Relief of chronic intractable pain. .
Adjunctive treatment of post-surgical or post-traumatic acute pain. .
Adjunctive therapy in reducing the level of pain associated with osteoarthritis of the ● knee.
Adjunctive therapy in reducing the level of pain from rheumatoid arthritis of the hand. .

Device Description

The MedRelief" ST Series™, consisting of models ST-100, ST-150, ST-200 and ST-300, is designed to provide subthreshold electrical stimulation for acute and chronic pain, including pain, including pain from osteoarthritis and rheumatoid arthritis, in a single compact, lightweight and user-friendly package. "Subthreshold" stimulation does not normally cause sensation or muscle contraction, but acts at a cellular level to relieve pain.

Each device in the ST Series is comprised of the following main components.

A power section consisting of battery, switch, test and conditioning components; .
A dosing timer, initialized at power-on and providing a choice of treatment times; .
A control oscillator, providing pulse-burst timing; .
A pulse oscillator, providing timing for individual pulses; and .
An output section, providing filtering, DC blocking and intensity control.

While some components are digital, all functions are hard-wired and there is no microprocessor or software used. Output is by means of lead wires and skin-contact electrodes already commercially available and legally sold by others.

The member devices in the ST Series™ differ only in the complexity of their controls and number of physician or user options which each model offers.

AI/ML Overview

The provided document (K060669) is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called the MedRelief ST Series. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on detailed clinical study results and acceptance criteria derived from them.

Therefore, the document does not contain the information required to fully answer the request, particularly regarding specific acceptance criteria for device performance, outcomes of a study proving those criteria were met, sample sizes, expert qualifications, or ground truth establishment.

However, based on the comparative tables, we can infer that the general acceptance criteria for the MedRelief ST Series are substantial equivalence in technological characteristics and intended use to the predicate devices. The study proving this, in the context of a 510(k), is the comparison of the proposed device's characteristics to those of the predicate devices.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied to be that the proposed device's characteristics fall within acceptable limits or are the "same as" the predicate devices. The "reported device performance" is essentially the detailed description of the proposed device's characteristics.

Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (MedRelief ST Series)
Intended Use (Indications)	ST-100: Relief of chronic intractable pain; Adjunctive treatment of post-surgical or post-traumatic acute pain. ST-150, ST-200, ST-300: Relief of chronic intractable pain; Adjunctive treatment of post-surgical or post-traumatic acute pain; Adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee; Adjunctive therapy in reducing the level of pain and stiffness associated with pain from rheumatoid arthritis of the hand. (Stated to be the same as predicate devices for respective indications)
Number of Output Modes (Subthreshold TENS)	One: Subthreshold TENS (Same as predicates)
Number of Output Channels	One (ST-100, ST-150); Two (ST-200); Four (ST-300). (Predicate 1 has one; Predicate 2 has one or two versions)
Pulse Shape	Rectangular to exponential, depending on pulse length and charge balancing time chosen (Same as Predicate 1, different but biphasic for Predicate 2)
Mono- or Biphasic Output	Biphasic (Same as Predicate 1; Predicate 2's claimed monophasic was measured by Healthonics as biphasic - Note 1)
Maximum Instantaneous Current	8.62 mA (Same as Predicate 1; Lower than Predicate 2's 24 mA)
Maximum Time Averaged Current	2.27 mA (2.71 mA, Note 2) (Same as Predicate 1's 2.27 mA; Higher than Predicate 2's 2 mA)
Maximum Phase Charge	12.4 µC at 100 Hz; 1.87 µC at 700 Hz (Note 2) (Predicate 1: 1.87 µC at 700 Hz; Predicate 2: 20 µC at 100 Hz). Values show variability across models and frequencies but are presented in comparison to predicates.
Maximum Current Density at Electrode	0.41 mA/sq.cm. (Note 2) (Same as Predicate 1's 0.41 mA/sq.cm.; Much higher than Predicate 2's 0.14 mA/sq.cm.)
Maximum Power Density at Electrode	0.133 mW/sq.cm. (Note 2) (Same as Predicate 1's 0.133 mW/sq.cm.; Much lower than Predicate 2's 0.83 mW/sq.cm.)
Regulated Current or Voltage?	Regulated current (Same as Predicate 1; Different from Predicate 2's regulated voltage)
Software/Firmware/Microprocessor Control?	No (Same as Predicate 1 and Predicate 2 Version A; Different from Predicate 2 Version B which has it)
Housing Materials	Flame-retardant ABS plastic (Same as Predicate 1; Different from Predicate 2's Cycolac plastic)

The "study" proving these "criteria" are met is essentially the technical comparison presented in the 510(k) submission, where the characteristics of the MedRelief ST series are directly compared against those of the predicate devices (Healthonics MedRelief SE-50 and Bionicare Model BIO-1000). The FDA's issuance of the 510(k) clearance signifies their agreement that the device is substantially equivalent based on this comparison.

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

This information is not provided in the 510(k) summary. 510(k) submissions for TENS devices demonstrating substantial equivalence rarely require clinical studies with human test sets, especially if the new device is technologically similar to previously cleared devices. The "test set" here would implicitly be the technical specifications and performance measurements detailed in the tables, which were likely derived from in-house engineering tests and comparisons.

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)

This information is not provided. As no clinical study is detailed, the concept of establishing ground truth by medical experts in this context is not applicable. The "ground truth" for this submission would be the verifiable specifications and performance of the device and its predicates.

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

This information is not provided. Not applicable in the context of a technical comparison for substantial equivalence.

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

No, a multi-reader multi-case comparative effectiveness study was not done. This is a TENS device, and the submission is a 510(k) for substantial equivalence, not an AI or imaging device requiring MRMC studies.

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

No, a standalone algorithm performance study was not done. The device does not contain a microprocessor or software (except for Version B of one predicate), therefore, it does not rely on algorithms in the way modern AI devices do. Its performance is based on its hardware characteristics.

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

The "ground truth" for this 510(k) submission consists of technical specifications and performance measurements of both the proposed device and its predicate devices (some measured by Healthonics from predicate devices, some from predicate's 510(k) information). For example, electrical output measurements, timing values, pulse characteristics, current/power densities, and material compositions.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of this device and submission type.

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

This information is not applicable/not provided. There is no "training set" for this device.

Summary

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K060669

Applicant: Healthonics, Inc. MedRelief®® ST Series Microcurrent TENS Traditional 510(k) Premarket Notification

Page 1:4

OCT 1 3 2006 Biophysics Health Co

510(k) Summary:

510(k) Owner:	Healthonics, Inc.903 Main Street SouthNew Ellenton, SC 29803
Contact Person:	James W. KronbergChief EngineerPhone 803-652-2354Fax 775-251-0023
Date Prepared:	March 10, 2006 - Revised September 13, 2006
Device Name:	MedRelief ST ("Sub-Threshold") Series, consistingof models ST-100, ST-150, ST-200 and ST-300.
Common or Usual Name:	TENS device.
Classification Name:	Transcutaneous Electrical Nerve Stimulator for PainRelief. 21 CFR 882.5890, Class II, Product Code84GZJ (prescription) or Stimulator, Electrical,Transcutaneous, for Arthritis. 21 CFR 882.5890,Class II, Product Code NYN (prescription).
Predicate Devices:	Healthonics MedRelief® SE-50 for acute and chronicpain indications (K030998).Bionicare Model BIO-1000 for osteoarthritis(K030332) and rheumatoid arthritis (K983228)indications.

Description of the Device:

Each device in the ST Series is comprised of the following main components.

A power section consisting of battery, switch, test and conditioning components; .
A dosing timer, initialized at power-on and providing a choice of treatment times; .
A control oscillator, providing pulse-burst timing; .
A pulse oscillator, providing timing for individual pulses; and .
An output section, providing filtering, DC blocking and intensity control.

The member devices in the ST Series™ differ only in the complexity of their controls and number of physician or user options which each model offers.

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page 2:4

Indications and Intended Use:

. Relief of chronic intractable pain. (All modelse) ;
. Adjunctive treatment of post-surgical or post-traumatic acute pain. {{{#=====================================================================================================
Adjunctive therapy in reducing the level of pain and symptoms associated with . osteoarthritis of the knee. (ST-150, ST-200 and ST-300 and ST-300 and ST-300 coment
. Adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand. (ST-150, ST-200 and ST-300 and ST-300 ember

The indications are the same as for the predicate devices listed. All units are for prescription use only. The ST-100 is a simplified unit meant for home use, with one output channel and a minimal set of signal options, closely similar to the SE-50 predicate device. Other devices in the ST Series™ are meant for a wider range of indications by including a signal modeled on that of the Bionicare BIO-1000 predicate device. The ST-150 is otherwise identical with the ST-100. The ST-200 offers two output channels and more user options. The ST-300 offers four channels, even more options, and is meant for use in a clinical setting only.

Technological Characteristics:

The technological characteristics of the MedRelief® ST Series™ are the same as those of the predicate devices. Each device is battery-powered with no provisions for line power or AC adapters. Each uses solid-state electronics to produce trains of subthreshold electrical pulses, at frequencies within the human audible range (~20 Hz to ~20 KHz), which are applied to the body through self-adhesive or gelled electrodes placed on the skin. Pulses have zero net charge and may be applied either continuously, or divided into pulse bursts alternating with quiet periods. All signal characteristics comply with the safety requirements of AAMI NS4.

Comparison of Features of MedRelief® ST Series™ Models

(s) - user switch selected. (c) - user adjustable through continuous range.

Characteristic or Feature	ST-100	ST-150	ST-200	ST-300
Intended use	Intractable chronic, postsurgical / posttraumatic acute and arthritis-related pain.
Intended sale	Prescription only
Number of outputchannels	1	1	2	4
Pulse frequency	700, 1800 or4150 Hz (s)	100, 700 or4150 Hz (s)	100, 230, 700,1800, 4150Hz or 12 KHz (s)	100 Hz to 20KHz (c)
Pulse (short phase) length	1/7 of long phase or 20 microseconds, whichever is greater
Burst frequency	15 Hz in pulse burst mode; N/A in continuous mode.
Burst duty cycle	15% or 100%* (s)	5% up to 100%* (c)
Timer	None (runs whenever turned on)	30 min., 8 hrs or cont. (s)
Dimensions, in.	2.5 x 2.1 x 0.63	3.5 x 2.5 x 1	7 x 5 x 2.5
Weight including battery	1.7 oz.	2.5 oz.	8 oz.
Charger, AC cord oradapter?	None

Burst duty cycle of 100% = continuous operation.

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y 3. 4

Comparison of General and Technical Characteristics to Predicates.

Electrical output measurements assume a 500-ohm load. Timing values cited below are accurate to ±20% or 10 microseconds, whichever is larger. Other cited values are accurate to ±20% unless otherwise stated.

For conciseness, (10), (15), (20) and (30) refer to the ST-100, ST-150, ST-200 and ST-300 respectively. "Same" plus one or more of these labels in a Predicate column means "same as in the indicated ST Series™ device(s)," while without a label it means "same for all." See also notes 1-3 at the bottom of the table.

Unit Characteristic	Proposed Device	Predicate #1	Predicate #2
Device name and model	MedRelief® ST Series(ST-100, ST-150, ST-200 and ST-300)	MedRelief® SE-50(in SE Series).	BioniCare®Stimulator, ModelBIO-1000™
Manufacturer	Healthonics, Inc.903 Main Street SouthNew Ellenton, SC 29803	Same.	BioniCare MedicalTechnologies, Inc.47 R. Loveton CircleSparks, MD 21152
510(k) number	To be assigned	K030998	K030332, K983228
Procode	GZJ, NYN	GZJ	NYN
Intended Use(indications; abbreviated,see full list above.)	1. Chronic intractable pain.2. Post-surgical/post-traumatic acutepain.3. Pain/symptoms from osteoarthritisof the knee.4. Pain/stiffness from rheumatoidarthritis of the hand.	Same as #1 and #2for proposed device.	Same as #3 and #4for proposed device
Number of outputmodes	One: subthresholdTENS.	Same.	Same.
Number of outputchannels.	One (10, 15), two (20), or four (30).	One.	Version A: one.Version B: two.
Pulse shape	Rectangular to exponential,depending on pulse length andcharge balancing time chosen.	Same.	One phaseexponential, otherphase rectangular.
Mono- or biphasic	Biphasic	Biphasic	Biphasic (note 1)
Maximum instantaneouscurrent	8.62 mA	Same	24 mA
Maximum time averagedcurrent	2.27 mA (2.71 mA, note 2)	Same	2 mA
Maximum phase charge	12.4 µC at 100 Hz;1.87 µC at 700 Hz (note 2)	1.87 µC at 700 Hz(note 2)	20 µC at 100 Hz
Maximum current densityat electrode	0.41 mA/sq.cm. (note 2)	Same	0.14 mA/sq.cm.(note 3)
Maximum power densityat electrode	0.133 mW/sq.cm. (note 2)	Same	0.83 mW/sq.cm.(note 3)
Regulated current orregulated voltage?	Regulated current.	Same.	Regulated voltage.
Software/ firmware//microprocessor control?	No	No	No in Version A; yesin Version B.
Housing materials andconstruction.	Flame-retardant ABS plastic.	Same.	Flame-retardantCycolac plastic
Accessories:1. Electrodes.	Pregelled reusable electrode,25 cm² gel area, with "pigtail" wireconnection. For 100 Hz use (15, 20,30), same but with 175 cm² gel area.	Pregelled reusableelectrode, 25 cm² gelarea, with "pigtail"wire connection.	BioniCare specialdesign, metal mesh,170-176 cm² gel-coated area.
2. Conductivemedium (gel)	None	None	Spectra 360

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Applicant: Healthonics, Inc.

x 4:4

3. Electrode leadwires.	2 mm pin joined to 2mm socket byflexible wire	Same.	Semicustom wires,snap connectors
4. Batteries.	9V lithium batteries: miniaturesemicustom (10, 15, 20) ; standardrectangular (30).	Same (10, 15, 20)	Self-containedrechargeable battery.
5. Battery charger,if used.	None.	None.	Plug-in walltransformer type
Note 1. BioniCare claims monophasic pulses, but Healthonics scope measurements show the second phase is notcompletely suppressed so the BioniCare pulses are actually biphasic.Note 2: Taken under conservative worst-case conditions including any single-component failure.

Note 3. Healthonics measured from predicate device or calculated from information in predicate's 510(k).

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of three human profiles facing right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 2006

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

Re: K060669

Trade Name: MedRelief ST ("Sub-Threshold") Series consisting of model numbers ST-100. ST-150, ST-200, and ST-300 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, NYN Dated: September 13, 2006 Received: September 14, 2006

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 Pegister.

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 not mour 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 100-1050.

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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 (240) 276-0120. 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 vours.

Mark N. Melkonian

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

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Indications for Use

510(k) number (if known): ___K060669

Device Name: MedRelief ST ("Sub-Threshold") Series, consisting of model numbers ST-100, ST-150, ST-200 and ST-300.

Indications for Use.

For Prescription Use Model SE-100:

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

For Prescription Use Models ST-150, ST-200 and ST-300:

Relief of chronic intractable pain. .
Adjunctive treatment of post-surgical or post-traumatic acute pain. .
Adjunctive therapy in reducing the level of pain associated with osteoarthritis of the ● knee.
Adjunctive therapy in reducing the level of pain from rheumatoid arthritis of the hand. .

Prescription Use(21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart D)
--------------------------------------------	--------	------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	L060669
---------------	---------

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).