Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth.

Device Description

The devices are constructed of a thermal sensitive Elvax 4. strap and polypropylene and Kraton® bite pads. The bite pads may be adjusted for the individual patient. Although the two products look similar, the EZ-Splint, PM has an anatomically contoured shape for maximum cheek retention and stability during sleep. The EZ-Splint was designed as small as possible for speech and maximum flexibility when used in conjunction with dental and orthodontic work. The EZ-Splint's narrow shape makes it favorable for daytime use.

AI/ML Overview

The provided document does not describe an acceptance criteria or a study that proves a device meets specific acceptance criteria in the way typically expected for performance-based medical device studies (e.g., diagnostic accuracy, efficacy trials).

Instead, this document is a 510(k) summary for the EZ-Splint and EZ-Splint PM, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Here's the breakdown based on your requested information, highlighting what is and is not present in the document:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as performance metrics. The implicit "acceptance criterion" for a 510(k) submission is to demonstrate "substantial equivalence" to a predicate device. This is primarily established through comparison of indications for use, design, materials, method of manufacture, and regulatory status (prescription device, reusable, method of disinfection).
Reported Device Performance: No quantitative performance metrics are reported. The document states in its conclusion that "The E.Z-Splint and the EZ-Splint PM are safe and effective for their intended use," but this is a declarative statement based on the substantial equivalence argument, not on performance data.

The comparison presented is primarily a feature-by-feature comparison to predicate devices:

Feature	EZ-SPLINT EZ-SPLINT PM	Dr. HAYS BITE GUARD	NTI TENSION SUPPRESSION SYST.
Indication for Use	Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth.	Same	Same and for the prophylactic treatment of migraine pain.
Design	Adjustable, pre-formed oral appliance. The bite pads may be moved to adjust to the patient to prevent contact of posterior teeth and to provide a resilient break in the teeth clenching cycle.	Full mouth appliance that is custom molded by the practitioner for the patient.	Customized by the practitioner for the patient, fitted over the two maxillary central incisors with a dome shaped protrusion which extends lingually to prevent posterior of canine tooth contact
Materials	Elvax strap, Polypropylene and Kraton bite pads	Lexan and Elvax	Polycarbonate
Method of Manufacture	Injection molded	Dental laboratory molded	Injection molded
Prescription Device	Yes	Yes	Yes
Reusable	Yes, single patient	Same	Same
Method of de-infection	Warm water, soap, and toothbrush	Same	Same

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. The document explicitly states: "Non clinical tests were not performed" and "Clinical tests were not performed." Therefore, there is no test set, sample size, or data provenance relevant to performance evaluation described.

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. As no clinical or non-clinical tests were performed for this device, there was no "ground truth" established as part of a performance study. The ground truth for regulatory clearance in a 510(k) is the established safety and effectiveness of the predicate devices.

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

Not applicable. No test set or performance study was conducted for this device.

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 physical oral appliance, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with/without AI assistance is entirely irrelevant to this submission.

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

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

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

Not applicable in the context of a performance study for this device. For a 510(k) submission, the "ground truth" for demonstrating safety and effectiveness implicitly relies on the regulatory clearance and established performance of the predicate devices. The substantial equivalence argument posits that because this new device is similar enough to already-approved devices, it shares their safety and effectiveness profile.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is a physical device, not a machine learning model.

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

Not applicable. As there is no training set, there is no ground truth to establish for one.

Summary of Findings from the Document:

The provided document is a 510(k) premarket notification for the EZ-Splint and EZ-Splint PM. The key takeaway regarding performance studies and acceptance criteria is:

No new clinical or non-clinical performance studies were conducted or reported for the EZ-Splint and EZ-Splint PM to establish its own safety and effectiveness.
The manufacturer is asserting "substantial equivalence" to predicate devices (Dr. Hays Bite Guard and NTI Tension Suppression System) based on a comparison of indications for use, design, materials, manufacturing method, and regulatory attributes.
The FDA's letter confirms that the device was found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls. This means the FDA accepted the argument that the device's similarities to already-approved devices were sufficient to deem it safe and effective for its intended use without requiring new performance studies from the applicant.

Summary

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OCT 1 7 2003

Attachment 4 Revised 7/16/03

510(K) SUMMARY

Thi: summary of 510(k) safety and effectiveness information is being submitted in acc rdance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is K022809

1. Submitter's Identification:

Power Products, Inc. - Splintek 3325 Wyoming Street Kansas City, Missouri 64111 Phone: 816-531-1900

Carolann Kotula Contact Person: Official Correspondent for PPI-Splintek mdi Consultants, Inc. 55 Northern Blvd. Suite 410 Great Neck, NY 11021 Phone: 516-482-9001 516-482-0186 Fax: Alternate Phone: 770-985-8203 Alternate Fax: 770-736-8219 Email: ckotula@bellsouth.net
Date Summary Prepared: August 6, 2002

Name of the Device: 2.

Classification Name: Device, Jaw Repositioning

Common Name: Oral Occlusal Appliance or splint

Proprietary Name : EZ Splint and EZ Splint PM

Classification/Panel: These devices have not been classified. The Dental device panel will review this submission. The product code that has been assigned is LQZ.

ని. Predicate Device Information: These devices are substantially equivalent in design and intended use to the Dr. Hays Bite Guard, K104029, as well as the NTI Tension Suppression System, K010876. Both predicates are used by the patient

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to assist in the treatment and management of bruxism, teeth-grinding, and associated mandibular muscle tension and pain.

Device Description: The devices are constructed of a thermal sensitive Elvax 4. strap and polypropylene and Kraton® bite pads. The bite pads may be adjusted for the individual patient. Although the two products look similar, the EZ-Splint, PM has an anatomically contoured shape for maximum cheek retention and stability during sleep. The EZ-Splint was designed as small as possible for speech and maximum flexibility when used in conjunction with dental and orthodontic work. The EZ-Splint's narrow shape makes it favorable for daytime use.
1. Intended Use: Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome :hat is caused by chronic jaw clenching of the mandibular arıd maxillary teeth.
1. Comparison to Predicate Devices: Please refer to the following chart.

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Attachment 4 Revised 7/16/03

FEA URE	EZ-SPLINT EZ-SPLINT PM	Dr. HAYS BITE GUARD	NTI TENSION SUPPRESION SYST.
Indication for Use	Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interferer.ce. For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth.	Same	Same and for the prophylatic treatment of migraine pain.
Des gn	Adjustible, pre-formed oral appliance. The bite pads may be moved to adjust to the patient to prevent contact of posterior teeth and to provide a resilent break in the teeth clenching cycle.	Full mouth appliance that is custom molded by the practioner for the patient.	Customized by the practioner for the patient, fitted over the two maxillary central incisors with a dome shaped protrusion which extends lingually to prevent posterior of canine tooth contact
Ma erials	Elvax strap, Polypropelene and Kraton bites pads	Lexan and Elvax	Polycarbonate
Me hod of Manufacture	Injection molded	Dental laboratory molded	Injection molded
Pri scription Device	Yes	Yes	Yes
Re isable	Yes, single patient	Same	Same
Me thod of de infection	Warm water, soap, and toothbrush	Same	Same

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Non clinical tests were not performed.

1. Discussion of Clinical Tests Performed:

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Attachment 4 Revised 7/16/03

Clinical tests were not performed

. Conclusions:

The E.Z-Splint and the EZ-Splint PM are safe and effective for their intended use.

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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a symbol that appears to be a stylized representation of a caduceus, a traditional symbol of medicine, with a staff and two snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 17 2003

Power Products, Incorporated-Splintek C/O Ms. Carolann Kotula Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K022809

Trade/Device Name: EZ-Splint & EZ Splint PM Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: July 30, 2003 Received: July 31, 2003

Dear Ms. Kotula:

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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Page 2 -Ms. Kotula

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely vours.

Patricia Cucento for

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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Splintek-PPI EZ-Splint: EZ-Splint PM K022809

K022809

Attachment 3 Revised 7/16/03

1 Page -

510(k) Number (if known): K022809

Device Name: EZ-Splint; EZ-Splint PM

Indications For Use:

Protection against teeth grinding, bruxism and jaw clenching. .
Short-term pain relief from muscle spasm due to occlusal interference. ●
For the prevention of chronic tension and temporal mandibular joint (TMJ) . • syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:	K022809

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

N/A