To determine the activation timing of muscles.
a) retraining of muscle activation
b) coordination of muscle activation
An indication of the force produced by muscle
a) control and maintenance of muscle contractions
For use in relaxation training and muscle re-education.

Device Description

The EMG Retrainer is a device used to measure the bioelectrical signals produced by muscle activity. The main display will register activity and display the quantitative measurement with an analog bar display. Targets of muscle activity may be stored (utilizing audible signals on demand) configurable for activity that is within established limits or exceeding those limits depending on user preference. The EMG Retrainer also contains an auto-ranging function which eliminates manual scale adjustments unless that is the preference. The auto-ranging feature as well as the targeting function are not available on the other models and will be quite useful to the healthcare professional.

AI/ML Overview

The provided text is a 510(k) summary for the Chattanooga Group, Inc. EMG Retrainer, dated September 26, 1997. It describes the device, its intended use, and comparative specifications against predicate devices to establish substantial equivalence.

Based on the information provided in the document:

Table of acceptance criteria and the reported device performance:

The document does not explicitly state "acceptance criteria" as a set of quantified performance targets that the EMG Retrainer needed to meet for a specific study. Instead, it presents comparative specifications to demonstrate substantial equivalence to previously cleared predicate devices. The device performance is implicitly considered acceptable if it meets or exceeds the specifications of the predicate devices for key technical features, or if differences do not raise new questions of safety or effectiveness.

Feature	Predicate Devices (VERIMED Myoexerciser II, Myotrac 4001, Prometheus Pathway MR20)	Chattanooga Single & Dual EMG Retrainer Performance
Product Name	Myoexerciser II, 4001, MR20	EMG
Pickup Config	Individual electrodes, Triangular Pattern, DeLuca in-line or Proprietary	Triangular or individual electrodes
Active Head	No, Yes, Yes (for Proprietary)	No
Input Impedance	>10M ohm, 1,000,000 M ohm, unknown	1,000,000 M Ohm with 4pF
Input Noise	(Not specified for predicates)	<1uV RMS
Display Type	4 lines x 20/5 lines x 25 characters, 13 LED Dot Bar chart, 16 char LCD histograms/log output	Custom LCD, dual 25 Seg Bar Chart plus overflows, 3x7seg digit signal level per channel
Operator Controls	12 Membrane Buttons, Volume & Gain Knobs/Range Slide/Mode/On/Off, 6 Membrane Buttons	5 Silicone Keypad Buttons; On/Off; Up, Down, Select & OK
Channels	2, 1, 2	1 or 2
Frequency Ranges	25 to 1000Hz, 100 to 200Hz / 20 to 500Hz, 20 to 500 Hz	15Hz to 300Hz (12dB/Octave filter)
Buzzer	Yes	3 Tone
Output Voltage	Yes, Yes 0 to 2V, No (data by comms)	No
CMRR (50 Hz, 60 Hz)	140dB, >180 dB, unknown	>100dB
CMRR (over frequency)	120dB, >130 dB, >110 dB	>120dB
Input Ranges (rms)	8 ranges, 0.8 to 20/200/2000 uV, 1 to 800 uV true RMS	1uV to 2000uV Internal auto gain selection 8 Ranges
Electrode Wire	2 core + Screen, 2 core + Screen, 4 conductors	2 core + Screen
Earpiece	Yes, Yes 2.5mm Phono, Yes	Yes 2.5mm Phono
Threshold	Above & Below, Above & Below & Difference	Above, Below & At Target per channel
Threshold Features	N/A, Separate Hi/Lo indicating Leds	Bar Chart Dynamic Indication, set by manual, direct activity or % of activity
Threshold Lock	4 seconds then switch to deactivate, unknown	Yes, Dynamic Threshold Setting
Continuous Alarm	Yes, Varying pulse rates, Yes	Yes, Varying pulse rates
Stimulator	Yes, No, Isolated Relay	No
Historical Record	Yes, N/A, 32 Training Sessions	9 training sessions
Battery Type	9V	3V Using AA cells
Battery Compartment	Slide open	Slide open
Power Consumption	6 to 11 mA, unknown	10 mA w/ Management power (Carbon, Alkaline or Ni Cad)
Dimensions	85W140L30H, 61W112L28H, 1176938mm	81W84L40D
Weight	180g, 70 g+bat., 280g	150g
Pocket Clip	Yes	Yes

The document highlights that unique features of the EMG Retrainer not available on other models, such as auto-ranging and targeting function, "will be quite useful to the healthcare professional," implying an improvement over predicate devices.

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

The document does not describe a clinical "test set" or a clinical study with patients. The substantial equivalence determination is based on a comparison of device specifications and intended use against legally marketed predicate devices, not on a clinical performance study. Therefore, information on sample size, data provenance (country of origin, retrospective/prospective) for a test set is not applicable or provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The document establishes substantial equivalence through engineering and functional specifications comparison, not through a clinical study requiring expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set requiring adjudication is described.
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 MRMC study was done, as this submission predates widespread AI in medical devices and focuses on foundational EMG device functionality and substantial equivalence to existing devices. This device is not an AI-powered system, so the concept of improving human readers with AI assistance is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is a physical medical device (EMG Retrainer) and not an algorithm for standalone performance evaluation in the context of AI. The performance outlined is that of the hardware device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The ground truth for establishing substantial equivalence in this context is the FDA-cleared predicate devices and their established safety and effectiveness based on their specifications and intended uses.
The sample size for the training set:

Not applicable. There is no mention of machine learning or an algorithm requiring a training set in this 510(k) submission.
How the ground truth for the training set was established:

Not applicable. No training set is mentioned or implied.

Summary

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Image /page/0/Picture/2 description: The image shows the 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 a stylized eagle emblem, with three curved lines representing the eagle's body and wings. The emblem is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 1997

Mr. Joe Elrod Manager of Regulatory Affairs Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 37343-0489 Hixson, Tennessee

K972487 Re : EMG Retrainer Trade Name: Regulatory Class: II 84HCC Product Code: June 5, 1997 Dated: Received: July 2, 1997

Dear Mr. Elrod:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Joe Elrod

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Thomas J. Callahion

Thomas J. Callanan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972487

Device Name:	Chattonooga Group, Inc.
Indications For Use:	1. To determine the activation timing of muscles.a) retraining of muscle activationb) coordination of muscle activation2. An indication of the force produced by musclea) control and maintenance of muscle contractions3. For use in relaxation training and muscle re-education.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Atte Heif for DB Stillman

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K 972487

Over-The-Counter Use _________

Prescription Use X (Per 21 CFR 801.109)

{3}------------------------------------------------

K972487
Sept. 26, 1997
510(K) SUMMARY

CHATTANOOGA
GROUP, INC.

June 5, 1997 Date: Contact Person: Joe Elrod EMG Retrainer Product: Diagnostic Electromyograph Classification Name: Class II Classification:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Substantial Equivalence: The new device is a stand alone portable device for the measurement of muscle activity. It is similar to The Prometheus Group Pathway II Electromyography (510(k) K891732), Verimed Myoexerciser II (510(k) K892649), Reference Comparative and Thought Technology Myotrac (510(k) K915858). Specifications on page 2-2}.

System Description: The EMG Retrainer is a device used to measure the bioelectrical signals produced by muscle activity. The main display will register activity and display the quantitative measurement with an analog bar display. Targets of muscle activity may be stored (utilizing audible signals on demand) configurable for activity that is within established limits or exceeding those limits depending on user preference. The EMG Retrainer also contains an auto-ranging function which eliminates manual scale adjustments unless that is the preference. The auto-ranging feature as well as the targeting function are not available on the other models and will be quite useful to the healthcare professional.

Intended Use: The EMG Retrainer measures electrical activity of the muscle . Since the electrical activity of the muscle increases as the muscle tension increases and decreases as muscle tension decreases, EMG can provide information about the state of muscle tension.

Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 Hixson, TN 37343-0489 Phone: 423-870-2281 Fax: 423-874-0287

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COMPARATIVE SPECIFICATIONS

Feature	VERIMED	Myotrac	PrometheusPathway	ChattanoogaSingle & DualEMG
Product Name	Myoexerciser II	4001	MR20	EMG
Pickup Config	individual electrodes	Triangular Pattern	DeLuca in-lineor Proprietary	Triangular or individualelectrodes
Active Head	No	Yes	Yes for Proprietary	No
Input Imped.	>10M ohm	1,000,000 M ohm	unknown	1,000,000 M Ohm with 4pF
Input Noise				<1uV RMS
Display Type	4 lines x 20 characters5 lines x 25 characters	13 LED Dot Bar chart	16 char LCD histogramswith log output4 LED s	Custom LCD, dual 25 Seg BarChartplus overflows, 3 by 7seg digitsignal level per channel, plusvolume, & progr. Select digit
Operator Controls	12 Membrane Buttons	Volume & Gain KnobsRange Slide SwitchMode/On/Off switch	6 Membrane Buttons	5 Silicone Keypad Buttons;On/Off;Up, Down, Select & OK
Channels	2	1	2	1 or 2
Frequency Ranges	25 to 1000Hz	100 to 200Hz20 to 500Hz	20 to 500 Hz"no notch filter"	15Hz to 300Hz(12db/Octave filter)
Buzzer	yes	Yes	Yes	3 Tone
Output Voltage	yes	Yes 0 to 2V	No (data by comms)	No
CMRR50 Hz, 60 Hz	140dB	>180 dB	unknown	>100db
CMRRover frequency	120dB	>130 dB	>110 dB	>120db
Input Ranges(rms)	8 ranges	0.8 to 20uV0.8 to 200uV0.8 to 2000uV	1 to 800 uVtrue RMS	1uV to 2000uVInternal auto gain selection8 Ranges
Electrode Wire	2 core + Screen	2 core + Screen	4 conductors	2 core + Screen
Earpiece	yes	Yes, 2.5mm Phono8 to 32 Ohm	Yes	Yes2.5mm Phono
Threshold		Above & Below	Above & Below& Difference	Above, Below & At Target perchannel
ThresholdFeatures		N/A	Separate Hi/Lo indicatingLeds	Bar Chart Dynamic Indication,set by manual, direct activity or% of activity.
Threshold Lock		4 seconds then switch todeactivate	unknown	Yes, Dynamic ThresholdSetting
ContinuousAlarm	Yes, Varying pulse rates	Yes	unknown	Yes, Varying pulse rates
Stimulator	yes	No	Isolated Relay	No
Historical Record	yes	N/A	32 Training Sessions	9 training sessions
Battery Type	9V	9V	9V	3V Using AA cells
BatteryCompartment	Slide open	Slide open	Slide open	Slide open
PowerConsumption		6 to 11 mAAlkaline for 50 hrs	unknownBattery for 25Hrs	10 mA w/ Management powerCarbon, Alkaline or Ni Cad
Dimensions	85W140L30H	61W112L28H	1176938mm	81W84L40D
Weight	180g	70 g+bat.	280g	150g
Pocket Clip	Yes	Yes	Yes	Yes

ﺮ

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 1997

Mr. Joe Elrod Manager of Regulatory Affairs Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 Hixson, Tennessee 37343-0489

K972487 Re : EMG Retrainer Trade Name: Regulatory Class: II Product Code: 84HCC June 5, 1997 Dated: Received: July 2, 1997

Dear Mr. Elrod:

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

{6}------------------------------------------------

Page 2 - Mr. Joe Elrod

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Thomas J. Callahon

Thomas J. Callaman, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

510(k) Number (if known): K972487

Device Name:	Chattanooga Group, Inc.
Indications For Use:	1. To determine the activation timing of muscles.a) retraining of muscle activationb) coordination of muscle activation
	2. An indication of the force produced by musclea) control and maintenance of muscle contractions
	3. For use in relaxation training and muscle re-education.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for DB Tillman

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number 972487

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use_

Regulation Number and Section

§ 882.5050 Biofeedback device.

(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.