The BiteStrip is generally indicated for use by orofacial pain professionals or dentists, to aid in the evaluation and management of nocturnal masticatory muscles activity disorders, which may be related to the patient's bruxism. temporomandibular disorder (TMD) or other oral function disorders during sleep.

The BiteStrip is intended as an aid in the evaluation of excessive nocturnal jaw muscle activity The device is generally indicated for use by orofacial pain professionals or dentists, to evaluate nocturnal masticatory muscle activity level. which may be related to the patient's braxism. temporomandibular disorder (TMD) or other oral function disorders during sleep.

Device Description

The BiteStrip is a disposable diagnostic device. The device is intended for use in monitoring masseter muscle contractions during sleep. It is generally indicated for use by physicians to aid in the evaluation of the presence and severity of bruxism, to determine the need for treatment, and for treatment follow-up. The BiteStrip is specifically indicated to obtain a quantitative measure of masseter muscle contractions during sleep, which correlates with bruxism severity derived from formal sleep lab studies. The BiteStrip is intended for adult users during an overnight sleep episode, i.e., 4-6 hours.

The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3 (Where 0 is very low count, and 3 is high count) depending on the total number of masseter muscle contraction episodes that the patient performs for the duration of the test. This number is referred to as the Bscore. While both Bscore and traditional bruxism score are very similar, and have good correlation, the terms differ because the bruxism score is measured using sleep lab EMG and additional physiological measures (not only EMG signals), while the Bscore is obtained by EMG analysis alone.

AI/ML Overview

The provided text describes the BiteStrip device and its 510(k) summary, but it does not contain a detailed study report that proves the device meets specific acceptance criteria.

However, it does describe the device's intended use and mentions a correlation study without providing specific performance metrics or detailed methodology. I can extract the information that is present and note where information is missing.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the form of a table or specific measurable thresholds. It describes the device's output and how it correlates with bruxism severity.

Acceptance Criteria (Not explicitly stated, but implied goal)	Reported Device Performance (from text)
Aid in evaluation of nocturnal masticatory muscle activity	The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3 (Bscore).
	The Bscore correlates with bruxism severity derived from formal sleep lab studies.
	"While both Bscore and traditional bruxism score are very similar, and have good correlation..."

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "formal sleep lab studies" without further detail.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. It mentions "formal sleep lab studies" as the source of "traditional bruxism score" used for comparison.

4. Adjudication method for the test set

The document does not specify any adjudication method used for the test set.

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

The document does not describe an MRMC comparative effectiveness study directly involving human readers' improvement with or without AI assistance. The BiteStrip is presented as a diagnostic device that outputs a "Bscore," not as an AI-assistant for human readers.

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

Yes, the BiteStrip appears to be a standalone device that provides an automated output (the Bscore) based on EMG analysis. The description states: "The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3..." and "the Bscore is obtained by EMG analysis alone." This indicates standalone performance.

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

The ground truth used for comparison is the "traditional bruxism score" derived from formal sleep lab studies using sleep lab EMG and additional physiological measures.

8. The sample size for the training set

The document does not specify the sample size for any training set.

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

The document does not describe how the ground truth for a training set was established. It implies the device was developed to correlate with "traditional bruxism score" from formal sleep lab studies, which would serve as the reference.

Summary

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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle with three wing-like shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2005

Mr. Noam Hadas S.L.P., Inc. 18 Hazfira St. Tel-Aviv, Israel 67779

Re: K030869 Trade/Device Name: BiteStrip Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: KZM Dated: February 17,2004 Received: February 23,2004

Dear Mr. Hadas

This letter corrects our substantially equivalent letter of May 14, 2004, regarding the classification of your device which was incorrectly identified as "unclassified."

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 (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 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 - Mr. Noam Hadas

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 (OS) 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 continue 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" (21 CFR 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,

Chiu S. Lin, PhD
Chiu S. Lin, PhD

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT

510(k) Number: K030869

BiteStrip Device Name:

Indications for Use:

(P1.F.A.SE DO NOT WRITE BELOW THIS LINE.CONTINUE ON ANOTHER PAGE IF NEEDED)

510(k) Number

Prescription Use (Per 21 CFR 801.109) Over the Counter Usc

Susa Rumm
(Division Sign-Off)

esiology. General Hospital on Control, Dental

510(k) Number: kc30869

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MAY 1 4 2004

K030869

510(K) SUMMARY

BiteStrip

510(k) Number K030869

Applicant's Name: S.L.P Ltd. 18 Hazfira Street Tel-Aviv 67779, Israel Tel: 972-3-537-1281 Fax: 972-3-537-1282

Contact Person:	Tamar ShochatS.L.P Ltd.18 Hazfira StreetTel-Aviv 67779, IsraelTel: 972-3-537-1281Fax: 972-3-537-1282
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Trade Name:

BitcStrip

Classification Name:

Muscle Monitoring Device

Classification:

The FDA has classified Muscle Monitoring Device as class II devices (product code KZM, Regulation No. unknown) and they are reviewed by the Dental Panel.

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Predicate Device:

Model K6-I Diagnostic System (Myotronics-Noromed. Inc. USA) cleared . under K992694
. SleepStrip® Influent Ltd., Israel cleared under K002135
. ELECTROENCEPHALOGRAPH, (Nihon-Kohden America). cleared under K874796

Performance Standards:

The BiteStrip complies with the following recognized standards: EN 60601-1-1:90 + A1(93) + A11(93) + A12(93) + A2(95) + A13(96) EN 60601-1-2: 1993, EN 55011:1998 + A1:1999 class B

Intended Use:

Device Description:

Regulation Number and Section

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).