinding. It isintended to reduce damage tothe teeth and to prevent thenoise associated with bruxingor grinding.
OTC	Same
Target Population	Same	Individuals over the age of 18who clench and grind theirteeth.
Where used	Same	For home use.
Flavored	No	Yes

Comparison of Technical Characteristics to Predicate Device: F.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle-like emblem with three stylized shapes representing the human form. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

JUN - 4 2010

Power-Products-Incorporated-Splintek · C/O Ms. Melaine Hasek Senior Regulatory Affairs Manager PRA International 9755 Ridge Drive Lenexa, Kansas 66219

Re: K100545

Trade/Device Name: SleepRight® Original Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: May 28, 2010 Received: June 1, 2010

Dear Ms. Hasek:

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.

{3}------------------------------------------------

Page 2-Ms. Melanie Hasek

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.html 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

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

{4}------------------------------------------------

K100545

I. Indications for Use:

Indications for Use Form

510(k) Number (if known):

Device Name: SleepRight Original

Indications For Use [Over The Counter (OTC)]:

The SleepRight Original is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page_1_of_1_

510(k) Number: K100545

Splintek, Inc.

Page 2 of 11

Regulation Number and Section

N/A