The SpineMED™ provides a program of treatments for relief from pain for those patients suffering with low back pain. 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 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. The powered High-Low adjustments of the Table surface height are designed to provide easier loading and unloading of the patient on and off the table. The patient lies in a supine position on the Table with the legs supported with a removable knee bolster. For increased comfort during 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 treatment if a patient finds the heat uncomfortable. The upper body is restrained through a chest harness, which is then attached to the fixed upper section of the Table, to a mechanical safety release buckle. The lower body is restrained to the moveable lower section of the Table through pelvic restraints that are designed to capture and secure the patient's iliac crest. The SpineMED™ System consists of two main components: (1) The Table; and (2) The Control Console. The control console provides the power and the computer control systems to drive the function of the unit, where the table is the functional component used for the treatment. Together, the components function as one unit. The Table is a split-table design, whereby distractions are applied to the patient through the pelvic restraints during the separation of the Table, resulting from the movement of the lower table section. The Pelvic Restraints are incorporated into a 10 inch section of the powered Lower Table section, which has a powered tilt function, that is designed to tilt the pelvis during treatment. This actuator driven tilting section has the ability to tilt the pelvis at a maximum of 25 degrees during treatment, to provide targeted treatment of specific spinal segments.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the SpineMED™ device and related FDA correspondence. It does not describe any acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity, or specific physical measurements).

Instead, this document focuses on establishing substantial equivalence to predicate devices for regulatory clearance. The "study" mentioned refers to clinical trials carried out by the DRS System (a predicate device), which support the principles of decompression and the efficacy of this modality, rather than a specific performance study for the SpineMED™ itself.

Therefore, most of the requested information cannot be extracted from this document, as it is not a clinical study report or a performance validation document for the SpineMED™ specifically.

Below is the information that can be inferred or directly stated from the provided text, with notes indicating where information is absent.

Acceptance Criteria and Study for SpineMED™ (K030060)

Based on the provided 510(k) Summary, specific acceptance criteria for device performance (e.g., analytical or clinical performance metrics) and a study conducted for the SpineMED™ device itself to demonstrate meeting these criteria are not described. The document primarily relies on the substantial equivalence principle, drawing upon the established efficacy and safety of predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (SpineMED™)	Notes
Not specified for SpineMED™'s performance.	Not specified for SpineMED™'s performance.	The document does not list specific acceptance criteria for the SpineMED™'s performance (e.g., in terms of force accuracy, distraction rates, or clinical outcomes). The focus is on safety features and functional equivalence to predicate devices.

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

Sample Size (Test Set): Not applicable. No performance study for the SpineMED™ is detailed in this document.
Data Provenance: Not applicable. The document refers to "Clinical trials carried out by the DRS System" (a predicate device) to support the general principles of decompression, not as a test set for the SpineMED™ itself. The country of origin and prospective/retrospective nature of those DRS System trials are not mentioned.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable. As no specific performance study for the SpineMED™ is detailed, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described for the SpineMED™ device.

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

Was an MRMC study done? No. This type of study (common for AI/imaging devices) is not mentioned or relevant for this mechanical traction device.
Effect size of human readers with/without AI assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only)

Was a standalone performance study done? No. This device is a physical traction table; it does not involve algorithms in the sense of AI or image analysis. Its operation is described as having "computer control systems to drive the function of the unit."

7. Type of Ground Truth Used (for any performance claim)

Not applicable for SpineMED™'s own performance. The document states that "Clinical trials carried out by the DRS System support the principles of decompression and the efficacy of this modality." This implies that the 'ground truth' or evidence of efficacy for the modality (spinal decompression) was established through clinical outcomes in studies of the predicate device. However, specific details about how that ground truth was established (e.g., pathology, outcomes data specific to the DRS trials) are not provided here.

8. Sample Size for the Training Set

Not applicable. The SpineMED™ is described as a powered traction table, not an AI or machine learning system that requires a "training set."

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

Not applicable for the same reasons as above.

Summary

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Summary of safety and effectiveness of the new device:

FEB 0 5 2003

age

K030060

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SpineMEDTM

Name of Company:	CERT Health Sciences, LLC11805B Coastal HWY, #9992Ocean City, MD 21842-2460Telephone: (866) 990-4444Fax: (866) 990-4445
Contact Person:	Tim R. Emsky, Managing PartnerCERT Health Sciences, LLCTelephone: (866) 990-4444Fax: (866) 990-4445
Date of Summary Preparation:	December 4, 2002
Device Proprietary Name:	SpineMED™
Common Name:	Powered Traction Equipment
Classification Name:	Powered Traction Equipment
Class and Reference:	Class II (21 CFR Section 890.5900)
Product Code / Panel Code:	891TH
Predicate Device	DRS SystemProfessional Distribution Systems, Inc.510(k): K981822

Device Description:

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K030060
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The patient lies in a supine position on the Table with the legs supported with a removable knee bolster. For increased comfort during 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 treatment if a patient finds the heat uncomfortable.

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

The SpineMED™ System consists of two main components: (1) The Table; and (2) The Control Console.

The control console provides the power and the computer control systems to drive the function of the unit, where the table is the functional component used for the treatment. Together, the components function as one unit.

The Table is a split-table design, whereby distractions are applied to the patient through the pelvic restraints during the separation of the Table, resulting from the movement of the lower table section. The Pelvic Restraints are incorporated into a 10 inch section of the powered Lower Table section, which has a powered tilt function, that is designed to tilt the pelvis during treatment. This actuator driven tilting section has the ability to tilt the pelvis at a maximum of 25 degrees during treatment, to provide targeted treatment of specific spinal segments.

Intended Use

The SpineMED™ provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment session consists of a physician prescribed treatment period on the SpineMED™ and is designed to provide static, intermittent, and cvcling distraction forces to relieve pressures on structures that may be causing low back 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.

Technological Characteristics

The SpineMED™ incorporates various principles and working characteristics of the predicate devices, the DRS System (K981822) and the SPINA System (K002260). The SpineMED™ employs a unique method of restraining the patient's body to the Table surface, which has not impacted on, or changed the safety or effectiveness of the device. Clinical trials carried out by the DRS System support the principles of decompression and the efficacy of this modality.

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K030060
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Summary of Safety and Effectiveness

The operating principles of the SpineMED™ Table permit the safe application of effective distraction tensions to the lumbar spine. The electrically operated energy source is constantly monitored and displayed by the internal computer. A Battery Backup System incorporated into the device, provides full operation of the device for 30 minutes in the event of a power failure. allowing for safe, uninterrupted treatment of the patient to the conclusion of the treatment session. 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. This safety feature, in combination with the battery backup, minimizes the occurrence of muscle spasm, which can be caused by the sudden release of all tensions to zero, through a power failure or complete disengagement of the energy source. A secondary safety system, which incorporates a mechanically-operated release buckle for the upper harness, allows the patient to control its release by simply pulling a lever integrated into the Table. Activating this release buckle results in the upper harness being disengaged from the Table, immediately eliminating all distraction forces to the patient.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2003

Cert Health Sciences, LLC c/o Heinz-Joerg Steneberg Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Road Newtown, CT 06470

Re: K030060

Trade/Device Name: SpineMED™ Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: January 21, 2003 Received: January 22, 2003

Dear Mr. Steneberg:

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 - Heinz-Joerg Steneberg

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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html .

Sincerely yours,

Mah M Milken

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

Enclosure

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STATEMENT OF INDICATION FOR USE

K030060 510(k) Number:

Device Name:

CERT Health Sciences, SpineMEDTM

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milkenn

Division Sign-Off Division of General. Restorative and Neurological Devices

10(k) Number K030060

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).