TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

Device Description

The CEFAR Primo is a handheld battery powered TENS device with two channels and nine preset stimulation programs. The two channels are separated and it is possible to stimulate with two different stimulation programs simultaneously, one on each channel. Program information and electrical current amplitude is displayed on a LCD. The user can set the amplitude in the range 0-60 mA for all programs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CEFAR Primo, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that the device had to meet. Instead, the "acceptance criteria" appear to be centered on demonstrating substantial equivalence to a predicate device and compliance with relevant safety standards.

The study presented focuses on demonstrating that the CEFAR Primo performs equivalently to the predicate device and adheres to safety regulations, rather than meeting specific quantifiable performance targets.

Characteristic	Acceptance Criteria (Implied by Predicate Comparison and Standards)	Reported Device Performance (CEFAR Primo)
Indications for Use	Must be identical or substantially similar to the predicate device to ensure equivalent intended medical purpose.	Identical to predicate device: "Used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision."
Safety Standards Compliance	Must comply with relevant international electrical safety and electromagnetic compatibility (EMC) standards for medical devices (IEC EN 60601-1-2, IEC EN 60601-1, and IEC EN 60601-2-10). The device must not present new safety concerns.	Successfully completed external testing, performed by Notified Body SEMKO AB, confirming compliance with IEC EN 60601-1-2 regarding EMC, IEC EN 60601-1 regarding general safety, and IEC EN 60601-2-10 regarding TENS device safety.
Functional Equivalence	Key functional characteristics (e.g., number of channels, open circuit detection, current delivery, display, power supply, output control, pulse form, and maximum parameters like amplitude, pulse width, and charge per pulse) must be comparable to the predicate device to ensure equivalent therapeutic effect and user experience. Some variations are acceptable if they do not raise new safety or effectiveness concerns.	Identical or comparable in: - Indications for use - Prescription device - Number of channels (2) - Open circuit detection (Yes) - Transcutaneous current delivery (Yes) - LCD display (showing intensity & program) - Power supply (battery operated) - Software controlled output (Yes) - User control of output (push buttons) - Pulsed output (Yes) - Pulse form (Asymmetric biphasic, zero net DC) - Max amplitude (60 mA) - Max pulse width (180 µs vs 300 µs for predicate) - Max charge per pulse (10.8 µC vs 18 µC for predicate) Differences noted but deemed acceptable: - Specific preset stimulation programs/parameters (e.g., continuous, burst, modulated pulse duration, mixed frequency) offer different specific settings but are within the general functional scope of a TENS device.
(Implied) No New Concerns	The device must not raise any new questions of safety or effectiveness compared to the predicate device.	Conclusion: The CEFAR Primo "presents no new concerns about safety and effectiveness."

Study Information

The document describes a bench testing and comparison study rather than a clinical trial or a study involving human readers.

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "sample size" in the context of clinical data or image sets. The study involved in-house system validation and external testing against technical standards. It's an assessment of the device's physical and electrical properties, not its performance on patient data.
- Data Provenance: Not applicable, as it's a technical validation of a physical device against standards, not data-driven performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable in the sense of clinical experts establishing ground truth for diagnostic accuracy since this is a TENS device subject to technical safety and performance standards.
- Qualifications: The "experts" involved would be the engineers and technicians at CEFAR Medical AB for in-house validation, and the testing personnel at SEMKO AB (ID 0413), a Notified Body, for external compliance testing. Their qualifications would be in electrical engineering, medical device safety, and regulatory compliance.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling expert opinions on clinical ground truth. This study relies on objective measurements against engineering standards.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done, but not in the context of an algorithm. The "standalone" performance here refers to the device's intrinsic functional and safety characteristics as measured against technical standards, independent of human interaction beyond normal operation. The device itself (the "algorithm only") was tested for its electrical output, safety features, and compliance with regulations.
The type of ground truth used:
- The "ground truth" for this regulatory submission is defined by international medical device safety and performance standards (IEC EN 60601-1-2, IEC EN 60601-1, IEC EN 60601-2-10) and the functional characteristics of the predicate device (SMP-PLUS K982410 TENS-stimulator Rehabilicare). The device's measurements and functionalities were compared against these established technical benchmarks and the predicate device's specifications.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary

{0}------------------------------------------------

APPENDIX I. SUMMARY AND CERTIFICATION

APPENDIX I A. 510(K) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the CEFAR Medical AB summary for the CEFAR Primo:

SUBMITTER'S NAME:	CEFAR Medical AB
ADDRESS:	Scheelevagen 19F
	SE-223 70 Lund
	Sweden
CONTACT PERSON:	Constance Bundy
TELEPHONE NUMBER:	763-574-1976
FAX NUMBER:	763-571-2437
DATE OF SUBMISSION:	11 March 2002

1. Identification of device

Proprietary Name: CEFAR Medical AB CEFAR Primo Common Name: Transcutaneous electrical nerve stimulator for pain relief (TENS) Classification Status: Class II per regulations 882.5890 Product Codes: GZJ

2. Equivalent devices

CEFAR Medical AB believes the CEFAR Primo is substantially equivalent to:

SMP-PLUS K982410 TENS-stimulator Rehabilicare

3. Description of the Device

Program information and electrical current amplitude is displayed on a LCD. The user can set the amplitude in the range 0-60 mA for all programs.

4. Intended use

The CEFAR Medical AB CEFAR Primo is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

{1}------------------------------------------------

ડ. Comparison to predicate device.

Comparison table

Characteristic	SMP-PLUS(Predicate device)	CEFAR Primo
Indications for usestatement	Identical	See Section 1 B Indications forUse Statement
Prescription device	Yes	Yes
Number of channels	2	2
Open circuit detection	Yes	Yes
Transcutaneous currentdelivery	Yes, through electrodes placedon patients body	Yes, through electrodes placedon patients body
LCD dislay	Yes, showing applied intensityin mA and stimulation mode	Yes, showing applied intensityin mA and stimulationprogram
Power supply	Yes, battery operated 9V	Yes, battery operated 2x1.5 V
Software controlledoutput	Yes	Yes
Continous stimulation	Yes, user set rate 2-125 Hzand 40-300 $ \mu $ s	Yes, preset 80 Hz and 180 $ \mu $ s,10 Hz and 180 $ \mu $ s and 80 Hzand 60 $ \mu $ s
Burst	Yes, 8 pulses per burst 2 burstsper second	Yes, 8 pulses per burst 2 burstsper second
Modulated pulseduration	Yes, 60% of set pulse width tousers set pulse width 40-300 $ \mu $ s	Yes, 70 -180 $ \mu $ s
Mixed frequency	Yes, alternates 60% of setfrequency to users setfrequency 2-125 Hz every 2.5seconds	Yes, 2 Hz burst for 3 secondsand 15 Hz or 80 Hz continuousfor 3 seconds
User control of output	Yes, push buttons	Yes, push buttons
Pulsed output	Yes, 2-125 Hz	Yes, 2-120 Hz
Pulse form	Asymmetric biphasic, zero netDC	Asymmetric biphasic, zero netDC
Maximum amplitude	60 mA	60 mA
Maximum pulse width	300 $ \mu $ s	180 $ \mu $ s
Maximum charge perpulse	18 $ \mu $ C	10.8 $ \mu $ C

Discussion of functional and safety testing. 6.

An extensive collection of tests has been conducted and successfully completed, including system validation in-house and external testing to show compliance with IEC EN 60 601-1-2 regarding EMC, IEC EN 60601-1 regarding general safety for medical equipment and IEC EN 60601-2-10 regarding general safety for medical equipment TENS devices.

Notified body SEMKO AB, with ID 0413, has performed the external testing.

{2}------------------------------------------------

7. Conclusion

Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of CEFAR Medical AB that the CEFAR Primo is substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

3/3

{3}------------------------------------------------

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 features a stylized eagle or bird symbol, with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

JUN 1 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mrs. Constance G. Bundy CEFAR Medical AB C/O: C.G. Bundy and Associates, Inc. 6740 Riverview Terrace Minneapolis, Minnesota 55432

Re: K020803

Trade/Device Name: CEFAR Primo Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: March 11, 2002 Received: March 12, 2002

Dear Mrs Bundy:

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. This letter will allow you to begin marketing your device as described in your Section 510(k)

{4}------------------------------------------------

Page 2 - Mrs. Bundy

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Milkenen

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

{5}------------------------------------------------

Page 1 of 1

B. INDICATIONS FOR USE

510(k) Number K020803

Device Name: CEFAR Primo

Indications for Use:

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use

for Mark N. Mikkelsen
(Division Sign Off)

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

510(k) Number K030803

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).