The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide a treatment in static, intermittent, progressive and cycling distraction forces to relieve pressures on micentifies that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices with the optional EMG (a.k.a. sEMG) biofeedback feature may be used to relieve peripheral radiation/sciatica and nain associated with:
➤ Protruding discs
➤ Bulging discs
➤ Herniated discs
➤ Degenerative disc disease
➤ Posterior facet syndrome
➤ Acute facet problems
➤ Radicular pain
➤ Prolapsed discs
➤ Spinal root impingement
➤ Hypomobility
➤ Degenerative joint disease
➤ Facet syndrome
➤ Compressions fractures
➤ Joint pain
➤ Discogenic pain

EMG (a.k.a. sEMG)
Determination of the activation magnitude and timing of muscles for:
a) retraining of muscle activation
b) coordination of muscle activation
Determination of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education

Device Description

The Chattanooga Group powered traction device consists of an electric traction treatment unit, and may be sold with the following: EMG (a.k.a. sEMG) biofeedback feature, Pull-Pattern intermittent traction preset feature, patient traction treatment table device, positioning bolster accessories, patient traction belt accessories, high volt pulsed electrotherapy device and miscellaneous traction devices and/ or accessories. The device is intended to be used in hospitals, physical therapy clinics and chiropractic clinics for treatment in static, intermittent, progressive, regressive and cyclic, distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). The device is restricted to sale by or on the order of a licensed physician or licensed practitioner.

The primary features of the Triton/ Tru-Trac/ TX/ Triton DTS Traction hardware are the traction unit (a.k.a. traction head), display screen, traction rope, mounting assembly and patient stop treatment switch.

The EMG biofeedback feature is used to detect muscle activation and relaxation for Frie ENC oferous traction therapy. The treating clinician determines the minimum muscle activation or minimum muscle relaxation threshold set point. This is done by utilizing the visual display. The intermittent traction reacts to these threshold settings and administers prescribed traction treatment. The Pull Pattern feature is a preset of intermittent traction settings, less the setting of traction force, less setting of traction time. Force and time parameters are determined by the treating clinician.

AI/ML Overview

The provided information does not describe a study that proves the device meets specific acceptance criteria in terms of performance metrics or clinical outcomes. Instead, it details the submission for 510(k) premarket notification for the Triton/ Tru-Trac/ TX/ Triton DTS Traction device, which primarily relies on demonstrating substantial equivalence to legally marketed predicate devices.

The acceptance criteria mentioned are related to compliance with recognized consensus standards for medical equipment safety and electromagnetic compatibility, rather than clinical efficacy or specific performance benchmarks.

Here's a breakdown of the requested information based on the provided text, with notes where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Compliance Standard)	Reported Device Performance (Compliance)
UL 60601-1: 2003 (Standards for Medical Equipment Part 1: General Requirements for Safety, 1st Edition)	In compliance
IEC 60601-1-2: 2001 (Medical Electrical Equipment Part 1 - 2: General requirements for Safety - Collateral Standard, Electromagnetic Compatibility --Requirements and Tests, 2nd Edition)	In compliance

Note: The document does not specify performance acceptance criteria related to clinical effectiveness (e.g., specific pain reduction percentages, range of motion improvements, or target success rates). The primary "performance" reported is compliance with safety and EMC standards and technical similarity to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size of Test Set: Not applicable. The submission is for a medical device seeking market clearance through substantial equivalence, not a clinical study with a test set of patient data for performance evaluation against ground truth. The "test set" here refers to the device itself being tested for compliance with technical standards.
Data Provenance: Not applicable for a clinical test set. The data provenance described is the device's technical specifications and comparisons to predicate devices for substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. This document does not describe a study where experts established ground truth for a clinical test set. The "ground truth" for this submission revolves around established safety and EMC standards, and the technical characteristics of predicate devices.
Qualifications of Experts: Not applicable for a clinical test set. The compliance with standards would be assessed by testing laboratories and regulatory bodies.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no mention of an adjudication process for a clinical test set in this 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. The document does not describe an MRMC comparative effectiveness study.
Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no MRMC study was conducted, and the device is a powered traction unit, not an AI-assisted diagnostic or interpretative system. The optional EMG biofeedback feature provides data for the clinician but isn't described as an AI-driven interpretive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? No. The device is a physical therapy traction unit, and its function involves direct human application and interaction (clinician administering treatment, patient interacting with the device). There is no "algorithm only" performance that would be evaluated in a standalone study without human involvement.

7. Type of Ground Truth Used

Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is established by:
- Regulatory Standards: Compliance with recognized safety and electromagnetic compatibility standards (UL 60601-1: 2003, IEC 60601-1-2: 2001).
- Predicate Device Characteristics: The technical specifications and indications for use of the listed predicate devices (e.g., Triton/Tru-Trac/TX Traction, Eskotek EST Trac 401 Traction, etc.) serve as the benchmark for demonstrating substantial equivalence. The argument for substantial equivalence is based on comparing the new device's features, intended use, and technological characteristics to those of legally marketed predicate devices.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven device that requires a training set of data for an algorithm. The device is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary

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Page 1 of 3

510(k) Summary - K053223	FEB 2 4 2006
SUBMITTER:	Chattanooga Group,A Division of Encore Medical, L.P.4717 Adams RoadHixson, TN 37343
CONTACT PERSON:	Michael TreasManager of Regulatory AffairsPhone: (423) 870-2281 ext. 7207Fax: (423) 870-7404
DATE PREPARED:	February 22, 2006
DEVICE TRADE NAME:	Triton/ Tru-Trac/ TX/ Triton DTS Traction
COMMON/ USUAL NAME:	Powered Traction Equipment
CLASSIFICATION	Class II (Product Code ITH)
PREDICATE DEVICES	K051938 - Triton/ Tru-Trac/ TX Traction,K844385 - Eskotek EST Trac 401 Traction,K992733 - Akron ATP9,K053503 - VAX-D Genesis System,K031862 - SpineRx-LDM,K001361 - Jilco,K030060 - SpineMed,K972487 - EMG Retrainer,K881416 - MyoTrac

DEVICE DESCRIPTION:

K053223 Summary Page 1 of 3

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K053223

Page 2 of 3

A comparison of device features demonstrate that the Triton/ Tru-Trac/ TX/ Triton DTS Traction device is substantially equivalent to the following devices:

Predicate device name and product code	510(k) number
Triton/ Tru-Trac/ TX TractionITH, Powered Traction Equipment	K051938
Eskotek EST Trac 401 Traction(a.k.a. Tru-Trac 401)ITH, Powered Traction Equipment	K844385
Akron ATP9Traction DeviceITH Powered Traction Equipment	K992733
VAX-D Genesis SystemTraction DeviceITH, Powered Traction Equipment	K053503
SpineRx-LDMTraction DeviceITH, Powered Traction Equipment	K031862
JilcoTraction DeviceITH, Powered Traction Equipment	K001361
SpineMedTraction DeviceITH, Powered Traction Equipment	K030060
EMG RetrainerHCC, Biofeedback	K972487
MyoTracHCC, Biofeedback	K881416

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K05322}

Page 3 of 3

Declarations of Conformity

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices is in compliance with the following FDA recognized Consensus Standards:

UL 60601-1: 2003, Standards for Medical Equipment Part 1: General Requirements for Safety, 1st Edition

IEC 60601-1-2: 2001, Medical Electrical Equipment Part 1 - 2: General requirements for Safety - Collateral Standard, Electromagnetic Compatibility --Requirements and Tests, 2nd Edition

Truthful and Accurate Statement

A statement attesting to the truthfulness and accuracy of the information contained in this submission is attached in Section 3.

Further Information

In the event that additional information is required, please contact:

Michael Treas Manager of Regulatory Affairs Chattanooga Group, A Division of Encore Medical, L.P. 4717 Adams Road Hixson, TN 37377 U.S.A. Telephone: (423) 870-2281 ext. 7207 Fax: (423) 870-7404 E-mail: Michael Treas(@ChattGroup.com

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a simplified or stylized version of the official HHS seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2006

Chattanooga Group c/o Mr. Michael Treas Manager of Regulatory Affairs 4717 Adams Road Hixson, Tennessee 37343

Re: K053223

Trade/Device Name: Triton/Tru-Trac/TX/Triton DTS Traction Regulation Number: 21 CFR 890.5900 Regulation Name: Powered traction equipment Regulatory Class: II Product Code: ITH Dated: February 7, 2006 Received: February 9, 2006

Dear Mr. Treas:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nare reveal 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 for ass based in 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 Errth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Treas

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA linding 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) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,
dell

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

Enclosure

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510(k) Number (if known): _ K 05 32 23 Device Name:

Indications for Use:

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles.

The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices with the optional EMG (a.k.a. sEMG) biofeedback feature may be used to relieve peripheral radiation/sciatica and nain associated with:

➤ Protruding discs	➤ Spinal root impingement
➤ Bulging discs	➤ Hypomobility
➤ Herniated discs	➤ Degenerative joint disease
➤ Degenerative disc disease	➤ Facet syndrome
➤ Posterior facet syndrome	➤ Compressions fractures
➤ Acute facet problems	➤ Joint pain
➤ Radicular pain	➤ Discogenic pain
➤ Prolapsed discs

EMG (a.k.a. sEMG)

Determination of the activation magnitude and timing of muscles for:

a) retraining of muscle activation

b) coordination of muscle activation
Determination of the force produced by muscle for control and maintenance of muscle contractions

and the comments of the comments of the comments of the comments of the comments of the comments of

Relaxation muscle training

Muscle re-education

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

---------------------------------------------------------e Evaluation (ODE) Concurrence of CDRH, Qff

Q.Y.M.D.L.

(Division of City Costs)

(Division Signe Off) Division of General, Restorative.

and Neurological Devices

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Regulation Number and Section

§ 890.5900 Power traction equipment.

(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).