The Model D -- Disc Force provides a program of traction type treatments for relief from pain for patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the Model D - Disc Force and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of inter-vertebral discs, that is, unloading due to distraction and positioning.

Device Description

The main parts of the Model D are as follow:

The bed is a stand on / stand off type of bed that can be tilted to allow the fully clothed patient to step onto a footrest while in the vertical position and then be slowly lowered to the horizontal treatment position using a remote control hand held by the practitioner.
The bed is split into two cushions which slide on low friction runners only in the horizontal plane and which can be locked independently.
Distraction tensions are applied to the patient via a pelvic harness while the upper torso is anchored to the locked cephalic cushion via a chest harness. The lower cushion, on which the lower torso of the patient rests, is unlocked and able to slide freely, thus negating any frictional movement between the patient and the bed cushions during the application of distraction forces and ensuring the efficiency of the application of the prescribed force.
The distraction unit is mounted to a vertical movable platform incorporated into a support tower at the foot end of the bed. This enables the distraction tensions to be applied at differing angles (ranging from 0 to 27 degrees) to the patient.
The distraction unit is programmable and controlled from a control panel fitted into the tower to provide static or intermittent distraction.
The minimum and maximum distraction settings are 0 200 pounds.
Treatment parameters, such as time and tension, are continuously monitored and displayed by the control panel during set up and during treatment.
At the conclusion of the duration of the treatment session, the tension always returns to zero.
A flat panel monitor, which is incorporated in a separate section of the control tower, with headphones provides comfort and relaxation to the patient and / or educational opportunities.
The system incorporates a Patient Interrupt Switch; an Emergency Interrupt Switch; and a Power Switch, which, when selected independently, in tandem, or in unison, results in the immediate release of all tension.
The Model D will not operate if the Patient Switch is not working properly or has not been tested prior to the commencement of each treatment session.
If the Patient Interrupt Switch, or the Emergency Interrupt Switch is activated during a session, or power is interrupted, all treatment parameters must be manually re-entered before the treatment session will restart.

AI/ML Overview

The provided text is a 510(k) notification submission for the Chirotronics Model D, a powered traction equipment device. The document details the device description, intended use, technological characteristics, and a summary of safety and effectiveness.

However, the submission does not include any acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety features.

Therefore, most of the requested information cannot be extracted from this document, as a formal study with acceptance criteria, ground truth, and statistical analysis is not present. The device relies on "Summary of Safety and Effectiveness" based on its design characteristics and comparison to predicate devices, rather than a quantifiable performance study.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and reported device performance:

Cannot be provided. The document does not define specific acceptance criteria or report quantifiable performance metrics from a study against such criteria. The safety and effectiveness summary lists design features and operational safeguards, but not performance outcomes in patients against predefined targets.

2. Sample size used for the test set and data provenance:

Cannot be provided. There is no mention of a test set, study population, or data origin for evaluating the device's performance.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Cannot be provided. No ground truth establishment is described, as no performance study is detailed.

4. Adjudication method for the test set:

Cannot be provided. No test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Cannot be provided. This device is a physical therapy traction device, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related metrics are not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Cannot be provided. This is not an algorithmic device in the sense of a diagnostic or analytical algorithm; it's a therapeutic physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Cannot be provided. No ground truth is described because no performance study is detailed. The submission focuses on device design and safety features.

8. The sample size for the training set:

Cannot be provided. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Cannot be provided. Not applicable due to the nature of the device.

What the document does communicate regarding safety and effectiveness:

The document outlines safety and effectiveness characteristics based on the device's design and operational principles. These act as inherent "performance" features rather than measured outcomes from a clinical study:

Characteristic Category	Feature/Performance Description
Safety - Electrical	The bed actuator activation is via a 24-volt electric circuit. The control unit of the distraction unit, including the Patient Emergency Switch's power supply, is a maximum of 24 volts.
Safety - Patient Handling	The patient steps onto the bed while it is in the vertical position and is then reclined into the treatment position under the supervision of the attendant, not requiring climbing. Adjustable handgrips are fitted for patient support during reclining.
Safety - Interruptions	Patient Interrupt Switch, Emergency Interrupt Switch, and Power Switch immediately release all tension when activated independently, in tandem, or in unison. The Model D will not operate if the Patient Switch is not working properly or has not been tested. If a session is interrupted (by patient, attendant, or power loss), all tensions instantaneously release, and treatment parameters must be manually re-entered to restart. An audible warning signal sounds when the unit is turned on, when treatment is complete, and when the Patient Interrupt Switch is tested or activated.
Safety - Control Mechanisms	All treatment parameters must be physically inputted each session. The system defaults to a maximum tension of 200 pounds (lumbar) and 30 pounds (cervical) if inadvertently higher amounts are entered. A warning box must be responded to if a tension amount greater than one-half of the patient's body weight is entered.
Functional/Effectiveness	Provides static, intermittent, and cycling distraction forces. Distraction tensions can be applied at differing angles (0 to 27 degrees). Minimum and maximum distraction settings are 0-200 pounds. Treatment parameter (time and tension) are continuously monitored and displayed. At the conclusion of a session, tension always returns to zero. Limited vertical movement of the traction head. Permanent visible means of indication of the angle of distraction pull.

Study Proving Acceptance Criteria:

Based on the provided document, no specific study proving quantitative acceptance criteria was performed or detailed. The submission relies on a "Summary of Safety and Effectiveness" which asserts that the device has been designed to be safe and effective based on its technological characteristics, operational safeguards, and substantial equivalence to legally marketed predicate devices that have "been successfully manufactured and marketed... with no evidence of MDR events."

The FDA's response (K073132) confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. This determination of substantial equivalence is based on the information provided about its design, intended use, and technological characteristics, rather than a formal clinical study with predefined acceptance criteria and performance outcomes.

Summary

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Chirotronics Model D - 510(k) Notification Submission 20 September 2007

K073/32

510(k) Summary of Safety and Effectiveness

Device Description

Device Trade Name:

Common Name: Classification Name: Class: Reference: Product Code: Panel Code:

Model D Disc Force Traction Equipment Powered Traction Equipment Class II 21 CFR 890.5900 ITH 890 - Physical Medicine

APR - 3 2008

Predicate Devices:

K981822 - DRS K023160 - DRX500 K060735 - DRY9000

Intended Use:

The Model D provides a program of treatments for the relief from pain for those patients suffering from low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the Model D and is designed to provide static, intermittent, and cycling distraction forces to relieve pressure on structures that may be causing low back and neck pain. It achieves this through decompression of intervertebral discs - unloading due to distraction and positioning. Conditions which may be treated by this methodology include back and neck pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica.

Technological Characteristics:

The Model D incorporates various principles and working characteristics of the predicate devices. The incorporation of a traction device with a flat surface type powered bed remains the same, and the new overall appearance of the apparatus has not impacted on or changed the safety and effectiveness of the device.

Device Description:

The main parts of the Model D are as follow:

The bed is a stand on / stand off type of bed that can be tilted to allow the fully し. clothed patient to step onto a footrest while in the vertical position and then be slowly lowered to the horizontal treatment position using a remote control hand held by the practitioner.
The bed is split into two cushions which slide on low friction runners only in the 2. horizontal plane and which can be locked independently.

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Chirotronics Model D - 510(k) Notification Submission

Distraction tensions are applied to the patient via a pelvic harness while the upper 3. torso is anchored to the locked cephalic cushion via a chest harness. The lower cushion, on which the lower torso of the patient rests, is unlocked and able to slide freely, thus negating any frictional movement between the patient and the bed cushions during the application of distraction forces and ensuring the efficiency of the application of the prescribed force.
The distraction unit is mounted to a vertical movable platform incorporated into a 4. support tower at the foot end of the bed. This enables the distraction tensions to be applied at differing angles (ranging from 0 to 27 degrees) to the patient.
The distraction unit is programmable and controlled from a control panel fitted న్. into the tower to provide static or intermittent distraction.
The minimum and maximum distraction settings are 0 200 pounds. 6.
Treatment parameters, such as time and tension, are continuously monitored and 7. displayed by the control panel during set up and during treatment.
At the conclusion of the duration of the treatment session, the tension always 8. returns to zero.
A flat panel monitor, which is incorporated in a separate section of the control 9. tower, with headphones provides comfort and relaxation to the patient and / or educational opportunities.
The system incorporates a Patient Interrupt Switch; an Emergency Interrupt 10. Switch; and a Power Switch, which, when selected independently, in tandem, or in unison, results in the immediate release of all tension.
The Model D will not operate if the Patient Switch is not working properly or has 11. not been tested prior to the commencement of each treatment session.
If the Patient Interrupt Switch, or the Emergency Interrupt Switch is activated 12. during a session, or power is interrupted, all treatment parameters must be manually re-entered before the treatment session will restart.

Summary of Safety and Effectiveness:

The Model D has been designed to be safe and effective. The primary characteristics for safety and effectiveness include:

The bed actuator activation is via a 24-volt electric circuit. 1.
The control unit of the distraction unit, including the Patient Emergency Switch's 2. power supply is a maximum of 24 volts.
The patient steps onto the bed while it is in the vertical position and is then 3. reclined into the treatment position under the supervision of the attendant, and does not have to climb onto the treatment bed.
Adjustable handgrips are fitted for patient support during the reclining of the bed. 4.
There is an audible warning signal when the unit is first turned on, when the 5. treatment session is complete, when the Patient Interrupt Switch is tested or activated during a treatment session.

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Chirotronics Model D - 510(k) Notification Submission

Anytime a session is interrupted, whether as a result of patient input via the 6. Patient Interrupt Switch; attendant input via the Stop Session switch, or Power Switch; or power interruption, there is an instantaneous release of all tensions. In any of these instances, the treatment program has to be manually reentered into the control panel before treatment can re-commence.
All treatment parameters must be physically inputted each time a session occurs. 7.
There is limited vertical movement of the traction head. 8.
There is a permanent visible means of indication of the angle of distraction pull. 9.
The system defaults to a maximum tension of 200 pounds for lumbar session and 10. 30 pounds for a cervical session if an amount greater than these are inadvertently entered by the physician.
If a tension amount greater than one-half of the patient's body weight is entered, a 11. warning box must be responded to before the session can start.

Similar types of devices have been successfully manufactured and marketed in this country for over ten years with no evidence of MDR events.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

North American Medical Corp (NAM) % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, MN 55313

APR - 3 2008

Re: K073132

Trade/Device Name: Model D Disc Force Regulation Number: 21 CFR 890.5900 Regulation Names: Power traction equipment Regulatory Class: II Product Code: ITH Dated: March 18, 2008 Received: March 19, 2008

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becternined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the chorosure) to regars the Medical Device Amendments, or to commence provision of May 20, 1976, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that to not require approvine the general controls provisions of the Act. The You may, mercerore, market the act include requirements for annual registration, listing of general controls provisions of the 110 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 If your device is classified (500 abor of als. Existing major regulations affecting your device can may be subject to such additional controller and the games 800 to 898. In addition, FDA may oc found in the Oods of Peaching your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hiat I Dri 3 issualled of a backed complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must or any Fecelal statutes and regulations animals. 8 - 3 - 5 - 5 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 comply with an the Act 3 requirements, netwarts, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson 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 (if known): not known

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

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)

Concurrent of CDRH, Office of Device Evaluation (ODE)

Neithre 22. Gicmkn

Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number_KO73132

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).