The VAX-D Genesis G2 Dynamic Logarithmic Spinal Decompression System is designed to relieve pressure on structures that may be causing low back pain, sciatica and neck pain. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radio. This is achieved non-surgically through the application of logarithmic distraction tensions applied to the patient according to the VAX-D protocol.

This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with spinal pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the spine that generate localized pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs as well as those with acute facet problems and sciatica.

Device Description

The VAX-D Genesis G2 is designed to apply distraction tensions to the patient's lumbar and cervical spine in order to non-surgically decompress the spine and intervertebral disc. Disc decompression is defined as unloading due to distraction and positioning. For lumbar treatment the patient is fitted with pelvic harness and lies on the table; the upper body is positioned on the stationary partion of the table and is restrained by the patient holding on to adjustable handgrips, or by the vise of possive shoulder restraint. The table is a split table design, whereby distraction tensions are applied to the patient through a harness attached to a tensionometer and by the separation of the movable part of the movable The tensionometer can be programmed to move synchronously in a horizontal rand vertical plane in order to apply tension in a logarithmic time/force progression that is designed to follow the curvature of the spine.

The system is designed to apply tensions to the spine in a smooth logarithmic time/force curve that allows trunk and paraspinal muscles to relax. The system provides automated or variable e ined distraction-relaxation cycles. For safety the patient holds on to handgrips which can be released at any time to end the session and restore full relaxation. The patient may choose to use a passive shoulder restraint that utilizes a patient 'quick release' buckle, or they may use the handheld patient safety witch to stop the treatment. For cervical treatment the tensionometer applies tension to the cervical spine through a cervical harness. Distraction tensions and rates are continuously monitored and measured hy the tensionometer, and the output is monitored by a computer system which continuously processes the data and adjusts the tension to produce a patented 'logarithmic' curve. The chart recording produced is a permanent record of the treatment parameters which becomes part of the patient's chart.

AI/ML Overview

The provided text is a 510(k) summary for the VAX-D Genesis G2 device. It describes the device, its intended use, indications for use, and technological characteristics, and references predicate devices. However, this document is a premarket notification for a medical device and does not contain a study that proves the device meets acceptance criteria in the way you've outlined for performance studies (e.g., specific metrics like sensitivity, specificity, or reader improvement).

Instead, the document asserts the safety and effectiveness of the VAX-D Genesis G2 by demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" in this context are not quantitative performance metrics from a controlled study, but rather the FDA's regulatory requirements for substantial equivalence, which primarily relate to intended use, technological characteristics, and safety and effectiveness.

Here's a breakdown of why I cannot fill out your requested table and information, followed by what the document does provide:

Why the requested information cannot be provided from this document:

No acceptance criteria table or reported device performance metrics: The document does not define specific, quantifiable acceptance criteria (e.g., minimum sensitivity, AUC, or reader improvement percentages) for the device's clinical performance. It also does not report specific performance outcomes from a study against such criteria.
No sample size for test set, data provenance, ground truth experts, or adjudication method: These details are characteristic of clinical studies, particularly performance studies for diagnostic or AI-powered devices. This document is a regulatory submission focused on equivalence, not a detailed clinical trial report.
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document doesn't describe any study comparing human readers with and without AI assistance. The device itself is a spinal decompression system, not a diagnostic imaging AI.
No standalone algorithm performance study: The VAX-D Genesis G2 is a physical medical device (a spinal decompression system), not a software algorithm, so a "standalone" algorithm performance study is not applicable.
No type of ground truth, training set sample size, or training set ground truth establishment: These are concepts related to the development and validation of machine learning or AI models. This device is a physical therapeutic device.

What the document does provide regarding "acceptance" and "proof":

The "proof" in this 510(k) submission is the demonstration of substantial equivalence to predicate devices. The FDA's "acceptance" is represented by their letter stating that the device is substantially equivalent and thus can be marketed.

1. Acceptance Criteria (implicit for 510(k) Substantial Equivalence):

The implicit "acceptance criteria" for a 510(k) clearance are that the new device shares the same intended use and/or indications for use as a legally marketed predicate device, and it is as safe and effective as the predicate device(s). If there are technological differences, they must not raise different questions of safety and effectiveness, or if they do, adequate scientific evidence must demonstrate that the device is as safe and effective as the predicate.

Acceptance Criterion	Reported Device Performance (as per 510(k) argument)
Intended Use	To relieve pressure on structures that may be causing low back pain, sciatica and neck pain, through non-surgical distraction tensions. (Same as predicate)
Indications for Use	Management of pain and disability for patients suffering with spinal pain, including herniated discs, degenerative disc disease, posterior facet syndrome, and sciatica. (Same as predicate)
Technological Characteristics	Incorporates principles and working characteristics of predicate devices (VAX-D Genesis System K053503, VAX-D Therapeutic Table K951622, 3D Activetrac K001712, Henley Tru-Trac 401 K844385). Modifications (control arm, more accurate tension application, patient data storage) were evaluated and found not to impact safety and effectiveness.
Safety	Patients can immediately release tensions; "not a single MDR report of injury has been filed" over fourteen years for VAX-D therapy in clinical use, reflecting inherent safety. (Based on predicate/therapy history)
Effectiveness	Operating principles allow accurately controlled distraction tensions to decompress discs, which is the mechanism of action for efficacy. (Based on predicate/therapy principles)

2. Study that proves the device meets acceptance criteria:

The document leverages the history and established safety/effectiveness of the predicate devices and the VAX-D therapy concept itself. It doesn't present a novel, prospective clinical study designed to meet specific quantitative performance endpoints for the G2 model.

Sample size used for the test set and the data provenance: Not applicable in the context of a de novo performance study for the G2. However, the document states: "VAX-D therapy has been in clinical use since 1989 and has been the subject of multiple clinical studies examining its effectiveness and mechanisms of action." It also notes that "VAX-D Medical Technologies maintains contact with the clinics administering the therapy, and over the past fourteen years, not a single MDR report of injury has been filed..." This refers to a broad history of clinical use and post-market surveillance rather than a specific test set for the G2.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: No.
Standalone algorithm performance study: No, as it's a physical device.
Type of ground truth used: For the claim of safety and effectiveness, the "ground truth" relies on the established body of evidence and clinical history of the predicate devices and the general VAX-D therapy principles, including the absence of reported adverse events (MDRs).
Sample size for the training set: Not applicable (not an AI/ML device).
How the ground truth for the training set was established: Not applicable.

In summary, the VAX-D Genesis G2 obtained FDA clearance through the 510(k) pathway by demonstrating substantial equivalence to existing predicate devices. The "proof" of meeting acceptance criteria is rooted in the known characteristics, intended use, safety record, and effectiveness of these established devices and the VAX-D therapy approach, rather than a new, detailed clinical performance study for the G2 model itself.

Summary

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VAXED GENESIS G2 510(k)

SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR IDENTIFICATION 1.

VAX-D MEDICAL TECHNOLOGIES LLC. 310 Mears Blvd Oldsmar, FL 34677

0CT 5 * 2007

K671347

Telephone: (813) 343-5000 Facsimile: (813) 343-5005

2. SPONSOR ESTABLISHMENT REGISTRATION NUMBER(s): 1058809 Owner ID No. 9031244

1. OFFICIAL CONTACT PERSON Dr. Lawrence A. Dyer Telephone:
  (813) 343-5000 Facsimile: (813) 343-5005
DATE OF PREPARATION OF SUMMARY: April 30, 2007 4.

5. DEVICE INFORMATION

DEVICE PROPRIETORY NAME: VAX-D Genesis G2 - Dynamic A. Logarithmic Spinal Decompression System

B. CLASS AND REFERENCE: Class II (21CFR Section 890.5900)
C. PRODUCT CODE: 89 ITH
D PANEL CODE: 87OR

6.	PREDICATE DEVICE(s):	VAX-D Genesis System	K053503
		VAX-D Therapeutic Table	K951622
		3D Activetrac	K001712
		Henley Tru-Trac 401	K844385

DEVICE DESCRIPTION .

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apply tension in a logarithmic time/force progression that is designed to follow the curvature of the spine.

8. INTENDED USE

9. INDICATIONS FOR USE

This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with spinal pain. It has been found to provide relief in a variety of sonditions involving anatomical dysfunctions of the spine that generate localized pain as well as veninheral radiation, including patients with protruding or herniated intervertebral disco as well as those with acute facet problems and sciatica.

10. TECHNOLOGICAL CHARACTERISTICS

The VAX-D Genesis G2 incorporates the various principles and working characteristics of the predicate devices, VAX-D Genesis System K053503, the VAX-D Therapeutic Table K951622, the aD Activetrac K001712 and the Henley Tru-Trac 401 K844385. VAX-D Medical Technologies has made some modifications to the appearance and components used in the VAX-D Genesis System which provides for a control arm instead of a control console; to provide for more accurate application of tension, and to provide for the storage of patient data. Each of these changes was evaluated by VA-D Medical Technologies and found not to impact the safety and effectiveness of this device. The Tru-Trac 401 has been in use for more than ten years for traction of the cervical spine and we have no evidence of an MDR report being filed by the manufacturer.

SUMMARY OF SAFETY AND EFFECTIVENESS 11.

The operating principles of the VAX-D Genesis G2 permit the application of accurately controlled distraction tensions to the lumbar and cervical spine in order to decompress the intervetebral

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discs and spinal structures. Disc decompression is defined as unloading due to distraction and The important basic parameters contributing to the safety and effectiveness of the device positioning. include the smooth and gentle logarithmically applied distraction tensions, the smooth logarithmic release rate of tensions and relaxation cycles, the cyclic periodicity, the upper limits on distraction tensions, and in addition, the positioning of the patient and the means of fixing the upper body. The important safety factors are that patients can immediately release all tensions by simply releasing the handgrips, by using the quick release buckle on the passive shoulder restraint or through the patient handheld safety switch.

VAX-D therapy has been in clinical use since 1989 and has been the subject of multiple clinical studies examining its effectiveness and mechanisms of action. VAX-D therapy Medical Technologies maintains contact with the clinics administering the therapy, and over the past fourteen years, not a single MDR report of injury has been filed, which reflects the inherent safety of the device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vax-D Medical Technologies USA % Regulatory Technology Services Mr. Mark Job 1394 25th Street Buffalo, MN 55313

OCT 5 2007

Re: K071347

Trade/Device Name: VAX-D Genesis G2-Dynamic Logarithmic Spinal Decompression System Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: September 19, 2007 Received: September 21, 2007

Dear Mr. Job:

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.

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Page 2 - Mr. Mark Job

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Yorbay Bneems

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

Enclosure

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Indications for Use

510(k) Number : ______________________________________________________________________________________________________________________________________________________________

Device Name: VAX-D Genesis G2

Indications for Use:

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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

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

Copeur ance of CDRH, Office of Device Evaluation (ODE)

Barbara Bucklin
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K071344/52

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).