The DRX9000 True Decompression System is designed to relieve pressure on structures that may be causing low back pain and sciatica. It relieves the pain associated with herniated discs, degenerative disc disease, posterior facet syndrome and radicular pain. Intervertebral disc decompression is achieved non-surgically through the application of logarithmic distraction tensions applied to the patient according to the Axiom protocol.

The DRX9000 True Non-Surgical Spinal Decompression System provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome and sciatica.

Device Description

The DRX9000 True Non-Surgical Spinal Decompression System provides accurately controlled tensions designed to relax and confuse paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. The user interface provided by the treatment computer constantly updates a servo-amplifier controlling a servo-motor to immediately and safely apply forces as determined by qualified healthcare personnel. Load-cell feedback is utilized to further verify and adjust tensile forces, allowing for variations in patient posture and outside forces such that continuous and smooth tension is experienced by the patient. The patient safety switch is held by the patient who at anytime and for any reason may quickly pause any tensile forces. This patient safety switch is monitored and executed by two redundant systems. Integral to effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, dedicated and matched servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), two segment (upper and lower) textile patient harness, patient safety switch, and free-floating lower body mattress. The free-floating lower body mattress allows the interdiscal segments of the lumbar spine to decompress at their own rate. As tension is cycled, the lower body can extend independent of the upper body which is held in place via an upper body textile patient harness. The treatment bed and textile harness allow the patient to relax completely and require no conscious exertion on the part of the patient. Total patient relaxation encourages paraspinal muscle relaxation from both a physical and psychological standpoint and is a key to spinal decompression.

AI/ML Overview

The provided document is a 510(k) summary for the DRX9000 True Non-Surgical Spinal Decompression System. It focuses on demonstrating substantial equivalence to predicate devices for market clearance, rather than presenting a detailed clinical study with acceptance criteria and device performance as typically seen for novel medical devices or AI-driven systems.

Therefore, much of the requested information cannot be found in this specific document because it describes a substantial equivalence submission, not a study designed to prove acceptance criteria for a novel device or AI.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or detailed device performance metrics (e.g., accuracy, sensitivity, specificity, or reduction in pain scores tied to a pre-defined threshold) in the format of a clinical study outcome. The submission focuses on the device's technological characteristics being "essentially the same" as predicate devices and its inherent safety due to a lack of reported injuries.

Acceptance Criteria	Reported Device Performance
Not specified in this 510(k) summary. This type of submission relies on substantial equivalence to predicate devices, not on meeting predefined performance criteria through a novel clinical study.	Not specified in this 510(k) summary in a quantitative, study-based manner. However, the document states: "Axiom Worldwide therapy has been in clinical use since 2002 and has been the subject of clinical studies examining its effectiveness." and "over the past twelve years, not a single claim of injury has been filed, which reflects the inherent safety of the device." This implies effectiveness and safety were observed in clinical use, but no specific performance metrics are provided here.

Acceptance Criteria

Reported Device Performance

Not specified in this 510(k) summary. This type of submission relies on substantial equivalence to predicate devices, not on meeting predefined performance criteria through a novel clinical study.

Not specified in this 510(k) summary in a quantitative, study-based manner. However, the document states: "Axiom Worldwide therapy has been in clinical use since 2002 and has been the subject of clinical studies examining its effectiveness." and "over the past twelve years, not a single claim of injury has been filed, which reflects the inherent safety of the device." This implies effectiveness and safety were observed in clinical use, but no specific performance metrics are provided here.

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

This document does not describe a new clinical "test set" in the context of validating performance against specific acceptance criteria. The information provided relates to general clinical use.

Sample Size for Test Set: Not applicable/Not specified.
Data Provenance: The document states "Axiom Worldwide therapy has been in clinical use since 2002." This suggests real-world clinical data, but specifics on country of origin, retrospective/prospective nature, or if it constitutes a formal "test set" are not provided.

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

Since a formal "test set" with ground truth establishment for a novel performance validation is not detailed, this information is not available.

Number of Experts: Not applicable/Not specified.
Qualifications of Experts: Not applicable/Not specified.

4. Adjudication Method for the Test Set

As no specific test set requiring adjudication is described, this information is not applicable.

Adjudication Method: Not applicable/Not specified.

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

This document does not mention any MRMC study. The device is a physical therapy device (non-surgical spinal decompression system), not an imaging or diagnostic aid where an MRMC study comparing human readers with and without AI assistance would be relevant.

MRMC Study: No.
Effect Size of Human Readers with AI vs. without AI: Not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This device is a physical therapy system requiring human operation and patient interaction. It is not an AI algorithm that would have a "standalone" performance.

Standalone Study: No.

7. Type of Ground Truth Used

The document speaks to the "effectiveness" of the therapy in general clinical use and "relief of pain and symptoms." If any "ground truth" were inferred, it would likely be patient-reported outcomes (e.g., pain reduction, functional improvement) or physician assessments of symptom relief. However, no specific methodology for establishing ground truth is described in this submission.

Type of Ground Truth: Not explicitly defined or used in a formal study context within this document. Effectiveness is mentioned in terms of "relief of pain and symptoms associated with herniated discs, bulging... degenerative disc disease, posterior facet syndrome and sciatica."

8. Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Any "training" would refer to the development and refinement of the mechanical system itself, not data-driven model training.

Sample Size for Training Set: Not applicable.

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

As there is no "training set" for an AI/ML algorithm, this question is not applicable.

How Ground Truth for Training Set Was Established: Not applicable.

Summary of what the document does provide:

Device Description: The DRX9000 is a non-surgical spinal decompression system.
Intended Use/Indications for Use: To relieve pressure on structures causing low back pain and sciatica, associated with herniated discs, degenerative disc disease, posterior facet syndrome, and radicular pain.
Predicate Devices: K022602 DRX3000 (Axiom Worldwide) and K053503 VAX-D Genesis System (VAX-D Medical Technologies).
Basis for Clearance: Substantial equivalence to predicate devices, based on similar technological characteristics and an assessment that modifications to the DRX3000 did not impact safety and effectiveness.
Safety Information: "over the past twelve years, not a single claim of injury has been filed."
Clinical Use Mention: "Axiom Worldwide therapy has been in clinical use since 2002 and has been the subject of clinical studies examining its effectiveness." (However, details of these studies are not provided in this 510(k) summary).

This 510(k) submission is a regulatory filing focused on establishing substantial equivalence for market clearance, not a detailed scientific publication of a clinical trial with performance metrics against predefined acceptance criteria for a novel device or AI.

Summary

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MAY 2 6 2006

SECTION VIII

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Sponsor Identification
  Axiom Worldwide, Inc. 9423 Corporate Lake Dr Tampa, FL 33634 Telephone: (813) 249-6444 Facsimile: (813) 249-6445

2. Sponsor Establishment Registration Number Establishment Registration Number: 3004378341 Owner / Operator Number: 9044586

1. Official Contact Person Jim Gibson
  Telephone: (813) 249-6444 Facsimile: (813) 249-6445

4. Device Information

DRX9000 True Non-Surgical Device Trade Name: Spinal Decompression System Common Name: Traction Equipment Classification Name: Power Traction Equipment Class and Reference Class II (21 CFR Section 890.5900) Product Code: 89 ITH Panel Code: 87 ORS

ડ. Predicate Devices

K022602 DRX3000 - Axiom Worldwide K053503 VAX-D Genesis System - VAX-D Medical Technologies

6. Device Description

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pause any tensile forces. This patient safety switch is monitored and executed by two redundant systems. Integral to effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, dedicated and matched servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), two segment (upper and lower) textile patient harness, patient safety switch, and free-floating lower body mattress. The free-floating lower body mattress allows the interdiscal segments of the lumbar spine to decompress at their own rate. As tension is cycled, the lower body can extend independent of the upper body which is held in place via an upper body textile patient harness. The treatment bed and textile harness allow the patient to relax completely and require no conscious exertion on the part of the patient. Total patient relaxation encourages paraspinal muscle relaxation from both a physical and psychological standpoint and is a key to spinal decompression.

7. Intended Use

8. Indications for Use

9. Technological Characteristics

The Axiom Worldwide DRX9000 True Non-Surgical Spinal Decompression System is essentially the same product as the predicate device (DRX3000). Axiom Worldwide has made some modifications to the appearance and components used in the Axiom Worldwide DRX3000 to provide more accurate application of tension. Each of these changes were evaluated by Axiom Worldwide and found not to impact the safety and effectiveness of this device.

10. Summary of Safety and Effectiveness

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effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, dedicated and matched servoamplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), two segment (upper and lower) textile patient harness, patient safety switch, and free-floating (apper and is mattress. An important safety feature is that patients hold a patient safety switch to allow at anytime the pausing of any tensile forces. Axiom Worldwide therapy has been in clinical use since 2002 and has been the subject of clinical studies examining its effectiveness. Axiom Worldwide maintains contact with the clinics administering the therapy, and over the past twelve years, not a while the othere 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 seal of the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

MAY 2 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Axiom Worldwide, Inc. % TÜV Rheinland of North America, Inc. Mr. Tamas Borsai Program Manager 12 Commerce Road Newtown, Connecticut 06470

Re: K060735

Trade/Device Name: DRX9000 True Non-Surgical Spinal Decompression System Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: Class II ** Product Code: ITH Dated: May 9, 2006 Received: May 11, 2006

Dear Mr. Borsai:

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. Tamas Borsai

Enclosure

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter natification. The FDA finding of substantial equivalence of your device to a legally promated 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 general 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,

$\mathcal{f}$

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

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Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Indications for Use

510(k) Number (if known): K060735

Device Name: DRX9000 True Non-Surgical Spinal Decompression System

INDICATIONS FOR USE

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

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

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

Hebert Lemon
(Division Sign-Off)

പ്പുള്ളും ല്‍ട്ടില്ലെങ്ങില്‍ Bestonation (ODE) Concul and Neurological Devices

510(k) Number K060735

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ళ

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).