SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S. by SHIAN JIA MEEI ENTERPRISE CO., LTD.

SHIAN JIA MEEI TWO Channel Digital T.E.N.S.( Transcuntaneus Electrical Nerve Stimulator), is of independent two channels output , designed for symptomatic relief and management of chronic intractable pain. It provides a combination of adjustable frequency , adjustable Pulse Width and adjustable output current intensity. With large LCD panel. It is powered by 9V Battery. SHIAN JIA MEEI TWO Channel Digital T.E.N.S. requires the use of two (2) set of lead-wire and two (2) pairs of cutaneous stimulation electrodes. Model No. description TKL-008/ TKL-168/ TKL-268 is all the same except the Housing printing artwork , model no. & destination.

AI/ML Overview

The provided 510(k) summary (K052182) describes a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies with specific acceptance criteria in the manner of a new drug or novel medical device. Therefore, much of the requested information about device performance, sample sizes for test and training sets, expert consensus, and comparative effectiveness studies is not applicable to this specific submission type and device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Operating Specifications	Not explicitly listed as numerical targets. Implied to be similar to the predicate device.	"provides a combination of adjustable frequency, adjustable Pulse Width and adjustable output current intensity."
Safety Requirements	Conformance to EN 60601-1 and EN 60601-1-2.	"device conforms to applicable standards included EN 60601-1, EN 60601-1-2 & related FDA Output waveform requirements."
EMC Requirements	Conformance to EN 60601-1-2.	"device conforms to applicable standards included EN 60601-1-2."
Output Waveform	Conformance to "related FDA Output waveform requirements."	"device conforms to...related FDA Output waveform requirements."
Intended Use	Symptomatic relief and management of chronic intractable pain.	"The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is intended for symptomatic relief and management of chronic intractable pain." (Matches predicate)
Technological Characteristics	Similar to the predicate device (TRIO 300 Multi-mode Electrical Stimulator).	"The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. have the same intended use and similar technological characteristics as the TENS Mode of TRIO 300 Multi-mode Electrical Stimulator (K990787)."
Safety and Effectiveness (Overall)	Any differences in technological characteristics do not raise new questions of safety or effectiveness compared to predicate.	"bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."

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

Not Applicable (N/A). The submission is a 510(k) for a TENS unit, which typically relies on demonstrating substantial equivalence through engineering and electrical performance testing against recognized standards and comparison to a legally marketed predicate device, rather than patient-based clinical trials with "test sets" or "data provenance" in the context of diagnostic accuracy or clinical outcomes. The "bench testing" mentioned refers to laboratory tests of the device's electrical output and adherence to safety standards.

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

N/A. As this is a TENS device seeking 510(k) clearance, there is no mention of "ground truth" established by medical experts for a "test set" in the context of clinical performance or diagnostic accuracy. The compliance with electrical and safety standards is verified through engineering testing, not expert medical opinion on a dataset.

4. Adjudication method for the test set

N/A. There is no "test set" in the experimental design sense that would require an adjudication method by experts.

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

N/A. This device is an electrical nerve stimulator, not an AI-powered diagnostic or assistive tool. MRMC studies are completely irrelevant to this type of device and submission.

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

N/A. This device is a TENS unit, which is a physical medical device for therapy, not an algorithm. Therefore, "standalone performance" in the context of an algorithm or AI is not applicable.

7. The type of ground truth used

N/A. The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable to an electrical stimulator seeking 510(k) clearance. The "truth" in this context is the device's conformance to established electrical and safety standards and its functional equivalence to a predicate device.

8. The sample size for the training set

N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

N/A. As there is no training set, this question is not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a bench testing program demonstrating:

Compliance with Recognized Standards: The device conforms to EN 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance) and EN 60601-1-2 (Medical electrical equipment - Electromagnetic compatibility). It also meets "related FDA Output waveform requirements." These standards establish the acceptance criteria for electrical safety, performance, and electromagnetic compatibility.
Substantial Equivalence: The device's intended use (symptomatic relief and management of chronic intractable pain) and technological characteristics (adjustable frequency, pulse width, and output current intensity, two independent channels, 9V battery power, lead wires, cutaneous electrodes) are similar to the stated predicate device, the TRIO 300 Multi-mode Electrical Stimulator (K990787).
No New Questions of Safety or Effectiveness: The bench testing specifically demonstrated that any differences in the technological characteristics between the new device and the predicate device do not raise any new questions of safety or effectiveness.

In essence, the "study" for this 510(k) clearance is a set of engineering tests and a detailed comparison against a known, legally marketed predicate device to confirm safety and fundamental performance characteristics, as opposed to a clinical trial demonstrating efficacy against a specific outcome with human subjects.

Summary

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510(K) SUN

K052182

NOV - 4

T. . summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

1.	Submitter's Name:Address:Tel:Fax:	SHIAN JIA MEEI ENTERPRISE CO., LTD.NO.5,HUA YUAN 2ND ST., PEI HUA VILLAG, KUANG MIAO HSIANG,TAINAN HSIEN , TAIWAN · R.O.C.886-6-5960879886-6-5950259
	Contact:E-mail:	Mr. Michael Chen/General Managersjm58129@ms65.hinet.net
2.	Device NameTrade Name:	SHIAN JIA MEEI TWO Channel Digital T.E.N.S.
	Common Name:Classification name:	(Model no. TKL-008/168/268)TENS unitTranscutaneous Electrical Nerve Stimulator
3.	Classification:	Class II
4.	Predicate Device:	The predicate device is the TRIO 300 Multi-mode ElectricalStimulator (K990787) marketed by ITO CO., LTD.
5.	Device Description:	SHIAN JIA MEEI TWO Channel Digital T.E.N.S.( TranscuntaneusElectrical Nerve Stimulator), is of independent two channels output ,designed for symptomatic relief and management of chronicintractable pain. It provides a combination of adjustable frequency ,adjustable Pulse Width and adjustable output current intensity.
		With large LCD panel. It is powered by 9V Battery. SHIAN JIA MEEITWO Channel Digital T.E.N.S. requires the use of two (2) set oflead-wire and two (2) pairs of cutaneous stimulation electrodes.
		Model No. descriptionTKL-008/ TKL-168/ TKL-268 is all the same except the Housingprinting artwork , model no. & destination.
6.	Intended Use:	The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is intended forsymptomatic relief and management of chronic intractable pain.
7. Performance Summary:		In terms of operating specification, Safety & EMC requirements, thedevice conforms to applicable standards included EN 60601-1, EN60601-1-2 & related FDA Output waveform requirements.

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8. Conclusions:

The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. have the same intended use and similar nological characteristics as the TENS Mode of TRIO 300 Multi-mode Electrical Stimulator t the the the first of the formation of the formation of the formation of the formation of the formation of the formation of the formation of the formation of the formation o (K990787) marketed by ITO CO., LTD.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.

Public Health Service

NOV - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jennifer Reich Representing Shian Jia Meei Enterprise Co., Ltd. 3892 South America West Trail Flagstaff, Arizona 86001

Re: K052182

Trade/Device Name: Shian Jia Meei Two-Channel Digital TENS. Model # TKL-008, TKL-168, and TKL-268 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: August 8, 2005 Received: August 10, 2005

Dear Ms. Reich:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if

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Page 2 - Jennifer Reich

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin 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), nlease contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

signature

Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):__K 052182

Device Name: SHIAN JIA MEEI TWO Channel Digital T.E.N.S. (Model no. TKL-008/168/268) SHIAN JIA MEEI ENTERPRISE CO., LTD.

Indications For Use:

The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is intended for symptomatic relief and management of chronic intractable pain.

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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K052182
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Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).