The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are symmetrical biphasic neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. Intended uses include:

Relaxation of muscle spasms .
Prevention or retardation of disuse atrophy -
Increasing local blood circulation -
Muscle re-education -
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion

Device Description

The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are battery powered handheld Neuro-Muscular Electrical Stimulation (NMES) devices only to be used under medical supervision for adjunctive therapy of medical diseases and conditions. The devices operate with two channels and 22 preset stimulation programs. On the CEFAR REHAB 2 PRO the user also can set parameters to create user defined stimulation programs.
Program information and amplitude is displayed on a LCD. The user can set the amplitude in the range 0-100 mA for all programs.

AI/ML Overview

The provided document, a 510(k) summary for the CEFAR REHAB 2 and CEFAR REHAB 2 PRO devices, does not contain information regarding specific acceptance criteria, a detailed study proving device performance against such criteria, or any of the specific points requested (sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone algorithm performance).

The document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and general safety/EMC testing, rather than a clinical performance study with defined acceptance criteria.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document does not provide a table with specific acceptance criteria or quantitative performance metrics for the device's intended uses (e.g., a specific percentage of muscle spasm reduction or improvement in range of motion).

The comparison table provided focuses on technical specifications to demonstrate equivalence:

Characteristic	Ortho DX (Predicate device)	CEFAR REHAB 2 and CEFAR REHAB 2 PRO
Indications for use statement	Identical	See Section 1 B Indications for Use Statement
Prescription device	Yes	Yes
Number of channels	2	2
Output	0-100 mA	0-100 mA
Wave form	Symmetrical biphasic rectangle with zero net DC	Symmetrical biphasic rectangle with zero net DC
Pulse width	0-300 $ \mu $ s	50-300 $ \mu $ s
Maximum charge per pulse	30 $ \mu $ C	30 $ \mu $ C
Pulse rate	33.3 Hz, fixed	2-120 Hz, fixed in each preset program
Transcutaneous current delivery	Yes, through electrodes placed on patients body	Yes, through electrodes placed on patients body
User control of output	Yes, knobs	Yes, pushbuttons
Power supply	Yes, battery operated 4xAA batteries (rechargeable or alkaline)	Yes, battery operated 2xAA batteries (rechargeable or alkaline)

Note: This table compares features, not performance against clinical acceptance criteria.

2. Sample size used for the test set and the data provenance

Missing. The document states "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." However, these are general safety and electromagnetic compatibility standards, not clinical performance studies. There is no mention of a clinical test set, sample size, or data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing. Since no clinical test set or ground truth establishment is described, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing. This information pertains to a clinical study with ground truth established by experts, which is not described.

5. 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

Not applicable. The CEFAR REHAB 2 and REHAB 2 PRO are Neuro-Muscular Electrical Stimulation (NMES) devices, not AI-powered diagnostic or assistive tools. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an NMES device with no described AI algorithm component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Missing. As no clinical performance study is detailed, no ground truth type is specified. The assessment focuses on the device's technical specifications and compliance with general medical device safety standards.

8. The sample size for the training set

Not applicable. This device does not use an AI algorithm that would require a training set.

9. How the ground truth for the training set was established

Not applicable. This device does not involve a training set for an AI algorithm.

In summary: The provided 510(k) summary demonstrates substantial equivalence based on a comparison of device characteristics and compliance with general safety and EMC standards. It does not include details of a clinical performance study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement as would be typical for a device requiring such evidence for performance claims. This is common for predicate pathway 510(k) submissions where the new device is functionally very similar to an already cleared device and does not raise new questions of safety or effectiveness.

Summary

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K030403

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APPENDIX I. 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 REHAB 2 and REHAB 2 PRO:

SUBMITTER'S NAME:	CEFAR Medical AB
ADDRESS:	Scheelevagen 19ASE-223 70 LundSweden
CONTACT PERSON:	Constance Bundy
TELEPHONE NUMBER:	763-574-1976
FAX NUMBER:	763-571-2437
DATE OF SUBMISSION:	February 4, 2003

1. Identification of device

Proprietary Name: CEFAR REHAB 2 and REHAB 2 PRO Common Name: Powered muscle stimulator Classification Status: Class II per regulations 890.5850 Product Codes: IPF

2. Equivalent devices

CEFAR Medical AB believes the CEFAR REHAB 2 and REHAB 2 PRO is substantially equivalent to:

Powered Muscle Stimulator Ortho DX Rehabilicare K971542

3. Description of the Device

Program information and amplitude is displayed on a LCD. The user can set the amplitude in the range 0-100 mA for all programs.

4. Intended use

Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion

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5. Comparison to predicate device.

Comparison table

Characteristic	Ortho DX(Predicate device)	CEFAR REHAB 2 andCEFAR REHAB 2 PRO
Indications for use statement	Identical	See Section 1 B Indications forUse Statement
Prescription device	Yes	Yes
Number of channels	2	2
Output	0-100 mA	0-100 mA
Wave form	Symmetrical biphasic rectanglewith zero net DC	Symmetrical biphasicrectangle with zero net DC
Pulse width	0-300 $ \mu $ s	50-300 $ \mu $ s
Maximum charge perpulse	30 $ \mu $ C	30 $ \mu $ C
Pulse rate	33.3 Hz, fixed	2-120 Hz, fixed in eachpreset program
Transcutaneous currentdelivery	Yes, through electrodes placedon patients body	Yes, through electrodesplaced on patients body
User control of output	Yes, knobs	Yes, pushbuttons
Power supply	Yes, battery operated 4xAAbatteries (rechargeable oralkaline)	Yes, battery operated 2xAAbatteries (rechargeable oralkaline)

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.

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

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 REHAB 2 and CEFAR REHAB 2 PRO are substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the department's name around the perimeter. Inside the circle is a stylized image of three abstract shapes, possibly representing human figures or elements of health and well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2003

CEFAR Medical AB c/o Ms. Constance G. Bundy C.G. Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, MN 55432

Re: K030403

Trade/Device Name: CEFAR REHAB 2 and CEFAR REHAB 2 PRO Regulation Numbers: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: II Product Codes: IPF Dated: May 7, 2003 Received: May 12, 2003

Dear Ms. 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.

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Page 2 - Ms. Constance G. Bundy

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. Millerson

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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Page 1 of 1

1.B. Indications for Use KO30403 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Device Name: CEFAR REHAB 2 and CEFAR REHAB 2 PRO

Indications for Use:

Relaxation of muscle spasms .
Prevention or retardation of disuse atrophy -
Increasing local blood circulation -
Muscle re-education -
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion

(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 Mulkern
(Division Si

ision of Genera . Restorative dological f

510(k) Number K030403

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).