To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
Muscle re-education
Increasing blood flow
Maintain or increase mandibular range of motion

Device Description

This device is a current stimulation device with Therapeutic Electro Muscle Stimulator function. Power is supplied by the built-in rechargeable lithium batter. The stimulation current generated by the output circuit of the main body is supplied to the user through the electrode to realize current stimulation. The device is equipped with PAIN mode and MCR mode. Each CH can output independently and be adjusted. If it outputs in CARE mode, it can be used for both outputs at the same time.

AI/ML Overview

Upon reviewing the provided document, it appears to be an FDA 510(k) clearance letter for a medical device called "D function," a powered muscle stimulator. The document primarily focuses on demonstrating the substantial equivalence of the "D function" to legally marketed predicate devices, rather than presenting a detailed study proving the device meets specific performance acceptance criteria for diagnostic accuracy or clinical effectiveness in the way one might expect for an AI/ML-based diagnostic device.

The document does not contain the following information typically found in a study proving a device meets acceptance criteria:

A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy.
Sample sizes used for test sets or data provenance for such studies.
Number of experts or their qualifications for establishing ground truth.
Adjudication methods for test sets.
MRMC comparative effectiveness study results.
Standalone performance results.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for and ground truth establishment for training sets (this device is a stimulator, not an AI/ML diagnostic).

Instead, the document focuses on:

Regulatory information: Device classification, product codes, predicate devices.
Device description: How the device works (current stimulation).
Indications for Use: What the device is intended to treat (muscle spasm, TMJ dysfunction, muscle re-education, blood flow, range of motion).
Comparison of technological characteristics: Comparing pulse width, output frequency, and output current with predicate and reference devices, highlighting differences and justifying how these differences are supported by existing devices.
Performance Data (Non-clinical Testing): This section refers to compliance with standards (e.g., electrical safety, EMC, software life cycle processes), and verification/validation that the device meets design/software requirements. It states that "The verification results demonstrate that the proposed device complies with the standard, IEC62304:2006/ Amd.1: 2015 Medical device software - Software life cycle processes. Additionally, the proposed device meets its design requirements in accordance with the requirements of FDA's guidance for the Content of Premarket Submissions for Software." It also states "The validation results demonstrate that the software specifications conform to user needs and that the particular requiremented through the proposed device can be consistently fulfilled."

Given the nature of this document (510(k) for a powered muscle stimulator), the "acceptance criteria" and "study" are primarily focused on non-clinical performance (electrical safety, electromagnetic compatibility, software validation, and physical/electrical specifications) to ensure the new device is as safe and effective as existing legally marketed predicate devices, despite some technological differences. It is not an AI/ML device, so typical AI/ML performance metrics (accuracy, sensitivity, specificity, AUC) are not applicable or presented.

Therefore, I cannot extract the information requested in the prompt as it pertains to AI/ML diagnostic device regulatory submissions, because this document describes a traditional medical device (a stimulator).

If you can provide a document related to an AI/ML medical device, I would be happy to attempt to extract that information.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".

May 5, 2021

Ito Co., Ltd. Takeshi Kobayashi Manager 3-1-8 Sakae-cho Kawaguchi-shi, Saitama 332-0017 Japan

Re: K203525

Trade/Device Name: D function Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NUW Dated: April 2, 2021 Received: April 5, 2021

Dear Takeshi Kobayashi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael Adjodha Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K203525

Device Name D function

Indications for Use (Describe)

To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain

ssociated pain
2) Muscle re-educatio

Muscle re-education 3) Increasing blood flow
Maintain or increase mandibular range of motion

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Exemption Under Part 677.904: Category B	One-Time Activity Under 677.904: Category C
-------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

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

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14.80

established in 1916

3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA 332-0017 JAPAN

TEL: +81-48-252-5015 FAX: +81-48-254-1041

510(k) Summary (K203525)

D function

SUBMITTER I. ITO CO., LTD. 3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA 332-0017 JAPAN

TEL: +81-48-252-5015 FAX: +81-48-254-1041

Contact Person: Takeshi Kobayashi Date Prepared: 05/04/2021

II. DEVICE

Name of Device:	D function
Common name:	Stimulator, Muscle, Powered, Dental
Regulation Number:	890.5850
Classification Name:	Stimulator, Muscle, Powered, Dental
Regulatory Class:	II
Product Code:	NUW

III. PREDICATE DEVICE PRIMARY PREDICATE DEVICE: MODEL J-5 MVO-MONITOR, K031998 REFERENCE DEVICE: TRIO 300, K990787

IV. DEVICE DESCRIPTION

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1180

established in 1916

3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA 332-0017 JAPAN

TEL: +81-48-252-5015 FAX: +81-48-254-1041

V. INDICATION FOR USE

To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and

associated pain

Muscle re-education
Increasing blood flow
Maintain or increase mandibular range of motion

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The legally marketed predicate device and the legally marketed reference device were selected for comparison to the D function, regarding substantial equivalence.

The main different specifications between the proposed device and the proposed device are described as below;

	Proposed Device	Predicate Device	Differences
Pulse Width	PAIN: 150 usCARE: 488 usMCR: 150 ms	488 us	The pulse width of MCR mode of theproposed device is longer than the pulsewidth of the predicate device.
OutputFrequency (Hz)	PAIN: 200CARE: 0.67MCR: 400	0.67	The frequency of the PAIN mode and MCRmode of the proposed device are higherthan the frequency of the predicate device.
Output Current	PAIN: 80 mACARE: 24 mAMCR: 750 µA	-24 mA	The current of PAIN mode of the proposeddevice is higher than the output current ofthe predicate device.

As shown in the table above, since the specifications of the proposed device and the predicate device are different, the reference device including fully specification ranges of the proposed device was indicated to support the substantial equivalence.

The proposed device is substantial equivalent to the predicate device, when each mode of the proposed device are used for the equivalent intended use of the predicate device or reference device, corresponding to intended use of each modes.

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伊藤超短波株式会社 MANUFACTURERS & EXPORTERS

ITOco.,LTD.

established in 1916

3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA 332-0017 JAPAN

TEL: +81-48-252-5015 FAX: +81-48-254-1041

Feature/Description	Proposed Device	Primary Predicate Device	Reference Device
Model Number	D function	Model J-5 Myo-Monitor	TRIO 300
Manufacturer	ITO CO., LTD.	Myotronics-Noromed, Inc.	ITO CO., LTD.
Regulatory Background
FDA 510(k) Number	K203525	K031998	K990787
Device Type	Stimulator, Muscle, Powered, Dental	Stimulator, Muscle, Powered, Dental	Stimulator, Muscle, PoweredStimulator, Nerve, Transcutaneous, For PainRelief
FDA Product Code	NUW	NUW	IPF, GZJ
FDA Regulatory Class	II	II	II
FDA Authorized Use	Prescription Use	Prescription Use	Prescription Use
Patient Therapy
Indications for Use	1) To relieve symptoms associated withmuscle spasm, to treat temporomandibularjoint (TMJ) dysfunction and associated pain2) Muscle re-education3) Increasing blood flow4) Maintain or increase mandibular range ofmotion	Used to relieve symptoms associated withmuscle spasm, to treat temporomandibularjoint (TMJ) dysfunction and associated pain,to relax muscles and establish a physiologicocclusion, to take occlusal registrations, totake denture impressions, to increase localblood circulation and to increase or maintainmandibularrange of motion.	Trio300 is indicated for the symptomaticrelief of chronic intractable pain, treatmentof post-traumatic and post-surgical pain,relaxation of muscle spasm, prevention orretardation of disuse muscle atrophy, musclereeducation, increase local blood circulation.maintain or increase range of motion,immediate post-surgical stimulation of calfmuscles to prevent venous thrombosis.
Physical Design
Physical Dimensions (in.) [W x H x D]	3.3 x 0.93 x 5.9	6.5x 2.56 x 6.97	2.7 x 0.98 x 4.4
Gross Weight	230 g	480 g	185 g
Accessory Attachment Method	Pad	Pad	Pad
Electrical Design
Electrical Safety & EMC Testing	ANSI AAMI ES60601-1 IEC 60601-1-2	unknown	IEC 60601-1 IEC 60601-1-2

Section 5

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伊藤超短波株式会社 MANUFACTURERS & EXPORTERS

ITOco.,LTD.

established in 1916

3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA

332-0017 JAPAN

TEL: +81-48-252-5015 FAX: +81-48-254-1041

Feature/Description	Proposed Device	Primary Predicate Device	Reference Device
	IEC 60601-2-10
Electrical Safety Class	Class II internally powered equipment, Type BF	Internally powered equipment, Type BF	Class II internally powered equipment, Type BF
Power Supply	DC 7.4 (Lithium ion battery)DC 12 V (AC adaptor)AC 100-240V, 50/60Hz	DC 9V (battery)	DC 9V (battery)DC 9V (AC adaptor)AC 120V, 60 Hz
Electrical input power	30 VA	-	420 mA
		Output Specification
Pulse Width	PAIN: 150 $μ$ sCARE: 488 $μ$ sMCR: 150 ms	488 $μ$ s	250 ms
Output Frequency (Hz)	PAIN: 200CARE: 0.67MCR: 400	0.67	400
Output Current	PAIN: 80 mACARE: 24 mAMCR: 750 $μ$ A	-24 mA	80 mA
Pulse Shape	rectangular	rectangular	rectangular
Channel Numbers	2	4	2
Other Functions
Timer	Yes	No	Yes
Buzzer	Yes	No	Yes
LCD	Yes	Yes	Yes

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Image /page/7/Picture/1 description: The image shows the logo for ITO Co., LTD. The letters are in a bold, sans-serif font. The letters "CO." and "LTD." are in a smaller font size than the letters "ITO."

established in 1916

3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA 332-0017 JAPAN

TEL: +81-48-252-5015 FAX: +81-48-254-1041

VII. PERFORMANCE DATA

Cited Standards to Determine Substantially Equivalence:

D function complies with the following FDA recognized:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment – Part1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment -- Part1-2: General requirements for basic safety and essential performance - Collateral standard Electromagnetic phenomena - Requirements and tests
IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment – Part2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

Non-clinical Testing:

Non-clinical verification and validation testing was conducted on D function device.

The verification results demonstrate that the proposed device complies with the standard, IEC62304:2006/ Amd.1: 2015 Medical device software - Software life cycle processes. Additionally, the proposed device meets its design requirements in accordance with the requirements of FDA's guidance for the Content of Premarket Submissions for Software.

The validation results demonstrate that the software specifications conform to user needs and that the particular requiremented through the proposed device can be consistently fulfilled. In addition, the proposed validation plan, procedure, testing and result provides evidence that all requirements have been implemented correctly and completely and is traceable to system requirements.

VIII. CONCULUSION

The non-clinical data support the substantial equivalence of the declared predicates and the hardware and software verification and validation demonstrate that the D function device should perform as intended in the specified use conditions.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).