To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C)

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for symptomatic relief and management of chronic, intractable pain associated with Arthritis (Choose Mode A)

To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B)

Device Description

The Pain Therapy System, Model PTS-II is a selectable dual channel TENS and EMS device operated by DC 3.0V (AAA*2 batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads.

There are 3 selectable, pre-programmed output waveforms (modes) to choose from. The two channels share one knob to adjust, the intensity are adjustable from 0 to 5. Running time can be selected among 10, 20 or 40min and recycled. There is a dial with on/off on the side that enables the device to be turned on or off, and it can be used to adjust the output intensity level, turn clockwise to increase intensity and turn anticlockwise to decrease the intensity. In the front of the device, there are 2 buttons and 6 indicator lights, in which one button is the mode selection button, and the other is for time selection. There are three modes A. B. C. respectively indicated by three indicator lights, which are on the right of the mode selection button. The device has 3 timing levels, namely 10, 20, 40 min, and indicated by three indicator lights, which are on the right of the timing selection button.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for a device called "Pain Therapy System, Model PTS-II". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Crucially, this document is for a Transcutaneous Electrical Nerve Stimulator (TENS) device, not an AI/ML medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity, or reader studies) are not applicable here. The substantial equivalence for this TENS device is established through non-clinical testing against recognized consensus standards and a comparison of technological characteristics with a legally marketed predicate device.

The questions you've asked (about sample sizes, ground truth experts, MRMC studies, standalone performance, training sets, etc.) are highly relevant to the evaluation of AI/ML medical devices. However, they do not apply to the traditional medical device evaluation process exemplified by this 510(k) submission for a TENS device.

Here's a breakdown of what is relevant from the document regarding its "acceptance criteria" (which are more accurately "conformance criteria" in this context) and "proof":

1. A table of acceptance criteria and the reported device performance:

Instead of acceptance criteria for AI performance, the document lists technological characteristics of the proposed device and compares them to the predicate device. The "acceptance criteria" here are essentially that the proposed device's characteristics are sufficiently similar to the predicate device, or any differences do not raise new questions of safety or effectiveness.

Parameter	Subject Device (Pain Therapy System, Model PTS-II) K150277	Predicate Device (OTC TENS, Model T1040 aka Aurawave) K124055
General
Power Source	3.0 v (2*1.5vAAA)	4.5 v (3*1.5vAAA batteries)
Method of Line Current Isolation	Use resistance to isolate	Use transformer to isolate
Patient Leakage Current (Normal Condition & Single Fault Condition)	N/A (implies within acceptable limits, not explicitly stated values)	N/A (implies within acceptable limits, not explicitly stated values)
Average DC current through electrodes when device is on but not connected to patient	0μA	0μA
Numbers of Output Modes	3 modes (A,B,C)	10 modes (Mode1-6, AUTO1-4)
Number of Output Channels	2 Synchronous	1 Synchronous
Method of Channel	Parallel connection	N/A
Regulated current or regulated voltage?	Regulated voltage	Regulated voltage
Waveform Parameters (Mode B for Subject Device, assumed comparable mode for Predicate)
Waveform (e.g. positive-going, reverse, biphasic)	Positive-going, Reverse and Biphasic	Positive-going, Reverse and Biphasic
Shape (e.g., spike, rectangular, square wave)	square wave	square wave
Maximum Output Voltage (Volts) (+/-15%)	88vp @500Ω (Mode B has max)102vp @2kΩ106vp @10kΩ	40.7vp @500Ω105.1vp @2kΩ154.1vp @10kΩ
Maximum Output Current (+/-15%)	176mA @500Ω (Mode B has max)51.0mA @2kΩ10.6mA @10kΩ	81.4mA @500Ω52.5.0mA @2kΩ15.4mA @10kΩ
Duration of primary phase	0	0
Pulse Duration	170 μs	200 μs
Frequency	1-136 Hz	1-250 Hz
For multiphase waveforms only: Symmetrical phases, Pulse Duration	Symmetrical phases, N/A	N/A
Net charge (micro coulombs μC) per pulse) (If zero, state method of achieving zero net charge.)	1.63μC @500Ω	1.9μC @500Ω
Maximum Phase Charge (μC)	29.9μC @500Ω	16.9μC @500Ω
Maximum Current Density (mA/cm2, r.m.s.)	8.31mA/cm² @500Ω	3.84mA/cm² @500Ω
Maximum Average Current (average absolute value), mA	2.22mA	1.28mA
Maximum Average Power Density (using smallest electrode conductive surface area)	$0.115mW/cm^2 @500\Omega$	$0.039mW/cm^2 @500\Omega$

The "reported device performance" is essentially the demonstrated compliance with the listed consensus standards and the presentation of these technological parameters. The conclusion (Page 8) states: "bench testing and safety report documentation demonstrate that the submitted device could maintain the same safety and effectiveness as that of predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This isn't a study involving human subjects or data sets in the AI/ML sense. The "testing" refers to bench testing and compliance with electrical safety and performance standards.
The device is manufactured by "Counter Scientific Development (GZ) Ltd" in Guangzhou, China.

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)

Not applicable. Ground truth in the AI/ML context is not relevant for this type of device submission. The "ground truth" here is the adherence to established engineering and safety standards.

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

Not applicable. No adjudication in the AI/ML context.

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. No MRMC study. This is a physical device, not an AI assistance tool for human readers.

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

Not applicable. Not an algorithm. The "standalone performance" is the device's ability to meet its operational specifications and safety standards on its own.

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

Not applicable. The "ground truth" for this device's evaluation is compliance with recognized consensus standards (ANSI/AAMI ES60601-1, IEC 60601-2-10, IEC 60601-1-2) which define safety and essential performance parameters, and the comparison of its technical specifications to a predicate device.

8. The sample size for the training set

Not applicable. No training set for an AI/ML model.

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

Not applicable. No training set.

In summary, the provided document details a 510(k) submission for a non-AI medical device (TENS). The evaluation methodology relies on comparison to a predicate device and compliance with established electrical and safety standards, rather than the AI/ML-specific testing and evaluation criteria you've outlined.

Summary

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Image /page/0/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

February 12, 2016

Counter Scientific Development (gz) Ltd % Guenter Ginsberg President Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135

Re: K150277

Trade/Device Name: Pain Therapy System, Model PTS-II Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NYN, NGX, GZJ Dated: January 8. 2016 Received: January 11, 2016

Dear Guenter Ginsberg:

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 device

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150277

Device Name

Pain Therapy System, Model PTS-II

Indications for Use (Describe)

To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C)

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for symptomatic relief and management of chronic, intractable pain associated with Arthritis (Choose Mode A)

To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Date of Summary Prepared: 02/11/2016

1. Submitter's Name:	Counter Scientific Development (GZ) Ltd2nd and 3rd Floor, Bldg 6, DaPian Industrial ZoneTangxia Road, Tianhe District, Guangzhou 510665, China
Contact person:	Jiang EagleTel: +86-20 -8328 9980Fax: +86-20-38339500

E-mail: Counter csd(@yahoo.com.cn & csd.counter(@gmail.com

2. Proposed New Device:

Trade Name: Pain Therapy System, Model PTS-II Classification Name: TENS/EMS Device Regulation Number: 882.5890 & 882.5850 Product Code: NUH, NGX, NYN, GZJ Device Class: II

3. Predicate (cleared) Device:

OTC TENS, Model T1040 aka Aurawave 510(k) Number: K124055 Manufacturer: Endurance Therapeutics

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4. Description of Proposed Device:

The device has been tested to and meets the requirements of the following recognized consensus standards:

ANSI/AAMI ES60601-1:2005+Corr.1(2006)+Corr.2(2007) general requirements for basic safety and essential performance

IEC 60601-2-10 Edition 2.0 2012-06 basic safety and essential performance of nerve and muscle stimulators. (Neurology)

IEC 60601-1-2 Edition 3:2007-03 medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests. (General II (ES/EMC))

5. Indication for Use:

This Pain Therapy System, Model PTS-II is:

To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A. B. or C)

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A. B or C)

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A., B or C)

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To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with Arthritis (Choose Mode A)

To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose ModeB)

6. Environment of Use:

Clinics, Hospitals and home environments

7. Contraindications:

Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electrical shock, burns, electrical interference, or death.

Do not use this device together with a life-supporting medical electronic device such as an artificial heart or lung.

Do not use this device together with a body-worn medical electronic device such as an ECG.

510(k) Number	K150277	K124055
Device Name and Model	PAIN THERAPYSYSTEM	T1040 aka AUrawave
Manufacturer	CounterScientific	Endurance Therapeutics
Power Source	3.0 v (2*1.5vAAA)	4.5 v ( 3*1.5vAAA batteries )
Method of Line Current Isolation	Use resistance to isolate	Use transformer to isolate
Patient Leakage Current	N/A	N/A
Normal Condition (μΑ)	N/A	N/A
Single Fault Condition (μA)	N/A	N/A
Average DC currentthrough electrodes when deviceis on but	0μA	0μA
Numbers of Output Modes	3 modes (A,B,C)	10modes(Mode1, Mode2, Mode3,Mode4, Mode5, Mode6,AUTO1, AUTO2, AUTO3,AUTO4)

8. Technological Characteristics Compared to the Predicate Device

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Number ofOutputChannels	SynchronousorMethod ofChannel	2 Synchronous	1 Synchronous
		Parallel connection	N/A
Regulated current orregulated voltage?		Regulated voltage	Regulated voltage

Parameter	Subject Device K150277	Predicate Device K124055
Mode or Program Name	PAIN THERAPY SYSTEM,	ELECTRO THERAPY PAIN RELIEF, T1040
Waveform (e.g. positive-going, reverse, biphasic )	Positive-going, Reverse and	Positive-going, Reverse and Biphasic
Shape(e.g., spike, rectangular, square wave)	square wave	square wave
Maximum Output Voltage ( Volts ) (+/-15%)	88vp @500Ω (Mode B has max)102vp @2kΩ106vp @10kΩ	40.7vp @500Ω105.1vp @2kΩ154.1vp @10kΩ
Maximum Output Current (+/-15%)	176mA @500Ω (Mode B has max)51.0mA @2kΩ10.6mA @10kΩ	81.4mA @500Ω52.5.0mA @2kΩ15.4mA @10kΩ
Duration of primary phase	0	0
Pulse Duration	170 μs	200 μs
Frequency	1-136 Hz	1-250 Hz
For multiphase waveforms only:	Symmetrical phasesPulse DurationN/A	N/A
Net charge (micro coulombs μC) per pulse) (If zero, state method of achieving zero net charge.)	1.63μC @500Ω	1.9μC @500Ω
Maximum Phase Charge (μC)	29.9μC @500Ω	16.9μC @500Ω
Maximum Current Density (mA/cm2, r.m.s.)	8.31mA/cm² @500Ω	3.84mA/cm² @500Ω
Maximum Average Current (average absolute value), mA	2.22mA	1.28mA
Maximum Average Power Density (using smallest electrode conductive surface area)	$0.115mW/cm^2 @500\Omega$	$0.039mW/cm^2 @500\Omega$

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9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

Counter did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the Pain Therapy System Model PTS-II vs. the predicate. Non-clinical testing was performed in order to validate the design according to the company's specified design requirements, and to assure conformance with the following voluntary design standards:

a. EMC and electrical safety

ANSI/AAMI ES60601-1:2005+Corr.1(2006)+Corr.2(2007) general requirements for basic safety and essential performance

IEC 60601-2-10 Edition 2.0 2012-06 basic safety and essential performance of nerve and muscle stimulators. (Neurology)

b. Biocompatibility

The electrode pads are the only body contacting parts. They have been FDA cleared under K132588.

c. Software

Based upon the test results it was concluded that the software performs within specifications and is safe to the stated intended use. Since a permanent hazard analysis is implemented in the software development process, and due to the clear software architecture, it is believed that the test protocol sufficiently verifies the software's main functional operation.

d. Cleaning

The cleaning instructions as described the Instruction Manual have been tested to be sufficient. Testing involved validation of the manual cleaning method as per the instructions. All testing concluded that the Pain Therapy System can be cleaned by the use of the methods described in the Instruction Manual.

8. Conclusions:

The Counter Pain Therapy System, Model PTS-II has the same intended use and 5 | Page

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technological characteristics as the predicate device. Moreover, bench testing and safety report documentation demonstrate that the submitted device could maintain the same safety and effectiveness as that of predicate device. In the other words, the differences do not affect the intended use and do not raise any new questions of safety or effectiveness or alter the fundamental scientific technology of the device. Thus, the Counter Pain Therapy System, Model PTS-II is substantially equivalent to the predicate device.

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).