GRINDCARE MEASURE is a portable electromyographic (EMG) monitoring device. The device consists of the recorder, a tri-polar electrode and a docking station. The electrode is placed on the forehead with three integrated electrodes in close connection to the temporalis muscle by means of a double-adhesive patch incorporating three conductive gelpads and connected to the recorder. The device records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching). It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. The EMG events are logged and stored on the recorder. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.

AI/ML Overview

The GRINDCARE MEASURE device underwent performance testing to ensure it met design specifications and complied with relevant standards. The provided document does not contain details about specific acceptance criteria related to clinical performance (e.g., sensitivity, specificity for bruxism detection) or a clinical study that proves the device meets such criteria. Instead, it references compliance with general electrical safety and electromagnetic compatibility standards, and that its performance was previously tested for the predicate device (K092675).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance
Electrical Safety	IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety	Meets requirements
EM Compatibility	IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests	Meets requirements
Electromyographs Safety	IEC 60601-2-40: Medical Electrical Equipment Part 2-40: Particular Requirements for the Safety of Electromyographs and Evoked Response Equipment	Meets requirements
RF Functionality	FCC CFR 47 Part 15, Subpart C	Meets requirements
Bouxism Detection	Not specified directly in terms of performance metrics like sensitivity/specificity for bruxism events.	"records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching)." "uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events."

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not explicitly stated. The document refers to "device testing" and meeting "design specifications" and existing standards, but does not detail a clinical test set or its size for bruxism detection performance.
Data Provenance: Not specified. Based on the manufacturer's location (Denmark) and the referenced standards, it's likely testing was conducted to international standards. Whether a dedicated clinical study with human subjects for the GRINDCARE MEASURE was performed, and its nature (retrospective/prospective, country of origin), is not detailed.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

This information is not provided. The document focuses on technical and electrical safety standards rather than clinical performance validation against expert-established ground truth for bruxism diagnosis.

4. Adjudication Method for Test Set:

This information is not provided. As there's no detailed clinical study described, there's no mention of an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study is not mentioned. The document does not describe any human-in-the-loop performance evaluation or comparison of human readers with and without AI assistance for the GRINDCARE MEASURE. The device is a diagnostic tool for measuring EMG activity, not an assistive AI for human interpretation.

6. Standalone (Algorithm Only) Performance Study:

Yes, in spirit, the device's ability to detect bruxing events represents a standalone performance. The document states: "It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. The EMG events are logged and stored on the recorder." This implies the device's internal processing (algorithm) identifies these events independently. However, specific standalone performance metrics (e.g., accuracy, sensitivity, specificity) against a clinical ground truth for bruxing events are not provided. The "performance data" section primarily lists compliance with technical standards.

7. Type of Ground Truth Used:

For the technical and safety standards, the ground truth would be the parameters defined by the respective IEC and FCC standards. For the detection of "bruxing events," the document implies that the EMG signals indicating muscle contraction serve as the basis for detection. However, it does not specify how the accuracy of this detection itself was validated against a gold standard for bruxism (e.g., polysomnography with video, expert observation, or clinical diagnosis).

8. Sample Size for Training Set:

This information is not provided. The document does not describe the development of an AI algorithm based on a training set for bruxism detection. The device "processes the signal to detect" events, but details on how this processing was developed or "trained" are absent.

9. How Ground Truth for Training Set Was Established:

This information is not provided as there is no mention of a training set for an AI algorithm in the provided text.

Summary

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

K113677

iof3

APR - 5 2012

510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the GRINDCARE MEASURE device is provided below.

Device Common Name:	Dental Muscle Monitoring Device
Device Proprietary Name:	GRINDCARE MEASURE
Submitter:	Medotech A/SMarielundvej 43A-DK-2730 HerlevPhone: +45 86 72 15 00
Contact:	Calley Herzog, ConsultantBiologics Consulting Group, Inc.Phone: 720-883-3633Fax: 720-293-0014Email: cherzog@bcg-usa.com
Date Summary Prepared:	March 1, 2012
ClassificationRegulation:	21 CFR 890.1375 Diagnostic electromyography, Class II
Panel:	Dental
Product Code:	KZM: Dental Muscle Monitoring Device
Predicate Devices:	GRINDCARE - K092675SLP, Inc Bitestrip - K030869

Indication for Use:

The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep.

Device Description:

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

K113677

273

connected to the recorder. The device records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching). It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. The EMG events are logged and stored on the recorder. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.

Performance Data:

Device testing was performed and the device was shown to meet its design specifications.

As stated in the previous 510(k) (K092675) device performance has been tested and meets the following standards which also apply to the GRINDCARE MEASURE:

IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety .
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for . Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-2-40: Medical Electrical Equipment Part 2-40: Particular Requirements for . the Safety of Electromyographs and Evoked Response Equipment

RF function of the GRINDCARE MEASURE meets requirements of FCC CFR 47 Part 15, Subpart C.

Conclusions drawn from testing:

The performance testing demonstrates that GRINDCARE MEASURE is safe and has acceptable performance for the proposed intended use and indication for use.

Substantial Equivalence:

The GRINDCARE MEASURE device is intended to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep. It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events.

GRINDCARE MEASURE is substantially equivalent to the following predicate devices:

. GRINDCARE (K092675)
SLP. Inc Bitestrip (K030869) .

510(k) Number	TBD	K092675	K030869
Manufacturer	Medotech	Medotech	SLP Inc
Device Name	GRINDCAREMEASURE	GRINDCARE	BiteStrip
510(k) Number	TBD	K092675	K030869
Manufacturer	Medotech	Medotech	SLP Inc
Device Name	GRINDCAREMEASURE	GRINDCARE	BiteStrip
Regulation	890.1375	890.1375, 882.5050	890.1375
Product Code	KZM	KZM, HCC	KZM (muscle monitoringdevice, dental)
Indication for Use	The GRINDCAREMEASURE device isindicated to aid in theevaluation ofnocturnal bruxism bymeasuring thetemporalis muscleEMG activity duringsleep.	The Grindcare deviceis indicated to aid inthe evaluation andmanagement ofnocturnal bruxism byreducing thetemporalis muscleEMG activity duringsleep.	The BiteStrip is generallyindicated for use byorofacial painprofessionals or dentists toaid in the evaluation andmanagement of nocturnalmasticatory musclesactivity disorders, whichmay be related to thepatient's bruxism,temporomandibulardisorder (TMD) or otheroral function disordersduring sleep.
BASIC UNITCHARACTERISTICS
Power Source	Lithium-ionrechargeable battery	Lithium-ionrechargeable battery	Lithium battery
Number of OutputChannels	N/A	1	N/A
SoftwareFirmware/Micro-processorControl	Yes	Yes	Yes

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

K113677

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

Public Health Service

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

APR - 5 2012

Medotech A/S · C/O Ms. Calley Herzog Consultant Biologics Consulting Group, Incorporated 13417 Ouivas Street Westminster, Colorado 80234

Re: K113677

Trade/Device Name: GRINDCARE MEASURE Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: II Product Code: KZM Dated: March 7, 2012 Received: March 8, 2012

Dear Ms. Herzog:

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.

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

Page 2 - Ms. Herzog

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.htm 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,

hh 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

{5}------------------------------------------------

Medotech A/S

GRINDCARE MEASURE

113677

18

Indications for Use Statement 4.0

510(k) Number (if known):

Device Name: GRINDCARE MEASURE

Indications For Use:

The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

C. Ross

Jivision Sign-Off) : vivision of Anesthesiology, General Hospital "Ifection Control, Dental Devices

: 10(k) Number: K113677

Page 1 of _1

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).