The SpineMED® System provides a program of treatments for relief from pain for those patients suffering with low back pain, neck pain or sciatica. Each treatment session consists of a physician prescribed treatment period on the SpineMED™ and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain, neck pain or sciatica. It relieves pain associated with herniated discs, bulging or 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 SpineMED® is a multi-function Hi-Lo traction table designed to apply distraction forces to a patient's spine (Lumbar and Cervical). The powered Hi-Lo adjustments of the table surface height are designed to provide easier loading and unloading of the patient on and off the table. Maximum lift capacity and weight bearing capacity is 4001bs.

The patient lies in a supine position on the table with the legs supported with a removable knee bolster. For increased comfort during the distraction, and to provide relaxed distraction of paraspinal tissue, an infrared heating pad is incorporated into the table surface directly beneath the lumbar area. This 12 Vdc infrared element can be turned on or off during the treatment.

The upper body is restrained through a chest harness, which is then attached to the fixed upper section of the table with a mechanical safety release buckle. The lower body is restrained to the moveable lower section of the table though pelvic restraints that are designed to capture and secure the patient's iliac crest.

The removable pelvic restraints are supplied in two sizes, to accommodate different patient sizes, and are removed from the table for patient loading. The pelvic restraints are adjusted laterally to fit patient's widths through an acme screw assembly incorporated into the tilting lower section. Turn handles are attached to the acme screw on either side of the table, and allow for uniform movement of the pelvic restraints together and apart, for an operator controlled comfortable fitting to the patient.

The table is a split-table design, whereby distraction tensions are applied to the patient through the pelvic restraints during the separation of the table. The lower table section is powered by a computer-controlled 24 VDC actuator, which separates the two table sections to a maximum of eight inches. The distraction tensions and rates are continuously monitored and measured by load cells, which transfer this information to the integrated computer. A similar setting is present for the cervical setup. On top half of the split-table a cervical unit is attached, which applies tension to the high end of the spine. This unit is controlled by a 24 VDC actuator, which is controlled by the main computer. Information from the actuator is sent to the computer which displays the tension applied during the cervical treatment.

An incorporated battery backup system provides adequate system power to continue full operation of the SpineMED® in event of power failure, allowing safe continuation of treatment session. For safety, the patient is provided with an electrical hand-held patient safety switch, which when depressed, immediately interrupts the treatment session and gradually eliminates the application of force to zero under a controlled rate. A secondary safety device incorporates a mechanicallyoperated buckle for the upper harness, which the patient can control its release by simply pulling a switch integrated in the side of the table. The switch releases all distraction forces to the patient.

All treatment parameters and data are captured on the LCD screen and can be printed out to a printer and are stored electronically in the database. There are no new potential flammable materials used in the S200B/C. All material remain the same as the original 510k submission of the S100A(K030060).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SpineMED® S200B/S200C device. The document focuses on demonstrating substantial equivalence to predicate devices and detailing the device's design and basic safety testing.

However, the document does not contain information regarding specific acceptance criteria for device performance in a clinical or diagnostic context, nor does it describe a study proving the device meets such criteria through metrics like sensitivity, specificity, accuracy, or reader performance. The content is primarily focused on regulatory submission requirements for a medical device that performs powered traction.

Therefore, for most of the requested information regarding acceptance criteria and performance studies, the answer will be that the information is not present in the provided text.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Provided: The document does not specify performance acceptance criteria in terms of clinical or diagnostic outcomes (e.g., pain reduction percentages, success rates, or specific physiological changes). It refers to the device's intended function (applying distraction forces to relieve pressure) but not measurable performance against a benchmark.

The document states:

"Testing was performed to validate the functional performance of the SpineMED system. In particular, specific performance testing of the software was performed to show that the performance was met."
"The SpineMED S200B/C has been subjected to performance testing to applicable safety, electrical, mechanical. EMC standards."

These statements indicate functional and safety testing, but not clinical performance data or acceptance criteria for such data.

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

Information Not Provided: No information is given about a "test set" in the context of clinical or diagnostic performance. The document describes functional and safety testing for the device itself, not a study involving human subjects or data sets of patient outcomes.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Information Not Provided: Since no clinical or diagnostic performance study is described with a "test set," there's no mention of experts establishing ground truth for such a study.

4. Adjudication Method for the Test Set

Information Not Provided: As no test set for clinical/diagnostic performance is described, there's no adjudication method mentioned.

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

Information Not Provided: The document does not describe an MRMC study or any study involving human readers or AI assistance. The device is a physical powered traction equipment, not an AI or diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance Study

Information Not Provided: The device is traction equipment; there is no mention of an algorithm-only performance study.

7. Type of Ground Truth Used

Information Not Provided: The document focuses on the mechanical and electrical safety and functional operation of the device. The "ground truth" referenced implicitly relates to compliance with engineering standards (IEC, UL, CAN/CSA) and internal functional test procedures for the device, rather than a clinical ground truth for diagnostic or treatment efficacy.

8. Sample Size for the Training Set

Information Not Provided: There is no mention of a "training set" in the context of machine learning or algorithm development, as the device is mechanical traction equipment.

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

Information Not Provided: No training set is mentioned, thus no ground truth establishment for it.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (powered traction equipment) to existing devices based on indications for use, design characteristics, components, size, power source, and performance in terms of safety and functional operation (e.g., software performance). It does not contain the kind of performance study data or acceptance criteria typically associated with diagnostic AI or imaging devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ERT Health Sciences, LLC, with the letters "ERT" inside of a circle with an arrow. The text "Health Sciences, LLC" is to the right of the logo. The date "APR 27 2005" is in the upper right corner of the image.

510(k) Summary of Safety and Effectiveness

Company Name:	CERT HEALTH SCIENCES, LLC10440 Little Patuxent Parkway, #300Columbia, Maryland 21044Telephone: (866) 990-4444Fax: (866) 990-4445
Contact Person:	Mr. Tim EmskyCERT HEALTH SCIENCES, LLCTelephone: 1-866-990-4444Fax: 1-866-990-4445Email: [emsky@certhealthsciences.com]
Date of Summary:	January 28, 2005
Trade Name:	SpineMED® S200B/S200C
Common Name:	Powered Traction Equipment
Classification Name:	Powered Traction Equipment
Class and Reference:	Class II (21 CFR Section 890.5900)
Product Code:	ITH
Panel Code:	87ORS
Regulation Number:	890.5900

Predicate Devices:

We are making the claim that the SpineMED® S200B/S200C is substantial equivalent to the predicated devices listed in the chart below.

LEGALLYMARKETEDPREDICATE DEVICE	MANUFACTURENAME	REGULATORYCLASS ANDPRODUCTCODE	510(K)REGISTRATIONNUMBER
3D Activetrac	The SaundersGroup-	Class II/ITH	K001712
DRX5000	AXIOM USA Inc	Class II/ITH	K023160

The rationale of declaring the SpineMED S200B/C is substantial equivalent to the above 2 predicate devices are based on the following:

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Same Indications for use: All systems provide treatments for relief of pain associated with > low back pain, neck pain and sciatica. The treatment consists of a physician prescribed treatment period in which static, intermittent, and cycling distraction forces are applied to relieve pressures on structures that are causing low back pain, neck pain and sciatica.
Similar key design technical characteristics- Multi-function table designed to applied > distraction forces and controlled by a computer console.
Same/similar components for treatment and measurement.
Similar size, power source, and performance

Device Description:

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Image /page/2/Picture/1 description: The image shows the logo for "Health Sciences, LLC". The logo consists of a stylized letter "C" that wraps around the letters "ERT". To the right of the logo is the text "Health Sciences, LLC" in a simple, sans-serif font. The logo is clean and professional, suggesting a company in the healthcare or scientific field.

computer. Information from the actuator is sent to the computer which displays the tension applied during the cervical treatment.

Indications for Use:

Summary of Performance Testing:

A risk analysis identifying potential hazards and documenting mitigations of the hazards has been developed and applied as part of the SpineMED S200B/C product development cycle. The risk analysis is based on EN 1441/ISO14971 - Risk Analysis for Medical Devices.

Testing was performed to validate the functional performance of the SpineMED system. In particular, specific performance testing of the software was performed to show that the performance was met. Testing is in accordance to the 'SpineMED Test Procedure Checklist' prior to any production units shipped to the end customer.

The SpineMED S200B/C has been subjected to performance testing to applicable safety, electrical, mechanical. EMC standards. The SpineMED S200B/C system has been evaluated and has passed all mechanical and electrical safety according to CSA International. Standards that were investigated are: IEC 60601-1, UL 60601-1 and CAN/CSA C22.2No.601.1-M90 certified

Conclusion:

As stated above, CERT Health Sciences's conclusion is that the SpineMED S200B/C is safe and effective and complies with the appropriate medical standards and is substantially equivalent to the above identified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2005

ﯿﻢ

CERT HEALTH SCIENCES, LLC c/o Mr. Tamas Borsai TUV Rheinland of North America, Inc. 12 Commerce Road Newton, Connecticut 06470

Re: K051013

Trade/Device Name: SpineMED® S200B/S200C Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: April 14, 2005 Received: April 21, 2005

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section > Fo(x) prematice is substantially equivalent (for the indications felerenced above and nave decemined we are and a marketed predicate devices marketed in interstate for use stated in the encrosure) to regars names date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the enated with the provisions of the Federal Food, Drug, devices mall have been reclassified in acceracy of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The You may, mercrore, market the devices, equirements for annual registration, listing of general controls provisions of the Free Hebeling, 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 (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of D may be subject to sach additional controller Lineang of Shipany of Sheen of Sheep. In addition, FDA may be found in the Cour of Peach Boncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dris issuated on a device complies with other requirements of the Act that TDA has made a dolormination as administered by other Federal agencies. You must of any Federal statutes and regalations and limited to: registration and listing (21 comply with an the Act 31equirements, n.c., and manufacturing practice requirements as set CFR Part 807), adomig (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. Thomas Borsai

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin mancing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your dev premarket nothication. The PDA midning of backlands of 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 Patt 801), please If you desire specific advice for your ac not on one one note the regulation entitled, contact the Office of Compliance at (210) 276 - 16 - 16 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1 " Misbranding by reference to premance notifications in the Act from the Division of Small
on of Small other general information on your responsion in total free number (800) 638-2041 or 1941)
Manufacturers, International and Consumer Assistance at its to blind as thind Manufacturers, International and Consumer Assistance article of the new carbindex.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting 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):

Device Name:

SpineMED® S200B/S200C

Indications For Use:

The SpineMED® System provides a program of treatments for relief from pain for those patients suffering with low back pain, neck pain or sciatica. Each treatment session consists of a physician prescribed treatment period on the SpineMED™ and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain, neck pain or sciatica. It relieves pain associated with herniated discs, bulging or row unling 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.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Office Dental, Restorative
Dental, Herrological Devices
K051013

Proprietary to Cert Health Sciences LLC

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).