Jiajian® TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain.

Device Description

Jiajian® TENS, is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires and 9 volt type 6F22 battery. When using this device, the physician should select and use 510(k) cleared electrodes. The area of electrodes must be larger than 8cm2. The electronic stimulatory module has the operating elements of (1) Display screen, 2 Menu keys, 3 Modification keys, 4 On/Off key, 5 Battery compartment and (6) Outlet socket. The display screen can show (a) battery power, (b) selected program, (c) lasting time or left time of a program, (d) current intensity for each channel, (e) program phase and (f) locking state. The menu key "P" is for selecting standard program or user-program, and for locking; the menu key "E" is for editing program when the device is not being locked. The modification key "3A" and "3B" are for intensity level adjustment during stimulation. The outlet socket is used to connect skin electrodes by lead wires. The device has 12 selectable programs, which can be grouped into 4 output modes, i.e. Normal mode (P1, P2, P3, P4, P5, P6), Burst mode (P7, P12), Rate & width modulation (P8), and Intensity modulation (P9, P10, P11).

AI/ML Overview

The provided document is a 510(k) summary for the Jiajian® TENS device and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

However, based on the information provided, here's what can be extracted and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., pain reduction scores, patient satisfaction). Instead, it focuses on demonstrating technical equivalence and compliance with safety standards as a basis for being "substantially equivalent" to a predicate device.

The table below summarizes the comparison of technical specifications between the new device and the predicate device. While not acceptance criteria in the sense of clinical study endpoints, these indicate the technical specifications that the new device meets and how they compare to the predicate.

Parameter	Acceptance Criteria (from predicate)	Reported Device Performance (Jiajian® TENS)
Functional/Safety Characteristics
Intended Use	For symptomatic relief and management of chronic intractable pain, adjunctive treatment in the management of post surgical and post traumatic pain	For symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain.
Power Source	9V Battery type 6F22	9V Battery type 6F22
Average DC current through electrodes (no pulses)	<0.01μA	<0.01μA
Number of Output Modes	5	4
Number of Output channels	2	2
Channel Isolation	By Transformer	By Transformer
Regulated Current or Voltage	Voltage control	Voltage control
Software/Firmware/Microprocessor Control	Yes	Yes
Automatic Overload Trip	No	No
Automatic No-Load Trip	No	No
Automatic Shut Off	No	Yes
User Override Control	No	No
On/Off Status Indicator	Yes	Yes
Low Battery Indicator	Yes	Yes
Voltage/Current Level Display	Yes	Yes
Compliance with Voluntary Standards	IEC 60601-1; IEC 60601-1-2; IEC 60601-2-10	IEC 60601-1; IEC 60601-1-2; IEC 60601-2-10
Compliance with 21 CFR 8988	Yes	Yes
Physical/Output Characteristics
Weight (grams)	170g without battery	115g (battery included)
Dimensions (mm) [W x H x D]	1145927 mm	1016124.5mm
Housing Materials & Construction	ABS; Injection molded	ABS; Injection molded
Waveform	Monophasic	Asymmetrical biphasic
Shape	Rectangular pulse	Rectangular pulse
Maximum Output Voltage (volts)	36V @500Ω	50 V @500Ω
Maximum Output Current	72mA @500Ω	100mA @500Ω
Pulse Duration (μsec)	60μS and 300μS	50μS and 300μS
Frequency (Hz) [or Rate (pps)]	0.5Hz and 120 Hz	2Hz and 150 Hz
Net Charge (μC per pulse)	0.7776μC @500Ω	0.945μC @500Ω
Maximum Phase Charge, (μC)	21.6μC @500Ω	30μC @500Ω
Maximum Average Current, (mA)	2.592mA @500Ω	4.5 mA @500Ω
Maximum Current Density, (mA/cm², r.m.s.)	1.71mA/cm² @500Ω	1.33mA/cm² @500Ω
Maximum Average Power Density, (W/cm²)	11.73mW/cm² @500Ω	3.7mW/cm² @500Ω

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

Not applicable. This document is a 510(k) submission for a TENS device, which typically relies on demonstrating substantial equivalence to a predicate device through technical and safety comparisons, rather than a clinical trial with a "test set" of patient data. The safety testing mentioned (IEC standards) would involve hardware testing, not human subjects.

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

Not applicable. As above, no clinical "test set" with ground truth established by experts is described in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical "test set" or adjudication method is described.

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

Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC comparative effectiveness study involving human "readers" and AI assistance is entirely irrelevant to this device type.

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

Not applicable. This device is a physical TENS unit, not an algorithm. Its "performance" is measured by its electrical output characteristics and compliance with safety standards, not by an algorithm's classification accuracy.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)

Not applicable. Since this is a TENS device and the submission focuses on substantial equivalence and safety standards, the "ground truth" relates to compliance with engineering and electrical safety specifications defined by standards like IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10. This is verified through objective testing against these standards, not against clinical expert consensus or pathology.

8. The sample size for the training set

Not applicable. There is no "training set" for this device as it does not involve machine learning or AI models.

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

Not applicable. As there is no training set, there is no ground truth for it.

Summary

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

Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi, China Phone: 86 510-88745788 | Fax: 86 510-88746629 | URL: http://www. jjmed.cn

ILA (/an a

Section 5 510(k) Summary [As required by 21 CFR 807.92]

[As required by 21 CFR 807.92

1. Submission Information:
510(k) Number:	K112288
Date:	March 15th, 2012
Type of 510(k) Submission:	Traditional
Basis for 510(k) Submission:	New device
Submitter/Manufacturer:	Wuxi Jiajian Medical Instrument Co., Ltd
	Qinghong Rd., Ehu Town, Xishan District, Wuxi, China 214116
Contactor:	Doris Dong
	[Consultant, from Shanghai CV Technology Co., Ltd.]
	Add.: Room 1706 Yuesha, No. 128 Songle Rd., Songjiang, Shanghai, China 201600
	E-mail: doris_d@126.com
	Tel: 86 21-31261348
	Fax: 86 21-37824346

Device Description: Proprietary Name: Common Name: Classification Name: Regulation Number: Product Code: Device Class: Review Panel: Device Description:

Jiajian® TENS TENS (Transcutaneous Electrical Nerve Stimulator) Transcutaneous electrical nerve stimulator for pain relief 882.5890 GZJ II Neurology

Jiajian® TENS, is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin.

It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires and 9 volt type 6F22 battery.

When using this device, the physician should select and use 510(k) cleared electrodes. The area of electrodes must be larger than 8cm2.

The electronic stimulatory module has the operating elements of (1) Display screen, 2 Menu keys, 3 Modification keys, 4 On/Off key, 5 Battery compartment and (6) Outlet socket.

The display screen can show (a) battery power, (b) selected program, (c) lasting time or left time of a program, (d) current intensity for each channel, (e) program phase and (f) locking state.

The menu key "P" is for selecting standard program or user-program, and for locking; the menu key "E" is for editing program when the device is not being locked.

The modification key "3A" and "3B" are for intensity level adjustment during stimulation.

The outlet socket is used to connect skin electrodes by lead wires.

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

Wuxi Jiajian Medical Instrument Co., Ltd na (Juan a Qinghong Rd., Ehu Town, Xishan District, Wuxi, China Phone: 86 510-88745788 | Fax: 86 510-88746629 | URL: http://www.jjmed.cn The device has 12 selectable programs, which can be grouped into 4 output modes, i.e. Normal mode (P1, P2, P3, P4, P5, P6), Burst mode (P7, P12), Rate & width modulation (P8), and Intensity modulation (P9, P10, P11). Jiajian® TENS is an electrical nerve stimulator indicated for use for pain relief Indications for use: by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain.

3. Substantial Equivalence to Predicate device:

Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission.

Parameters		New Device	Predicate Device
1.	510(k) Number:	K112288	K071951
2.	Device Name	Jiajian® TENS	TENS, Model EV-804
3.	Manufacturer	Wuxi Jiajian MedicalInstrument Co., Ltd	Everyway Medical InstrumentsCo., Ltd
4.	Accessories	Electrode cables and batteries	Electrodes, gel, electrodecables and batteries
5.	Intended use	For symptomatic relief ofchronic intractable pain andadjunctive treatment in themanagement of post surgicaland post traumatic pain.	For symptomatic relief andmanagement of chronicintractable pain, adjunctivetreatment in the managementof post surgical and posttraumatic pain
6.	Power Source(s)	9V Battery type 6F22	9V Battery type 6F22
	- Method of Line Current Isolation	N/A	N/A
	- Patient Leakage Current
	- Normal Condition (μA)	2μA	N/A
	- Single Fault Condition (μA)	N/A	N/A
7.	Average DC current through electrodeswhen device is on but no pulses are beingapplied (μA)	<0.01μA	<0.01μA
8.	Number of Output Modes	4	5
9.	Number of Output channels:	2	2
	- Synchronous or Alternating?	Synchronous	Synchronous
	- Method of Channel Isolation	By Transformer	By Transformer
10.	Regulated Current or Regulated Voltage?	Voltage control	Voltage control
11.	Software/Firmware/MicroprocessorControl?	Yes	Yes
12.	Automatic Overload Trip?	No	No
13.	Automatic No-Load Trip?	No	No
14.	Automatic Shut Off?	Yes	No
15.	User Override Control?	No	No
16.	Indicator	On/Off Status?	Yes	Yes
	Display:	Low Battery?	Yes	Yes
		Voltage/Current Level?	Yes	Yes
17.	Timer Range (minutes)		30 min or 1~99 min	5~60min or continuous, 5 min/step
18.	Compliance with Voluntary Standards?		IEC 60601-1; IEC 60601-1-2; IEC 60601-2-10	IEC 60601-1; IEC 60601-1-2
19.	Compliance with 21 CFR 8988?		Yes	Yes
20.	Weight (grams)		170g without battery	115g (battery included)
21.	Dimensions (mm) [W x H x D]		1145927 mm	1016124.5mm
22.	Housing Materials & Construction		ABS; Injection molded	ABS; Injection molded
23.	Waveform		Monophasic	Asymmetrical biphasic
24.	Shape		Rectangular pulse	Rectangular pulse
25.	Maximum Output Voltage (volts)		36V @500Ω	50 V @500Ω
26.	Maximum Output Current (specify units)		72mA @500Ω	100mA @500Ω
27.	Pulse Duration (μsec)		The range of Pulse width control is between 60μS and 300μS.	The range of Pulse width control is between 50μS and 300μS.
28.	Frequency (Hz) [or Rate (pps)]		The range of Pulse rate control is between 0.5Hz and 120 Hz.	The range of Pulse rate control is between 2Hz and 150 Hz.
29.	Net Charge (μC per pulse)		0.7776μC @500Ω	0.945μC @500Ω
30.	Maximum Phase Charge, (μC)		21.6μC @500Ω	30μC @500Ω
31.	Maximum Average Current, (mA)		2.592mA @500Ω	4.5 mA @500Ω
32.	Maximum Current Density, (mA/cm², r.m.s.)		1.71mA/cm² @500Ω	1.33mA/cm² @500Ω
33.	Maximum Average Power Density, (W/cm²)		11.73mW/cm² @500Ω	3.7mW/cm² @500Ω
Substantial Equivalence Discussion:
Similarities between New device and Predicate Device:			intended use, power supply, output modes, output channels, pulse width control, pulse rate control, with microprocessor control, testing standards
Differences between New device and Predicate Device:			weight, dimensions, waveform, output voltage and current, net charge
Conclusion:		The maximum output voltage, maximum output current, and maximum phase charge of the new device are smaller than the predicate device. The maximum current density and maximum average power density are larger than the predicate device, but the values conform to the safety requirements of FDA regulation. In all important respects, the Jiajian® TENS are substantially equivalent to the TENS EV-804 (K071951). This conclusion is based upon comparison on design, technical characteristics, output mode, intended use, and safety standards complied with. Any differences in the technological characteristics do not raise any new safety and

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

K112288

Wuxi Jiajian Medical Instrument Co., Ltd
Qinghong Rd., Ehu Town, Xishan District, Wuxi, China
Phone: 86 510-88745788 | Fax: 86 510-88746629 | URL: http://www. jjmed.cn

ILAGUAN
HERBY

3 '

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

IVACUAN
BERRY

ব

4. Safety and Effectiveness of the device:

Jiajian® TENS is safe and effective as the predicate devices cited above.

The new device has passed testing according to the safety standards:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995;
IEC 60601-2-10 1987/Amendment 1 2001, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators; and
IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests

The conclusion drawn from the safety testing is that the new device is substantially equivalent to the predicate device. Furthermore, the new device complies with the recognized standards and performs its intended tasks as well as the legally marketed predicate devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

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

MAY - 2 2012

Wuxi Jiajian Medical Instrument Co., Ltd c/o Ms. Doris Dong Shanghai CV Technology Co., Ltd Room 1706, No. 128 Songle Rd., Songjiang Area , Shanghai, China 201600

Re: K112288

Trade/Device Name: Jiajian® TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: Not Dated Received: April 17, 2012

Dear Ms. Dong:

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.

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

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

Page 2 - Ms. Doris Dong

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,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Section 4 Indications for Use Statement

510(k) Number (if known):

Device Name:

Jiajian® TENS

Indications for Use:

Prescription Use ___ V (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)

CILC
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112288

Page 1 of 1

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).