The Chronic Pain Suppressor CPS-2000 is a rechargeable battery operated Interferential Current Therapy device that utilizes an output circuit to generate a symmetric monophasic sine or square waveform of electrical current. Delivered along a patient cable and lead wires to electrodes placed on the skin. The physician prescribed and programmed output passes through the skin and actives the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.

AI/ML Overview

Here's an analysis of the provided text regarding the Chronic Pain Suppressor CPS-2000's acceptance criteria and studies, based on the information available:

The provided document is a 510(k) summary for the Chronic Pain Suppressor CPS-2000. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the way an AI/ML device submission would.

Therefore, many of the requested sections about specific performance metrics, sample sizes, expert involvement, and ground truth are not applicable to this type of traditional medical device submission. The device is an Interferential Current Therapy device, not an AI/ML diagnostic tool.

Analysis of Acceptance Criteria and Supporting Study for Chronic Pain Suppressor CPS-2000

The provided 510(k) summary (K033358) for the Chronic Pain Suppressor CPS-2000 focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than presenting a performance study against specific, quantitative acceptance criteria for clinical efficacy. The "acceptance criteria" here are implicitly related to meeting the standards of general safety and effectiveness comparable to existing devices of its type, as established through compliance with voluntary standards and descriptive characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Safety and Effectiveness: Demonstrate safety and effectiveness comparable to legally marketed predicate devices.	Substantial Equivalence Claim: The Chronic Pain Suppressor CPS-2000 is claimed to be "as safe and effective, and performs as well as the predicate devices."Specific Aspect: Compliance with voluntary standards (UL 60601-1, IEC 60601-1-2, AAMI/ANSI NS4:1986/(R)2002 items) for electrical safety, electromagnetic compatibility, and Transcutaneous Electrical Nerve Stimulator requirements (where applicable to Interferential Current Therapy devices).
Functional Equivalence: The device should perform its intended function in a similar manner to predicate devices.	Description: Utilizes an output circuit to generate a symmetric monophasic sine or square waveform of electrical current, delivered via electrodes to activate underlying nerves for symptomatic relief of chronic intractable pain and adjunctive treatment for post-traumatic/post-surgical pain. This description aligns with the general function of Interferential Current Therapy devices.
"Patient-Lock" Feature Safety/Effectiveness: Any new features should not adversely affect safety or effectiveness.	Assessment: The "Patient-Lock" feature, which protects physician-programmed treatment parameters from alteration by the patient (allowing only initiation/stopping, intensity adjustment, and viewing countdown), is stated to "in no way affect the safety or effectiveness of the device." In fact, it is claimed that "safety is raised as the prescribed treatment parameters programmed by the physician are protected from alteration."
Conformance to Applicable Voluntary Standards: Adherence to recognized medical device standards for design and manufacturing.	Conformance Documentation: The device conforms to: - UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety - IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests - AAMI/ANSI NS4:1986/(R)2002 Transcutaneous Electrical Nerve Stimulators (specifically items 3.1-3.1.2.1, 3.1.3-3.2.5, 4.1-4.2.3.2) - Note: While the device is an Interferential Current Therapy device, certain aspects of TENS standards may be considered relevant for electrical stimulation safety and performance characteristics.

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

Not Applicable (N/A) for clinical test set: This 510(k) summary does not describe a clinical performance study with a "test set" of patients in the context of typical clinical trial data submission for an AI/ML device. The evidence for substantial equivalence relies on descriptive characteristics and conformance to voluntary standards rather than new clinical data from a specific patient cohort.
Data Provenance: N/A.

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

N/A: No clinical test set requiring expert-established ground truth is described in this 510(k) summary. The submission relies on regulatory and engineering specialists confirming compliance with standards and comparing technical specifications to predicate devices.

4. Adjudication Method for the Test Set

N/A: No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No: An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. Such studies are typically for diagnostic devices or AI/ML-assisted interpretation, which is not the nature of the Chronic Pain Suppressor.

6. If a Standalone Performance Study Was Done

Standalone (Technical) Performance: Yes, in the sense that the device's technical specifications and safety characteristics were evaluated for conformance to voluntary standards (UL, IEC, AAMI/ANSI NS4). This demonstrates the device's ability to operate safely and within expected electrical parameters. However, this is not a "standalone clinical performance" study for diagnostic accuracy or clinical efficacy against a novel endpoint.
Results: The device was found to conform to the specified voluntary standards, indicating its technical safety and performance meet recognized benchmarks.

7. The Type of Ground Truth Used

N/A (for clinical ground truth): The "ground truth" here is conceptual, relating to the established technical requirements and safety parameters defined by the voluntary standards (e.g., electrical output specifications, electromagnetic compatibility limits, safety features). There is no "pathology" or "outcomes data" ground truth established for a clinical cohort.

8. The Sample Size for the Training Set

N/A: There is no "training set" as this is not an AI/ML device.

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

N/A: There is no "training set," so the concept of establishing ground truth for it is not applicable.

Summary

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NOV 1 4 2003

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically the string 'K033358'. The characters are written in a bold, sans-serif font, and they appear to be handwritten or generated with a slightly rough edge. The sequence consists of an uppercase 'K' followed by six numerical digits.

8.0 Chronic Pain Suppressor CPS-2000 510(k) Summary (as required by section 807.92(c))

Submitter's Name:	SurgiTech, Inc.2424 Vista Way, Suite 300Oceanside, CA 92054
Contact Person:	Chris CrowellPhone: (760) 450-0194Fax: (760) 721-4290
Date Prepared:	October 10, 2003
Trade or Proprietary Name:	Chronic Pain Suppressor
Common or Usual Name:	Interferential Current Therapy
SurgiTech Model Number:	CPS-2000
Establishment Registration Number:	2032724
Device Class:	II
Classification Name:	Interferential Current Therapy
CFR #:	Unclassified
Product Code:	LIH

Description of Device:

Intended Use:

The intended uses of the Chronic Pain Suppressor are:

Symptomatic relief of chronic intractable pain
Adjunctive treatment for the management of post-traumatic or post-surgical pain .

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Predicate Device Information:

Device	Applicant	510(k) #
SD-730	Skylark Device	K992652
HMP 4000	HMP 4000, Inc.	K924961

Substantial Equivalence:

The Chronic Pain Suppressor CPS-2000 is equivalent in basic form and function to almost any other Class II Interferential Current Therapy device. A difference to the legally marketed predicate devices is the "Patient-Lock" feature. This difference in no way affects the safety or effectiveness of the device. Ultimately, the safety is raised as the prescribed treatment parameters programmed by the physician are protected from alteration. The patient may only initiate and stop treatment at designated time intervals, adjust the intensity, and view the session countdown timer for the next treatment.

Performance Data:

The descriptive characteristics presented are thorough to ensure the substantial equivalence of the Chronic Pain Suppressor CPS-2000 to the legally marketed predicate devices. The descriptive characteristics include the data provided in the Substantial Equivalence Comparison Table within this premarket notification submission.

Conformance to Voluntary Standards:

UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for . Safety
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for . Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
AAMI/ANSI NS4:1986/(R)2002 Transcutaneous Electrical Nerve Stimulators -● specifically items 3.1-3.1.2.1, 3.1.3-3.2.5, 4.1-4.2.3.2

Conclusion:

The Chronic Pain Suppressor CPS-2000 is as safe and effective, and performs as well as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

NOV 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christopher Crowell Ouality Assurance Manager SurgiTech, Inc. 2424 Vista Way, Suite 300 Oceanside, California 92054

Re: K033358

Trade/Device Name: Chronic Pain Suppressor CPS-2000 Regulatory Class: Unclassified Product Code: LIH Dated: October 10, 2003 Received: October 20, 2003

Dear Mr. Crowell:

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. Christopher Crowell

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" (21CFR 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,

Mark A. Milliken

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

Enclosure

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Page of of

510(k) Number:

Device Name: ___ Chronic Pain Suppressor CPS-2000

Indications for Use:

Symptomatic relief of chronic intractable pain. ●
Adjunctive treatment for the management of post-traumatic or post-. surgical pain.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Mark N. Milkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K033358
K033358

(Optional Format 3-10-98)

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).