Lo-Bak TRAX is intended for single person use by adults to provide portable, nonpowered traction force to the lumbar spine and to stretch and relax the para-spinal muscles and soft tissues.

Use of Lo-Bak TRAX is indicated for the following conditions: low back pain, degenerative disc disease, spinal degenerative joint disease, spinal stenosis, herniated disc, spinal curvature due to tight muscles, sciatica and muscle spasm.

Device Description

Lo-Bak TRAX is a non-powered, portable spinal traction device which is designed to simplify spinal traction of the lumbar spine and stretch the para-spinal soft tissues. It is light-weight (weighs less than 5 pounds) and compact, yet very strong and durable. Much like bicycle handlebars, there is a right and left handle. Correspondingly, there is a right and left thigh contact. The two thigh contacts are designed to align with the inguinal/thigh crease formed where the upper-most thigh attaches to the trunk when the hips are flexed 90 degrees. It has foam handle grips and ¼" SCE foam leg contact pads which both, provide comfort and function to prevent slippage while using the device. It is powder-coated with high gloss paint to make clean up easy with a warm, soapy cloth or disinfective wipe.

There are no moving parts and no assembly required. It is ready to use from the moment you take it out of the box.

This device is designed to traction the lumbar spine by utilizing the upper thighs as the contact point and the bilateral upper extremities as the traction force source. The device will accomplish this by having the user lie in a supine posture with the lower extremities flexed at both the hips and knees bilaterally with the heels positioned as close as comfortable to the corresponding buttock area. This posture flattens the lumbar lordosis, creating more of a straight line force vector which results in unweighting of the discs and facet joints while simultaneously relaxing the surrounding para-spinal musculature. This posture makes the spine more amenable to distraction with less force required than a device which attempts to traction the lumbar spine with the lumbar lordosis maintained.

AI/ML Overview

Here's a breakdown of the acceptance criteria and related study information for the Lo-Bak TRAX device, based on the provided 510(k) summary:

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study for novel performance metrics with specific acceptance criteria in the manner typical for AI/ML devices. Therefore, a direct table of "acceptance criteria and reported device performance" as might be found for quantitative diagnostic or prognostic devices is not explicitly stated. The acceptance criteria here are implicitly met if the device demonstrates comparable safety and effectiveness to the predicate.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Summary of Safety and Effectiveness Claim)
Safety: Device does not adversely affect user safety compared to the predicate device.	"Lo-Bak TRAX's new approach to lumbar spine traction does not adversely affect safety or effectiveness as compared to the predicate device." Key safety attributes cited: User-controlled force source with no reliance on mechanical involvement; biomechanical postural approach to maximize comfort while minimizing force; intermittent traction; one-piece design with no moving parts.
Effectiveness: Device maintains effectiveness for its intended use and indications compared to the predicate device.	"Lo-Bak TRAX's new approach to lumbar spine traction does not adversely affect safety or effectiveness as compared to the predicate device." The device is designed to "simplify spinal traction of the lumbar spine and stretch the para-spinal soft tissues." Effectiveness is tied to the ability to provide "significant traction to the lumbar spine area without the need for any cables, pulleys, restraints or weights," and "unweighting of the discs and facet joints while simultaneously relaxing the surrounding para-spinal musculature."
Indications for Use: Lo-Bak TRAX is suitable for the stated conditions (low back pain, degenerative disc disease, etc.).	The device is indicated for a range of conditions, similar to those that might benefit from the predicate device's function. The submission implicitly argues that the mechanism of action (traction, unweighting, muscle relaxation) is comparable and thus effective for these indications.
Technological Characteristics: Key differences from the predicate device do not raise new questions of safety or effectiveness.	The submission highlights differences (lightweight, portable, supine posture, user-generated intermittent traction, no moving parts, no assembly) and argues that these "do not adversely affect safety or effectiveness." These differences are presented as improvements or alternative approaches that maintain the core functionality without introducing new risks.

Study Information Details

The provided document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not describe a formal clinical study with a test set, ground truth establishment, or sample sizes in the manner typically associated with AI/ML device performance evaluation. Instead, the "proof" is through comparison of technological characteristics and intended use with a legally marketed predicate.

Therefore, many of the requested details are not applicable (N/A) in the context of this 510(k) submission.

Sample size used for the test set and the data provenance:
- N/A: The submission does not describe a formal test set for evaluating specific performance metrics. Substantial equivalence is argued based on the design, intended use, and comparison to the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: No ground truth establishment study involving experts is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: No adjudication method is described as there is no specific test set requiring ground truth establishment through expert consensus.
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:
- N/A: This device is a physical, non-powered orthopedic traction apparatus, not an AI/ML diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A: This is a physical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- N/A: The safety and effectiveness argument relies on the well-understood principles of spinal traction and comparison to a predicate, not on a new ground truth established through a study.
The sample size for the training set:
- N/A: The device is not an AI/ML product that requires a training set.
How the ground truth for the training set was established:
- N/A: Not applicable, as there is no training set for this type of device.

In summary, this 510(k) document demonstrates substantial equivalence by comparing the Lo-Bak TRAX to a predicate device (Teeter Hang Up's Inversion Table) based on:

Similarities in intended use and fundamental mechanism of action (spinal traction, unweighting discs/facets, relaxing muscles).
Differences in physical attributes and method of force generation that are argued not to raise new questions of safety or effectiveness.
The argument that the device's design (user-controlled, intermittent traction, specific posture) maintains effectiveness while potentially enhancing safety and ease of use.

Summary

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K1.10858

510(k) Summary

AUG - 2 2011

Owners Name: Roland F. Berthiaume, DC Address: 585 Cooley Street Springfield, MA. 01128 Phone: 413-783-3800 Fax: 413-783-7170 E-mail: DrBerthiaume@aol.com

Contact Person: Same Date Prepared: 3/17/2011

Device Name: Lo-Bak TRAX Classification Name: Non-powered Orthopedic Traction Apparatus and Accessories (CFR) 888.5850, Type 1 device, Product Code: HST

Legally Marketed Predicate: Teeter Hang Up's Inversion Table. Model # EP550

Device Description: Lo-Bak TRAX is a non-powered, portable spinal traction device which is designed to simplify spinal traction of the lumbar spine and stretch the para-spinal soft tissues. It is light-weight (weighs less than 5 pounds) and compact, yet very strong and durable. Much like bicycle handlebars, there is a right and left handle. Correspondingly, there is a right and left thigh contact. The two thigh contacts are designed to align with the inguinal/thigh crease formed where the upper-most thigh attaches to the trunk when the hips are flexed 90 degrees. It has foam handle grips and ¼" SCE foam leg contact pads which both, provide comfort and function to prevent slippage while using the device. It is powder-coated with high gloss paint to make clean up easy with a warm, soapy cloth or disinfective wipe.

There are no moving parts and no assembly required. It is ready to use from the moment you take it out of the box.

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510(k) Summary, cont.

Once the thigh contact is made, the user pushes the handles towards the feet utilizing the upper extremities/body as the traction force source. This device and posture provides significant traction to the lumbar spine area without the need for any cables, pulleys, restraints or weights.

Because the device is user-controlled, the force utilized is totally under the control of the user. The hold time for the force is between 20-30 seconds at a time, and the protocol calls for 4-6 repetitions with a 90-120 second rest time in between repetitions for a total treatment time of between 10-15 minutes. This is an intermittent form of traction. The user will feel when too much force is being applied and is ultimately the best judge of how much force they can tolerate on a specific day. The user is in total control at all times of the amount of force applied and even, the direction of the force. The direction can be varied by the user to affect not only different levels of the spine, but from right to left as well, simply based upon where the thigh contacts are placed and how much force is applied to either handle. The energy supplied is all based upon the user's own upper body strength.

Indications for Use:

Lo-Bak TRAX is intended for single person use by adults to provide portable, non-powered traction force to the lumbar spine and to stretch and relax the para-spinal muscles and soft tissues.

Technological Characteristics Similarities vs. Differences:

Lo-Bak TRAX and Predicate Device Similarities:

. Both are Non-powered, Non-invasive Orthopedic Traction Devices.
. Both target the spine with their treatment.
Both cause unweighting of the intervertebral discs and facet joints due to distraction . and positioning.
. Both stretch and relax the muscles and soft tissues surrounding the spine.
. Both naturally target low back pain and its associated disability without the need for complimentary modalities.
. Both are user controlled.
. Both are designed for home use by adults, without the need for supervision.

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Device & Predicate Device(s):	K110858Lo-Bak TRAX	Teeter Hang UpsInversion TableModel 550(Exempt)From website
Physical Attributes & Indicators:
Basic Materials	Powder-coated metaltubing, foam handgrips and pads,stainless steel thighcontacts	Powder coatedmetal tubing, rubbercoated hand grips,sling surface ofunknown material
	23" x 9" x 4"	48" x 27" x 61"
Measurements and Weight	3.5lb's	68lb's
Treatment Position	Supine, with hipsflexed approx 80 deg.and feet resting flat	Supine with anklessecured - variabledegree of inversion.Legs extended.
Method of Generating Traction Force	Pressure exerted byuser's upperextremities pushing onhandle bars, withbilateral upper thighsas contact points	Gravity assisted byvariable degrees ofinversion (up to fullinversion)
Amount of Traction Force Supplied	Variable - based onforce exerted by user	Variable - based ondegree of inversion -body weight +gravity assist
Force Gauge	No	No
Assembly Required by User	No	Yes

Lo-Bak TRAX and Predicate Device Differences:

Lo-Bak TRAX is designed to be lightweight and portable.

Lo-Bak TRAX is designed to utilize a supine lying posture for comfort, effectiveness and safety.

Lo-Bak TRAX is designed to utilize user generated and controlled intermittent type traction.

Lo-Bak TRAX is designed with no moving parts or assembly required and is ready to use from the moment it is taken out of the box.

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Summary of safety and effectiveness:

Lo-Bak TRAX was designed to address the need for a portable, simple to use, safer way of tractioning the lumbar spine while maintaining the effectiveness of such a device. Lo-Bak TRAX's new approach to lumbar spine traction does not adversely affect safety or effectiveness as compared to the predicate device.

The important attributes contributing to the safety and effectiveness of Lo-Bak TRAX include: the user controlled force source with no reliance on mechanical involvement to initiate, the new biomechanical postural approach designed to maximize comfort while minimizing the force necessary to achieve unweighting of the discs and facet joints while simultaneously stretching and relaxing the para-spinal soft tissues, the intermittent form of traction, and it's one piece design with no moving parts.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Berthiaume Chiropractic % Roland F. Berthiaume, DC 585 Cooley Street Springfield. Massachusetts 01128

Re: K110858

AUG - 2 2011

Trade/Device Name: Lo-Bak TRAX Regulation Number: 21 CFR 888.5850 Regulation Name: Nonpowered orthopedic traction apparatus and accessories Regulatory Class: Class I Product Code: HST Dated: July 25, 2011 Received: July 28, 2011

Dear Dr. Berthiaume:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2- Roland F. Berthiaume, DC

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark A. Milliken

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

Enclosure

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Indications for Use

510(k) Number: K110858

Device Name: Lo-Bak TRAX

Indications for Use:

Lo-Bak TRAX is intended for single person use by adults to provide portable, nonpowered traction force to the lumbar spine and to stretch and relax the para-spinal muscles and soft tissues.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign Division of Surgical, Orthopedic, and Restorative Devices

IND-1

510(k) Number K110858

Regulation Number and Section

§ 888.5850 Nonpowered orthopedic traction apparatus and accessories.

(a)
Identification. A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.