The DRS System provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRS System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

Device Description

The DRS System™ is designed to apply distraction forces to a patient's lumbar spine. The key elements are as follows:

The bed is a stand on/stand off tilt type bed that allows the fully clothed patient to stand on the bed in the vertical position. The bed and patient can then be slowly lowered to the horizontal treatment position using a remote controller hand held by the practitioner.
Once in the horizontal position the bed can be raised or lowered to the practitioner's preferred treatment height via the same hand held remote controller.
The bed is split into two cushions, each slideable in the horizontal plane only on low friction runners and each being able to be locked independently.
Distraction tensions are applied to the patient via a pelvic harness while the upper body of the patient is anchored to the locked upper (cephalic) cushion via a chest harness and adjustable underarm supports. The lower cushion, which is unlocked and on which the patient's lower trunk is rested, is able to slide easily thus reducing almost completely any frictional movement between patient and bed cushion when distraction tensions are applied, this concentrates virtually all the forces to the affected part of the lumbar spine.
The distraction unit (Vertrac) is mounted to a vertical movable platform incorporated into a support tower (Omni Tower) at the foot end of the bed. This enables the distraction tensions to be applied at differing angles to the patient (between 0 and 30 degrees).
The "Vertrac" unit is programmed and control panel fitted into the "Omni Tower" to give static or intermittent distraction.
The minimum and maximum distraction settings are 0-200 lbs.
Treatment parameters i.e. tensions and time are continuously monitored and shown by LCD readout at the time of treatment set up and during treatment.
At the conclusion of treatment time, tension always returns to zero.
A cassette player, which is incorporated in a separate section of the control panel, and wireless headphones together with an overhead fluorescent "black light" provide comfort and relaxation to the patient.
There is instantaneous release of all tensions if the patient pushes the button on the hand held Patient Safety Switch, or the Stop Button on the control panel has been pushed by the practitioner.
The DRS System™ will not operate if the Patient Safety Switch is not working properly or has not been tested prior to each treatment.
The treatment cannot be restarted when a patient activates the Patient Safety Switch or the Stop Button has been pushed during treatment unless all treatment parameters are manually re-entered into the controller.

AI/ML Overview

The provided text describes a medical device, the DRS System™, which is intended to apply distraction forces to a patient's lumbar spine to relieve low back pain. However, it does not include acceptance criteria for the device's performance, nor does it detail a study that proves the device meets specific performance criteria in the way typically expected for a modern medical device submission (e.g., sensitivity, specificity, accuracy metrics).

Instead, the document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to predicate devices, rather than proving efficacy through clinical performance metrics against predefined acceptance criteria. This type of submission relies heavily on similarities in intended use, technological characteristics, and safety profiles to already legally marketed devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text because such information is not present. The document refers to "clinical trials carried out by VAX-D" (the predicate device) and "extracts from study papers carried out using The DRS System" to endorse the principle of decompression. However, it does not provide details of these studies in terms of methodology, sample size, ground truth, or outcome metrics with respect to specific acceptance criteria for the DRS System™ itself.

Here's an analysis of what can be extracted or inferred from the provided text, while acknowledging the severe limitations in fulfilling the request for detailed acceptance criteria and a study demonstrating their achievement:

Summary of Information from the Provided Text

The document is a 510(k) Summary of Safety and Effectiveness for the DRS System™ (K981822). This type of submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove standalone clinical efficacy against specific performance targets.

Table of Acceptance Criteria and Reported Device Performance:
- Not found in the document. The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or a measure of pain reduction against a predefined threshold). Therefore, no "reported device performance" against such criteria is provided.
Sample size used for the test set and the data provenance:
- Not found in the document. The document mentions "clinical trials carried out by VAX-D" (a predicate device) and "extracts from study papers carried out using The DRS System," but it does not provide details on the sample size or provenance (country of origin, retrospective/prospective) for any specific test set used in a performance study for the DRS System™.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not found in the document. Ground truth establishment methods, number of experts, and their qualifications are not detailed for any studies mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not found in the document. No information on adjudication methods for any test data is provided.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The DRS System™ is a mechanical traction device, not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As the DRS System™ is a mechanical device, the concept of a "standalone algorithm only" performance study does not apply. The device's operation is mechanical and controlled by practitioners.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred (Outcomes Data for Pain Relief): The "Intended Use" states the device "provides a program of treatments for relief from pain for those patients suffering with low back pain." The "clinical trials" and "study papers" are mentioned in the context of endorsing the "principle of decompression" and further confirming the same. This strongly suggests that outcomes data related to pain relief would be the relevant "ground truth" for efficacy, but the details of how this was measured or established in the mentioned studies are absent. The cited papers are:
  - Shealy, C. Norman, and Borgmeyer, Vera (1997) Decompression, Reduction, and Stabilization of the Lumbar Spine: A Cost Effective Treatment for Lumbosacral Pain. American Journal of Pain Management, Vol. 7, p. 63-65.
  - Shealy, C. Norman, and LeRoy, Pierre L. (1998) New Concepts in Back Pain Management: Decompression, Reduction, and Stabilization. St. Lucie Press, Boca Raton, FL. Chapter 20, p. 239-257.
    These are publications that presumably contain the outcomes data.
The sample size for the training set:
- Not found in the document. Since it's a mechanical device and not an AI/algorithm, the concept of a "training set" in the context of machine learning does not apply. If this refers to the data used to design or validate the device, no sample size for such a purpose is provided.
How the ground truth for the training set was established:
- Not applicable. (See point 8).

Conclusion:

The provided 510(k) summary is designed to establish substantial equivalence for a physical medical device (traction bed) based on its mechanical principles, safety features, and similarity to existing predicate devices. It does not contain the kind of detailed performance study data, acceptance criteria, or ground truth establishment methods typically associated with software, AI, or diagnostic devices. The references to "study papers" indicate published research was used to support the principle of decompression, but the specific performance of the DRS System™ against quantitative acceptance criteria is not presented within this document.

Summary

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Image /page/0/Picture/2 description: The image shows a date, "JUN 24 1998". The month is June, the day is the 24th, and the year is 1998. The text is in a bold, sans-serif font. The text is black on a white background.

Image /page/0/Picture/3 description: The image shows the logo for PDS, Professional Distribution Systems, Inc. The letters PDS are in a large, bold, sans-serif font. Underneath each letter are three horizontal lines. The words "PROFESSIONAL DISTRIBUTION SYSTEMS, INC." are in a smaller font below the letters.

K981822

company, trading symbol CLIT. PDS Inc. is a wholly owned subsidiary of Cluster Technology, Corp., a public

SECTION VII

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

[As required by 21 CFR 807.92]

Name of Manufacturer

Professional Distribution Systems, Inc. 1160 South Rogers Circle, Bldg. A Boca Raton, FL 33487 Tel: (561) 988-1747 / Fax: (561) 988-0967

David Williams, President & CEO Professional Distribution Systems, Inc. Tel: (561) 988-1747 / Fax (561) 988-9067

Date of Summary Preparation

May 21, 1998

Device Description

Contact Person:

Device Proprietary Name: Common Name: Classification Name: Class and Reference Product Code: Panel Code:

DRS System Traction Equipment Power Traction Equipment Class II (21 CFR Section 890.5900) 89ITH 87ORS

Predicate Devices:

K844385 Tru-Trac 401 Traction - Henley International K951622 VAX-D® Therapeutic Table - Vat-Tech, Inc.

Device Description

The DRS System™ is designed to apply distraction forces to a patient's lumbar spine.

The key elements are as follows:

The bed is a stand on/stand off tilt type bed that allows the fully clothed patient to 1. The bed is a stails on stail on the rype ood position. The bed and patient can then
Section VII, Page 1 of 5, Rev. A

1160 South Rogers Circle . Bldg. A . Boca Raton, Florida 33487 . 561-988-1747 . Fax 561-988-1749

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Professional Distribution Systems, Inc. DRS System™ - 510(k) Notification

SUMMARY OF SAFETY AND EFFECTIVENESS

be slowly lowered to the horizontal treatment position using a remote controller hand held by the practitioner.

Once in the horizontal position the bed can be raised or lowered to the practitioner's ﻨ preferred treatment height via the same hand held remote controller.
The bed is split into two cushions, each slideable in the horizontal plane only on low 3. friction runners and each being able to be locked independently.
Distraction tensions are applied to the patient via a pelvic harness while the upper ধ body of the patient is anchored to the locked upper (cephalic) cushion via a chest harness and adjustable underarm supports. The lower cushion, which is unlocked and on which the patient's lower trunk is rested, is able to slide easily thus reducing almost completely any frictional movement between patient and bed cushion when distraction tensions are applied, this concentrates virtually all the forces to the affected part of the lumbar spine.
The distraction unit (Vertrac) is mounted to a vertical movable platform incorporated র্বা into a support tower (Omni Tower) at the foot end of the bed. This enables the distraction tensions to be applied at differing angles to the patient (between 0 and 30 degrees).
1. The "Vertrac" unit is programmed and control panel fitted into the "Omni Tower" to give static or intermittent distraction.
1. The minimum and maximum distraction settings are 0-200 lbs ..
1. Treatment parameters i.e. tensions and time are continuously monitored and shown by LCD readout at the time of treatment set up and during treatment.
At the conclusion of treatment time, tension always returns to zero. ರ್.
1. A cassette player, which is incorporated in a separate section of the control panel, and wireless headphones together with an overhead fluorescent "black light" provide comfort and relaxation to the patient.
1. There is instantaneous release of all tensions if the patient pushes the button on the hand held Patient Safety Switch, or the Stop Button on the control panel has been pushed by the practitioner.
1. The DRS System™ will not operate if the Patient Safety Switch is not working properly or has not been tested prior to each treatment.
1. The treatment cannot be restarted when a patient activates the Patient Safety Switch or the Stop Button has been pushed during treatment unless all treatment parameters are manually re-entered into the controller.

Intended Use

The DRS System™ provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRS System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with hemiated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through

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Professional Distribution Systems, Inc. DRS System™ - 510(k) Notification

SUMMARY OF SAFETY AND EFFECTIVENESS

decompression of intervertebral discs, that is, unloading due to distraction and positioning.

Technological Characteristics

The DRS System™ incorporates various principles and working characteristics of the predicate devices, Tru-Trac 401 Traction Device (K844385) and the VAX-D Therapeutic Table (K951622). The incorporating of the traction device and a flat surface type powered bed, whilst giving a new overall appearance to the apparatus, has not impacted on or changed the safety of effectiveness of the devices.

Clinical trials carried out by VAX-D endorse the principle of decompression, however, enclosed are extracts from study papers carried out using The DRS System 14, which further confirms same. (See Bibliography on Page 5 of this Section.)

We will further confirm that this summary contains only information that is within the main body of the 510(k), and no unsubstantiated labeling, claims, raw data, trade secrets, or patient identification information.

Summary of Safety and Effectiveness

The principles of operation the DRS System™ are such that it permits the usefulness of effective distraction tensions to the lumbar spine. The more important safety features include:

1. The activation of pillars and actuators for the bed are via a 24-volt electrical circuit.
The control circuitry for the distraction unit including the power supply to the Patient 2. Safety Switch is a maximum 24 volts.
నా The patient is automatically reclined to the treatment position rather than climbing onto the treatment bed.
1. Adjustable handgrips are fitted for the patient to hold while the bed is being slowly reclined.
1. There is instantaneous release of all tensions when the button on the hand held Patient Safety Switch is depressed, the Stop Button is pressed on the control panel, or when electrical current is interrupted. The treatment program cannot be automatically restarted when any of those items in no. "5" have occurred without the full treatment parameters being manually re-entered into the control panel.
All treatment parameters must be manually entered each time a treatment occurs. 6.
1. There is a limited vertical movement of the traction box.
There is a permanent, visible means of indication of the angle of distraction pull. రం
There is an audible warning signal when the unit is first turned on, when the treatment の is completed, when the Patient Safety Switch is tested, when the Patient Safety Switch is activated during treatment, and when the entered treatment distraction parameter exceeds 39 lbs. force of tension.

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PAGE 09

SUMMARY OF SAFETY AND EFFECTIVENESS

The Tru-Trac 401 has been in use in this country for more than ten years and we have no evidence of a MDR report being filed by the manufacturer nor have we been made aware of any events or conditions effecting the operation of this equipment during all trials carried out by PDS.

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June 17, 1998

Professional Distribution Systems, Inc. DRS System™ - 510(k) Notification

SUMMARY OF SAFETY AND EFFECTIVENESS

Bibliography of Extracts from Study Papers Carried Out Using the DRS SYSTEM.

1. Shealy, C. Norman, and Borgmeyer, Vera (1997) Decompression, Reduction, and Stabilization of the Lumbar Spine: A Cost Effective Treatment for Lumbosacral Pain. American Journal of Pain Management, Vol. 7, p. 63-65.
1. Shealy, C. Norman, and LeRoy, Pierre L. (1998) New Concepts in Back Pain Management: Decompression, Reduction, and Stabilization. St. Lucie Press, Boca Raton, FL. Chapter 20, p. 239-257.

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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around the perimeter. To the right of the text is a symbol featuring a stylized human figure in profile, composed of three overlapping silhouettes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 24 1998

Mr. David Williams · President & CEO Professional Distribution Systems, Inc. 1160 South Rogers Circle, Building A Boca Raton, Florida 33487

K981822 Re: DRS System Trade Name: Requlatory Class: II Product Code: ITH May 21, 1998 Dated: Received: May 22, 1998

Dear Mr. Williams:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David Williams

This letter will allow you to begin marketing your device as This letter will allow you co begin motification. The FDA described in your 510(K) prematice of your device to a legally
finding of substantial equivalence of classification for vour finding of substancial equivatine of jolassification for your marketed predicate device resures in a classes.
device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling If you desire specific advice for gitionally 809.10 for in regulacion (21 cm rate over are contact the Office of
vitro diagnostic devices), please contact the for questio vitro diagnostic devices), predoc otionally, for questions on
Compliance at (301) 594–4659. Additionalize plaase contact Compliance at (301) 334 4037. India device, please contact
the promotion and advertising of your accommon the promotion and advertising or jour 4639. Also, please note the Office Of Compriand, "Misbranding by reference to the regulation entitled, "Misblanding my Dother general premation on your responsibilities under the Act may be information on your responsiblish of Small Manufacturers Assistance obtained from the Division or (301) 638-2041 or (301) 443-6597 or at at its coll-iree number (000)- 050-2007-05-28 11:51".
its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

J. Cole

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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June 17, 1998

Professional Distribution Systems, Inc. DRS System™ - 510(k) Notification

510(k) Number (if known): K981822

Device Name: DRS System

Indications For Use:

Intended Use

The DRS System provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRS System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc discase, posterior facer syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number be C981822

X Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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).