DOLOTENS DENTAL TM 1 by NEUROMUSCULAR TECHNOLOGIES, INC.

The DOLOTENS DENTAL TM2 is an ultra low frequency muscle stimulator, sending an electrical impulse to the muscles via the nerves in order to provide a minor level of muscle contraction. This gentle contraction of the muscles provides a pumping action for the blood increasing circulation in the muscles. Muscle spasm is relieved because fresh nutrients are brought into the muscles and waste products are pumped out.

AI/ML Overview

The provided text describes a medical device, the DOLOTENS DENTAL™ 2, and its 510(k) summary for FDA clearance. However, it does not contain any information regarding acceptance criteria, device performance studies, or the methodologies for establishing ground truth, sample sizes, or expert qualifications that would typically be found in a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification (510(k)), which primarily establishes substantial equivalence to a predicate device. This type of submission generally focuses on comparing the new device's technological characteristics and indications for use to an already cleared device, demonstrating that it's as safe and effective, rather than presenting new clinical study data with acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria based on the provided text. The following points explain why:

No Acceptance Criteria or Performance Data: The document lists "Indications for Use" but does not define quantitative or qualitative acceptance criteria for these indications (e.g., "reduce TMJ pain by X% in Y% of patients"). It also does not present any performance data (e.g., sensitivity, specificity, accuracy, or clinical improvement rates) from a study that would demonstrate meeting such criteria.
No Study Details: There is no mention of a particular study (clinical trial, standalone study, MRMC study, etc.) conducted to evaluate the DOLOTENS DENTAL™ 2's performance against defined acceptance criteria.
Focus on Substantial Equivalence: The primary objective of the 510(k) summary is to state that the DOLOTENS DENTAL™ 2 is "substantially equivalent to the MODEL J-5 MVO-MONITOR (K031998)." This typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as the predicate device. It does not necessarily require new clinical performance studies with acceptance criteria if a well-established technological basis and predicate device exist.

Conclusion:

Based on the provided text, it's not possible to describe the acceptance criteria or a study proving the device meets acceptance criteria because this information is not present in the 510(k) summary document. The document's purpose is to seek FDA clearance for market entry based on substantial equivalence, not to present detailed performance study results against predefined acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows a date, "SEP - 2 2005". The month is September, the day is the 2nd, and the year is 2005. The text is in a bold, sans-serif font. The image is a close-up of the date.

Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K043373". The characters are written in a dark ink on a white background. The handwriting is somewhat messy and uneven.

510(k) Summary for the DOLOTENS DENTAL TM 2

Sponsor: Neuromuscular Technologies, Inc. Contact : Marie Jensen 17720 Jean Way #200 Lake Oswego, OR 97035 Phone : 503-320-4406 Fax : 503-675-7305 Email : mciensen17@yahoo.com

Proprietary Name of the Device: DOLOTENS DENTAL TM 2

Common Name: Muscle Monitoring Device

Product Code : KZM

Regulation Number: 890.1375

Substantial Equivalence: The DOLOTENS DENTAL TM 2 is substantially equivalent to the MODEL J-5 MVO-MONITOR (K031998), manufactured by MYOTRONICS-NOROMED, INC.

Indications for Use: The DOLOTENS Dental TM 2 is indicated for the following uses:

To treat temporomandibular joint (TMJ) dysfunction and associated pain. 1.
To relieve symptoms associated with muscle spasm. 2.
To relax muscles and establish a physiologic occlusion ని.
To take occlusal registrations 4.
To take denture impressions 5.
To increase local blood circulation 6.
To maintain or increase mandibular range of motion. 7.

Device Description: The DOLOTENS DENTAL TM2 is an ultra low frequency muscle stimulator, sending an electrical impulse to the muscles via the nerves in order to provide a minor level of muscle contraction. This gentle contraction of the muscles provides a pumping action for the blood increasing circulation in the muscles. Muscle spasm is relieved because fresh nutrients are brought into the muscles and waste products are pumped out.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

SEP - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marie Jensen Neuromuscular Technologies, Inc. 17720 Jean Way, #200 Lake Oswego, Oregon 97035

Re: K043373/S002

K045373/3002
Trade/Device Name: Transcutaneous Nerve Stimulator For Pain Relief Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: KZM Dated: August 25, 2005 Received: August 29, 2005

Dear Ms. Jensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in the may be readers in interests and referenced above and nave ucterinined the arreted predicate devices marketed in interstate for use stated in the enclosure/to regally manced promotive Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 20, 1970, the chaomience with the provisions of the Federal Food, Drug, devices that have been reculted in accordance with as records approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require apple rare a controls provisions of the Act. The You may, merelore, market the device, belger of the Benefits for annual registration, listing of
general controls provisions of the Act include requirements for annual regist general controls provisions of the receive required required in the branding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Exist. Box In addition EDA may be subject to such additional controls: Existing may organ In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Recepter be found in the Code of Federal Tregarations, in the Federal Register.

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Page 2 - Ms. Jensen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a bande complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decommanon that Jour stered by other Federal agencies. You must or any Pederal Statutes and regulations as imming, but not limited to: registration and listing (21 comply with all the Act 3 requirements, mercesses and actually of the provided of as set CFR Part 807); labeling (21 CFRT art 820); and if applicable, the electronic forth in the quanty systems (QD) regardin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctions of 1 vice as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your be I his letter will anow you to oegin manoming of substantial equivalence of your device to a legally premarket notheadon. The PDA midning of basification 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 If you desire specific advice ion your ac (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Comphaliso at (217) = 17 = 1 = 1 807.97). You may obtain " Misolanding by Icrerchec to premations in the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204, or Manufacturels, Internet and Octisal http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylvie Y. Michael Chird

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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Indications for Use

510(k) Number (if known): K043373

Device Name: DOLOTENS Dental TM2

Indications For Use:

To treat temporomandibular joint (TMJ) disfunction
and associated pain
To relieve symptoms associated with muscle spasm
To relax muscles and establish a physiologic occlusion
To take occlusal registrations
To take denture impressions
To increase local blood circulation
To maintain or increase mandibular range of motic

Prescription Use✓
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sya Rosela

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

510(k) Number

Page 1 of

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).