The J-Stim 1000 is indicated for use as an adjuctive therapy in reducing the level of pain and symptoms associated with Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand.
The J-Stim 1000 external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee.
The J-Stim 1000 is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.

Device Description

The J-Stim 1000 consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

AI/ML Overview

The provided text is a 510(k) summary for the J-Stim 1000™, a Transcutaneous Electrical Nerve Stimulator (TENS) device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.

Based only on the provided text, here's what can be extracted and what information is not available:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., specific pain reduction percentages, range of motion improvements, or statistical significance levels) for the J-Stim 1000™.

Instead, the core of the submission revolves around establishing substantial equivalence to a predicate device, the Bionicare Stimulator, Model Bio 1000 (K030332). The "performance" reported is that the J-Stim 1000™ has identical electrical output compared to the predicate device.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (J-Stim 1000™)
Electrically identical to Bionicare 1000 predicate device (K030332)	Produces the same frequency
	Produces the same waveform (monophasic spiked shaped pulse)
	Produces the same voltage output range (0-12 volts peak)
	Same dual channel output performance
	Identical pulse widths
	Identical maximum output values
Indicated for use as an adjunctive therapy in reducing pain and symptoms associated with osteoarthritis of the knee and rheumatoid arthritis of the hand.	Intended use statement matches the predicate device's implied performance for these conditions.

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

The provided document does not describe any new clinical study or test set with human subjects that directly tested the J-Stim 1000™. The submission hinges on the established performance of the predicate device (Bionicare Stimulator, Model Bio 1000). Therefore, there is no sample size for a test set, nor is there data provenance mentioned for such a study in this document.

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

Since no new clinical study or test set for the J-Stim 1000™ is described, there is no information on experts used to establish ground truth.

4. Adjudication method for the test set:

As no new clinical study or test set for the J-Stim 1000™ is described, there is no information on an adjudication method.

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:

This question is not applicable to the J-Stim 1000™ TENS device. AI assistance and human reader improvement are concepts typically associated with diagnostic imaging or decision support systems, not with a TENS device.

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

This question is not applicable to the J-Stim 1000™ TENS device. It is a physical device that delivers electrical stimulation, not an algorithm.

7. The type of ground truth used:

For the purpose of this 510(k) submission, the "ground truth" for demonstrating the J-Stim 1000™'s effectiveness is established by the prior approval of the predicate device (Bionicare Stimulator, Model Bio 1000). The assumption is that because the J-Stim 1000™ is "electrically identical" to the predicate, it will have comparable therapeutic effects for the stated indications.

8. The sample size for the training set:

There is no mention of a training set in this document as it does not describe the development or testing of an algorithm, but rather a medical device seeking substantial equivalence based on its physical and electrical characteristics.

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

As no training set is mentioned, there is no information on how its ground truth was established.

Summary

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Ko73386

JUL 3 0 2008

. .

Pain Management Technologies, Inc. 510(k) submission J-Stim 1000™

510(k) Summary of Safety and Effectiveness (As described in 21 CFR 807.92)

Date Prepared:	11-1-07
Trade Name/Device:	J-Stim 1000™
Applicant Information:	Pain Management Technologies, Inc.1340 Home Ave. Bldg. AAkron, OH 44310800-239-7880 (phone)888-304-5454 (fax)Contact: Joshua LefkovitzRegistration No. 1528161
Device Generic Name:	TENS (Transcutaneous Electrical Nerve Stimulator)
Classification:	Class II (21CFR 882.1320)Classification Name: Transcutaneous electrical nervestimulator for pain reliefProduct Code: NYNRegulation number 21 CFR 882.5890
Predicate Devices:	The Bionicare Stimulator, Model Bio 1000 - K030332and the K052625

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Device Description:	The J-Stim 1000 consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.
Statement of intended use:	The J-Stim 1000 is indicated for use as an adjuctive therapy in reducing the level of pain and symptoms associated with Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand.

Summary of technology of the J-Stim vrs. the predicate Bionicare device:

The J-Stim 1000 and the Bionicare 1000 generate the exact same clectrical output. They produce the same frequency. The same wave form as a monophasic spiked shaped pulse. The same voltage output range which is 0-12 volts peak, as well as the same dual channel output performance. Pulse widths and max output values are identical as well. The J-Stim 1000 utilizes an LCD screen to display the settings

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pain Management Technologies % Mr. Joshua Lefkovitz President 1340 Home Avenue, Building A Akron, Ohio 44310

JUL 30 2008

K073386 Trade/Device Name: J-Stim 1000™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief. Regulatory Class: Class II Product Code: NYN Dated: June 6, 2008 Received: June 13, 2008

Dear Mr. Lefkovitz:

Re:

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

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Page 2 - Mr. Joshua Lefkovitz

forth in the quality systems (OS) regulation (21 CFR Part 820); and if 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Mark M. Mulkerson

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

Enclosure

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Pain Management Technologies, Inc. 510(k) submission J-Stim 1000TM

Indications for Use Statement

510k Number:K073386

Device Name: J-Stim 1000TM

Indication for Use:

The J-Stim 1000781 external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee.

The J-Stim 1000™ is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.

These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product. The product can be used in the home or clinic by all patients in need.

Prescription Use(Part 21 CFR 801 Subpart D)	√	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE)

Division Sign Off ONE ON ANOTHER PAGE
(IF NEEDED)

Division of General, Restorative,
and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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).