(183 days)
The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep.
GRINDCARE is a portable electromyographic (EMG) and electrical stimulation device. The device consists of a stimulator, a docking station and a tri-polar electrode. 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 stimulator. 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. In response to the EMG-measured contraction, it delivers mild electrical stimulation that is intended to relax the muscle and inhibit the bruxing event. The EMG events are logged and stored on the device. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.
The provided text refers to a 510(k) summary for the GRINDCARE device, a biofeedback device for nocturnal bruxism. However, the document provided does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance criteria beyond general conformity to standards.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit, quantitative acceptance criteria for the device's performance in reducing temporalis muscle EMG activity, nor does it report specific performance metrics against such criteria.
The "Performance Data" section states:
"Device testing was performed and the device was shown to meet its design specifications."
"Device performance will also be in conformance to the following standards prior to marketing: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-2-40."
"RF function of the device meets requirements of FCC CFR 47 Part 15, Subpart C."
These statements indicate that the device met internal design specifications and general safety/EMC standards, but they do not provide specific clinical performance metrics (e.g., % reduction in EMG activity, sensitivity, specificity for bruxing events). The "clinical data are provided to demonstrate safety and effectiveness" but the details of this clinical data (acceptance criteria, results) are not present in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the given 510(k) summary. The document mentions "Clinical data are provided to demonstrate safety and effectiveness," but it does not specify the sample size, type of study (prospective/retrospective), or data provenance for any clinical test set.
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)
This information is not provided in the given 510(k) summary. Given the nature of the device (EMG for bruxism), ground truth for bruxism events would typically involve clinical assessment or expert interpretation of polysomnography/EMG recordings, but no details are given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the given 510(k) summary.
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
This type of study is not applicable to the GRINDCARE device as described. The GRINDCARE is an electromyographic and electrical stimulation device that directly senses and treats bruxism; it is not an AI-assisted diagnostic tool for human readers/clinicians to interpret. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself operates as a standalone system to detect EMG activity and deliver stimulation. The text states: "It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. In response to the EMG-measured contraction, it delivers mild electrical stimulation..." This describes the device's standalone operation. However, no specific performance metrics for this standalone detection and stimulation (e.g., accuracy of bruxism detection, effectiveness of stimulation) are detailed in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for any clinical data that was provided. For a bruxism device, ground truth often involves polysomnography with EMG recordings, expert clinical diagnosis, or patient-reported outcomes, but this is not specified here.
8. The sample size for the training set
This information is not provided in the given 510(k) summary. The device uses signal processing to detect events, which implies some form of training or calibration, but details are absent.
9. How the ground truth for the training set was established
This information is not provided in the given 510(k) summary.
In summary, the provided 510(k) document is a high-level summary that indicates conformity to general safety and design standards and states that clinical data was provided to demonstrate safety and effectiveness for substantial equivalence. However, it explicitly lacks the detailed clinical study design, acceptance criteria, test set/training set sizes, ground truth establishment methods, and specific performance results that would answer most of your detailed questions. These details would typically be found in the full 510(k) submission, not in this brief summary.
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510(k) Summary 5.0
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the GRINDCARE device is provided below.
| Device Common Name: | Biofeedback device | MAR - 3 2010 |
|---|---|---|
| Device Proprietary Name: | GRINDCARE | |
| Submitter: | Medotech A/SMarielundvej 43A-DK-2730 HerlevPhone: +45 86 72 15 00 | |
| Contact: | Calley HerzogConsultantBiologics Consulting Group, Inc.Phone: 720-883-3633Fax: 720-293-0014Email: cherzog@bcg-usa.com | |
| ClassificationRegulation: | 21 CFR 890.1375 Diagnostic Electromyograph, Class II• 21 CFR 882.5050 Biofeedback device, Class II21 CFR 890.5850 Powered Muscle Stimulator, Class II | |
| Panel: | DentalNeurologyPhysical Medicine | |
| Product Code: | NUW: Stimulator, Muscle, Powered, DentalKZM: Device, Muscle Monitoring, Dental• HCC: Device, Biofeedback |
Indication for Use:
The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep.
Device Description:
GRINDCARE is a portable electromyographic (EMG) and electrical stimulation device. The device consists of a stimulator, a docking station and a tri-polar electrode.
...
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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 stimulator. 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. In response to the EMG-measured contraction, it delivers mild electrical stimulation that is intended to relax the muscle and inhibit the bruxing event. The EMG events are logged and stored on the device. 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.
Device performance will also be in conformance to the following standards prior to marketing:
- 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 60601-2-10: Medical Electrical Equipment Part 2: Particular Requirements for . the Safety of Nerve and Muscle Stimulators
- 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 device meets requirements of FCC CFR 47 Part 15, Subpart C. Clinical data are provided to demonstrate safety and effectiveness, and therefore, substantial equivalence of the GRINDCARE device for the proposed indication for use.
Substantial Equivalence:
The GRINDCARE device is a biofeedback device that is intended to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep. It uses EMG to sense contraction of the temporalis
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Image /page/2/Picture/1 description: The image shows a handwritten number, K092675. The number is written in black ink on a white background. The number is underlined with a black line. The handwriting is cursive and slightly slanted.
muscle that is associated with bruxing events. In response to the EMG-measured contraction, it delivers mild electrical stimulation that is intended to relax the muscle and inhibit the bruxing event.
GRINDCARE is substantially equivalent to the following predicate devices:
- SLP, Inc Bitestrip (K030869) .
- Myotronics Noromed Model J-5 Myomonitor (K031998) ●
- Cole and Associates Mentamove (K040849) .
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, resembling a flag or banner, positioned to the right of the text.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medotech A/S C/O Ms. Calley Herzog Consultant Biologics Consulting Group, Incorporated 13417 Quivas Street Westminster, Colorado 80234
MAR - 3 2010
Re: K092675
Trade/Device Name: Grindcare Regulation Number: 21CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: II Product Code: HCC Dated: February 24, 2010 Received: February 26, 2010
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.
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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,
Susan Turner
Anthony D. Watson, B.S., M.S., M.B.A. Director
Director
Division of Ana
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Eyaluation Center for Devices and
Radiological Health
Enclosure
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4.0 Indications for Use Statement
510(k) Number (if known):
Device Name: GRINDCARE
Indications For Use:
The GRINDCARE device is indicated to aid in the evaluation and management of nocturnal bruxism by reducing the temporalis muscle EMG activity during sleep.
Prescription Use × (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)
Suven Ray
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K092675
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§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.