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

Device Description

The Ttech NMES is a dual channel NMES device that produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with their lead wires, a battery (9 volt), carrying case, and instructions for use make up the Ttech NMES system.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Ttech NMES device. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain specific acceptance criteria or an analytical study that proves the device meets such criteria in the way typically found for AI/ML-based medical devices with performance metrics like sensitivity, specificity, etc.

Instead, the document focuses on bench testing to demonstrate safety and performance equivalence to existing predicate devices. The conclusion explicitly states: "Bench testing raised no additional patient safety or performance issues so clinical testing was not indicated." This implies equivalence was established through non-clinical means.

Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable or present in this document.

Here's an attempt to answer the questions based on the provided text, while highlighting what is not present:

Acceptance Criteria and Study Details for Ttech NMES

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating that the Ttech NMES device performs "Good" in critical functions like "Current pulse regulation" and that its output parameters are within a range comparable to the predicate devices. The study performed was primarily bench testing to ensure safety and performance equivalence, rather than a clinical trial measuring specific performance metrics against pre-defined acceptance thresholds.

Feature / Performance Metric	Acceptance Criteria (Implicitly based on Predicate Devices)	Reported Device Performance (Ttech NMES)	Predicate Device 1 (EMPI Focus) Performance	Predicate Device 2 (RESTIM) Performance
Current pulse regulation	Good	Good	Good	Good
Maximum output current	Comparable to or within acceptable range of predicates	93mA	60mA	90mA
Load range	Comparable to or within acceptable range of predicates	8ohm to open circuit	8ohm to 10Kohm	8ohm to open circuit
Maximum output voltage	Comparable to or within acceptable range of predicates	+100V	+120V	+55V
Maximum phase charge	Comparable to or within acceptable range of predicates	21uC	3.12 uC	2.73 uC
Peak current density	Comparable to or within acceptable range of predicates	0.125MAKm²	7.92mA/cm²	12.45 mA/cm²
Maximum Power Density	Comparable to or within acceptable range of predicates	.0058W/cm²	4.09X10-5W/cm²	4.29X10-6W/cm²
Patient Lead Safety	Compliance with 21 CFR 898 (Pass/Fail)	Testing Completed (Implied Pass)	N/A - Not explicitly stated for predicates	N/A - Not explicitly stated for predicates
Open/Short Circuit	Functional (Pass/Fail)	Testing Completed (Implied Pass)	N/A	N/A
Temperature Endurance	Functional (Pass/Fail)	Testing Completed (Implied Pass)	N/A	N/A
Incorrect battery install.	Functional (Pass/Fail)	Testing Completed (Implied Pass)	N/A	N/A
Vibration Test	Functional (Pass/Fail)	Testing Completed (Implied Pass)	N/A	N/A
Mechanical Shock Test	Functional (Pass/Fail)	Testing Completed (Implied Pass)	N/A	N/A
Humidity endurance test	Functional (Pass/Fail)	Testing Completed (Implied Pass)	N/A	N/A
Water immersion endurance	Functional (Pass/Fail)	Testing Completed (Implied Pass)	N/A	N/A

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

Not applicable. The document describes non-clinical "bench testing" and does not refer to a "test set" in the context of patient data for performance evaluation. The data provenance would be laboratory testing in a controlled environment.

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

Not applicable. No expert ground truth on patient data was established, as no clinical testing was performed or deemed necessary.

4. Adjudication method for the test set

Not applicable. No test set involving human interpretation and adjudication was used.

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 powered muscle stimulator (NMES), not an AI/ML-based diagnostic or assistive technology for human readers. No MRMC study was performed.

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

Not applicable. This device is electro-mechanical, not an algorithm.

7. The type of ground truth used

For the safety and performance features, the "ground truth" was established through engineering standards and specifications (e.g., 21 CFR 898 for patient lead safety) and direct comparison of electrical output parameters against established values for predicate devices. There is no biological or clinical "ground truth" like pathology or outcomes data mentioned in this submission.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. See point 8.

Summary

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Exhibit #1

Page 1 of 4

510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

2013768 The assigned 5l0(k) number is:_

Submitter's Identification:

Theratech, Inc. 1109 Myatt Blvd. Madison, TN 37115 FDA Registration: To be applied for Phone: 615-865-4000 Fax: 800-485-2626

Date Summary Prepared:

November 6, 2001

Name of the Device:

Trade Name: Ttech NMES a.
b. Common Name or Classification Name of Device: Powered Muscle Stimulator/Neuromuscular Stimulation (NMES) System

The Physical Medicine Device Panel (DGRD) has classified this device as Class II. 21 CFR Part 890.5850, Product Code 89 IPF.

Predicate Device Information:

NMES:

K951951, EMPI Focus Powered Muscle Stimulator (NMES), EMPI, Inc., 5255 East River Road, Fridley, MN 55421; K003596, RESTIM, Smith and Nephew, Inc. N104 W13400 Donges Bay Rd., Germantown, WI 53022.

Electrode Leads:

K002874. Well-TENS (various model of TENS). Well-Life Healthcare, Inc., Ltd., Taichaung, Taiwan. (the leads are the same for the NMES as for the TENS)

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Electrodes:

Wandy Rubber Industrial Co., Ltd. Self-Adhesive Neurostimulation Electrodes, K002219

Device Description: The Ttech NMES is a dual channel NMES device that produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with their lead wires, a battery (9 volt), carrying case, and instructions for use make up the Ttech NMES system.

Intended Use:

As an NMES device, the Ttech NMES is indicated for the following conditions:

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

Comparison to Predicate Devices:

See attached comparison chart

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:

In addition to performance testing for comparison purposes, the following testing was also completed:

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Page 3 of 4

Patient Lead Safety Testing (21 CFR 898) Test for open /short circuit performance Temperature endurance test Incorrect battery installation test Vibration Test Mechanical Shock Test Humidity endurance test Water immersion endurance test

Discussion of Clinical Tests Performed:

Bench testing raised no additional patient safety or performance issues so clinical testing was not indicated

Conclusions:

The Ttech NMES has the same intended use and technological characteristics as the predicates. No new questions of safety or effectivness have been raised, therefore the Ttech NMES is substantially equivilent to the predicates.

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Manufactures	Empi	Smith & Nephew	Theratech
Model Number	Empi FOCUS	RESTIM	Ttech NMES
510(k) Number	K951951	K003596	To be assigned
Equipment Classification	Hand held. InternallyPowered	Hand held. Internallypowered	Hand held. Internallypowered
Output Modality	programmable pulse on/offtimes and biphasic.	Fixed, Single.rechargeable NiMN 8.4V	Fixed. Single
Power source	Primary cell, 9V PP3 battery	PP3 battery	9 Volt Battery
Recharge Regime	Replace battery.	In situ.	Replace battery
Patient connection	Type BF. Isolated.	Type BF. Isolated. Nopatient connection ispossible during recharge.	Type BF. Isolated
Current pulse regulation	Good.	Good	Good
Maximum output current	60mA	90mA	93mA
Load range	8ohm to 10Kohm	8ohm to open circuit	8ohm to open circuit
Maximum ouput voltage	+120V	+55V	+100V
Maximum phase charge	3.12 uC.	2.73 uC.	21uC
Peak current density*	7.92mA/cm2	12.45 mA/cm²	0.125MAKm²
Maximum Power Density**	4.09X10-5W/cm2	4.29X10-6W/cm2	.0058W/cm²
Pulse shape	Symmetric or asymmetricbiphasic.	Asymmetric Biphasic	Asymmetrical Biphasic
Pulse pattern	Simple. Programmablerepetition rate.	Complex. One secondrepetition rate	Complex
User set-up method	Multiple rotary dials.	Two switches for intensityincrease/decrease	Multiple Rotary Dials
User display	None.	2 digit LCD plus LED	none
Low battery detect	Partial	Yes	Partial
Connection error indication	None.	Yes (open cct)	None
Treatement time	Selectable between 15 minsor continuous.	1 hour fixed	15min - 30min orContinuous
Pulse width	Nominal 260 usec. Useradjustable	Nominal 250usec. Can beset between 50 and350usec by the user.	250usec (fixed)

ﺮ ﺍ

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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized depiction of an eagle with three human profiles incorporated into its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2002 JUL

Theratech, Inc. C/o Ms. Susan Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K013768

Trade/Device Name: Ttech NMES Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: April 5, 2002 Received: April 9, 2002

Dear Ms. Goldstein-Falk:

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. This letter will allow you to begin marketing your device as described in your Section 510(k)

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Page 2 - Ms. Goldstein-Falk

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Styp Rhodes

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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Exhibit B

Page 1 of of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Theratech, Inc. Ttech NMES

Indications For Use:

As an NMES device, the Ttech NMES is indicated for the following conditions:

Relaxation of muscle spasms 1.
1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
Muscle re-education 4.
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
1. Maintaining or increasing range of motion

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
---------------------

Division of General, Restorative and Neurological Devices

510(k) Number	K013768
---------------	---------

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use × (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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).