The MedRelief SE-50 and SE-100. and the MedRelief SE-200 and SE-300 in subthreshold and interferential modes, are intended for the following indications:

Relief of chronic intractable pain. .
Adjunctive treatment of post-surgical or post-traumatic acute pain. .

The MedRelief SE-200 and SE-300 in muscle stimulation mode are intended for the following indications:

Relaxation of muscle spasms. ●
Prevention or retardation of disuse atrophy. .
Muscle re-education. .
. Increasing local blood circulation.
Maintaining or increasing range of motion .
. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (SE-300 only).

For the SE-200 and SE-300 in muscle stimulation mode, the lowest three intensity settings may not provide effective muscle contractions to achieve the indications for use, especially when applied to large muscles or muscle groups. These settings are provided so that the intensity may be ramped up slowly for improved user comfort.

Device Description

The MedRelief SE Series™ provides a selection of both high-level and subthreshold electrotherapeutic modes in a compact, lightweight and userfriendly package. "Subthreshold" as used here means electrical stimulation not strong enough to cause nerve depolarization or muscle contraction, but still active at a cellular level, as in microcurrent TENS. Healthonics' proprietary version of subthreshold stimulation has been named Structured Energy™

Devices in the MedRelief SE Series™ provide combinations of these stimulation modes as follows:

Modelnumber	Includes: musclestimulation	interferentialstimulation	StructuredEnergyTM	Controls
SE-300	X	X	X	Rotary
SE-200	X*	X*	X	Rotary
SE-100	--	--	X	Rotary
SE-50	--	--	X	Recessed

- Output provided over reduced intensity range.

Models SE-200™ and SE-300™ provide all three stimulation modes, while Models SE-50™ and SE-100™ are miniaturized, single-mode Structured Eneray™-only versions. All devices are completely powered by 9-volt batteries, without provisions for line power or AC adapters. All devices are single-channel only.

All SE Series ™ devices produce trains of brief electrical pulses which are applied to the body through self-adhesive electrodes placed on the skin. Pulses recur at a nominal 4150 Hz and may be either 30 microseconds or 120 microseconds long. These pulses form a carrier wave which may then be modulated by one of three different envelopes, yielding respectively Structured Energy™, muscle stimulation, or premodulated interferential stimulation. Envelope frequencies range from 0.25 Hz to 130 Hz, depending on the mode being used.

All functions for a particular mode are preset, and accessed through a single rotary switch which also turns the device on and off. In the SE-200™ and SE-300™, a second rotary switch provides intensity control. In the SE-100™, all control functions are integrated into a single rotary switch, while in the SE-50™ this switch is replaced by two recessed, miniature slide switches.

While the MedRelief SE Series™ incorporates some ancillary digital components such as frequency dividers, its primary functioning is analog, with all digital functions hard-wired. Since there is no microprocessor, no software is needed.

AI/ML Overview

The provided text describes a 510(k) summary for the MedRelief SE Series™ (models SE-50, SE-100, SE-200, and SE-300), which are electrotherapeutic devices. The document explicitly focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies of the device itself.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from this 510(k) summary. The document does not describe a study involving human readers or standalone algorithm performance.

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) submission process for these types of devices relies on demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" here are implicitly related to meeting the functional and safety characteristics of the predicate devices.

The document states:

"Both new and predicate devices employ electronic circuitry to produce electrical output waveforms at closely comparable voltage and current levels and with closely comparable waveforms and timing."
"The MedRelief SE Series™ is primarily analog, with some hard-wired digital functions but no microprocessor and thus no software."

F. TESTING outlines the types of testing performed to support the 510(k) submission, indicating conformance to standards and guidance documents rather than specific, measurable performance metrics for clinical efficacy.

Acceptance Criteria	Reported Device Performance (as inferred from substantial equivalence)
Electrical output waveforms (voltage, current, timing) comparable to predicate devices	Device produces electrical output waveforms at "closely comparable voltage and current levels and with closely comparable waveforms and timing" to predicate devices.
Compliance with UL-2601 for Electrical Safety	Designed to comply with UL-2601; planned testing by an independent lab before marketing.
Compliance with EN 60601-1-2 for Electromagnetic Compatibility (unless exempt)	Designed to comply with EN 60601-1-2. Claims exemption from specific testing as no compatibility claims are made and output doesn't exceed muscle stimulation levels.
Conformance with ANSI/AAMI NS4-1985	Designed to comply with applicable requirements of ANSI/AAMI NS4-1985, supported by performance testing.
Adherence to "Guidance Document for Powered Muscle Stimulator 510(k)'s"	Performance testing carried out to address points in the FDA guidance document dated June 9, 1999.

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

This information is not applicable/provided. The document describes technical and safety testing of the device itself (hardware characteristics and compliance with standards), not a study involving a test set of data with clinical outcomes or performance against a specified ground truth.

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

This information is not applicable/provided. As above, there is no mention of a test set with ground truth established by experts.

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

This information is not applicable/provided. No adjudication method is mentioned as there is no test set or expert assessment 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

This is not applicable. The device (MedRelief SE Series™) is an electrotherapeutic stimulator, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This is not applicable. The device is an analog electrotherapeutic stimulator and does not contain an algorithm in the sense of AI or image processing. The document explicitly states: "Since there is no microprocessor, no software is needed."

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

This information is not applicable/provided in the context of clinical performance data. The "ground truth" for this submission refers to compliance with established engineering standards and functional specifications of predicate devices.

8. The sample size for the training set

This information is not applicable/provided. No "training set" is mentioned as it's not an AI/machine learning device.

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

This information is not applicable/provided. No training set is mentioned.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the MedRelief SE Series™ to existing predicate devices based on technological characteristics, intended use, and compliance with general safety and performance standards. It does not contain clinical study data, performance metrics against a defined "acceptance criteria" for accuracy or efficacy, or information on AI/machine learning components, human reader studies, or training/test sets.

Summary

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OCT 1 0 2003

510(k) SUMMARY.

MedRelief SE ("Structured Energy") Series (consisting of models SE-50, SE-100, SE-200 and SE-300)

Common/Classification Names: Microcurrent TENS Device, 21 CFR 882.5890 Interferential stimulator. 21 CFR 890.5850 Powered muscle stimulator, 21 CFR 890.5850

Healthonics, Inc. 903 Main Street South New Ellenton, SC 29809 Establishment Registration #1067052

Contact: James W. Kronberg Prepared: March 27, 2003

A. LEGALLY MARKETED PREDICATE DEVICES.

Devices in the MedRelief SE Series™ are substantially equivalent: (1) in powered muscle stimulation functions to the Microstim J-1304D, made by Nisha Communications Industries, Light Industrial Area, Jodhpur 342003 India, which was cleared for marketing by the FDA on July 13, 1998 as K980040; (2) in interferential stimulation functions to the IF-II Model 7200, made by Medical Devices, Inc., 833 Third Street Southwest, St. Paul, MN 55112-3483, which was cleared for marketing by the FDA on November 6, 1992 as K923914: and. (3) in microcurrent TENS stimulation functions to the original MedRelief device, made by Healthonics, Inc., 903 Main Street South, New Ellenton, SC 29803, which was cleared for marketing by the FDA on Feb. 21. 2001 as K003507. and to the Home Microcurrent HMC, also made by Medical Devices, Inc., which was cleared for marketing by the FDA on March 14, 1994 as K935132.

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B. DEVICE DESCRIPTION.

Devices in the MedRelief SE Series™ provide combinations of these stimulation modes as follows:

Modelnumber	Includes: musclestimulation	interferentialstimulation	StructuredEnergyTM	Controls
SE-300	X	X	X	Rotary
SE-200	X*	X*	X	Rotary
SE-100	--	--	X	Rotary
SE-50	--	--	X	Recessed

- Output provided over reduced intensity range.

While the MedRelief SE Series™ incorporates some ancillary digital components such as frequency dividers, its primary functioning is analog, with all

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digital functions hard-wired. Since there is no microprocessor, no software is needed.

C. INTENDED USE.

Since the MedRelief SE Series™ is a family of devices with differing functions, only those indications which the FDA has traditionally approved for the corresponding device types are sought.

For the SE-50™ and SE-100™, which include only subthreshold stimulation substantially equivalent to subthreshold TENS devices previously cleared by the FDA, the indications sought are:

- Relief of chronic intractable pain.
- Adjunctive treatment of post-surgical or post-traumatic acute pain.

For the SE-200™ and SE-300™, which include powered muscle stimulation as well as interferential and subthreshold stimulation, the following additional indications are sought:

- Relaxation of muscle spasms.
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Increasing local blood circulation
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

D. SUBSTANTIAL EQUIVALENCE SUMMARY.

The MedRelief SE Series™ is a family of medical devices, having the same indications for use, target populations, and technological characteristics as the legally marketed predicate devices. This premarket notification has described the characteristics of the MedRelief SE Series™ in sufficient detail to assure substantial equivalence.

E. TECHNOLOGICAL CHARACTERISTICS.

Both new and predicate devices employ electronic circuitry to produce electrical output waveforms at closely comparable voltage and current levels and with closely comparable waveforms and timing. The MedRelief SE Series™ is primarily analog, with some hard-wired digital functions but no microprocessor and thus no software.

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F. TESTING.

Healthonics has carried out design and performance testing to address the following issues:

(1) Performance testing for the purpose of addressing the points in the FDA guidance document, "Guidance Document for Powered Muscle Stimulator 510(k)'s," dated June 9, 1999.

(2) Electrical safety. The SE Series™ was designed to comply with UL-2601 and will be tested to this standard by an independent test laboratory before marketing.

(3) Electromagnetic compatibility. The SE Series™ was designed to comply with EN 60601-1-2, May 1993. However, the FDA guidance document exempts powered muscle stimulators from compatibility requirements unless specific claims of compatibility are made. Since Healthonics makes no such claims, and since no other output mode exceeds muscle stimulation in voltage, current or power. Healthonics believes that the SE Series™ is also exempt from this requirement.

(4) Conformance to NS4-1985. The SE Series™ was designed to comply with applicable requirements of ANSI/AAMI NS4-1985, as supported by performance testing.

G. CONCLUSIONS.

In summary, this pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food, Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Mr. James W. Kronberg Chief Engineer Healthonics, Inc. 903 Main Street South New Ellenton, SC 29809

Re: K030998

Trade/Device Name: MedRelief SE ("Structured Energy") Series™, Models SE-50, SE-100, SE-200 and SE-300 Regulation Number: 21 CFR 890.5850 and 21 CFR 882.5890 Regulation Name: Powered muscle stimulator and Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: IPF, GZJ, LIH Dated: August 4, 2003 Received: August 5, 2003

Dear Mr. Kronberg:

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

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Page 2 - Mr. James W. Kronberg

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 Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

for Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE.

510(k) number (if known) K030998

Device Name: MedRelief SE ("Structured Energy") Series, consisting of model numbers SE-50, SE-100, SE-200 and SE-300.

Indications for Use:

The MedRelief SE-50 and SE-100. and the MedRelief SE-200 and SE-300 in subthreshold and interferential modes, are intended for the following indications:

Relief of chronic intractable pain. .
Adjunctive treatment of post-surgical or post-traumatic acute pain. .

The MedRelief SE-200 and SE-300 in muscle stimulation mode are intended for the following indications:

Relaxation of muscle spasms. ●
Prevention or retardation of disuse atrophy. .
Muscle re-education. .
. Increasing local blood circulation.
Maintaining or increasing range of motion .
. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (SE-300 only).

(Please do not write below this line - continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) 510(k) (gmbs: --Over The Counter Use

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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).