The Biomove 3000 is a portable, battery powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke. The controls of the device are simple to operate. It has only two main control knobs: one to set the gain of the EMG amplifier (sensitivity for picking up the residual electrical muscle signal) and one to set the level for the stimulation impulse to the muscles to be re-educated. The following parts are supplied with the system: 3-lead Patient Cable, re-usable electrodes (Biotrodes) and a belt for fastening the device to the body of the user. A 5-lead Patient Cable is optional.

AI/ML Overview

The provided text describes the Biomove 3000 System, a neuromuscular electrical stimulator. However, it does not include a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size of human improvement.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices cleared by the FDA. This regulatory pathway means that the device is considered safe and effective because it is similar to devices already on the market, rather than requiring new clinical performance studies with acceptance criteria and statistical analysis.

Here's a breakdown based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., Performance Metrics)	Reported Device Performance
Specific performance criteria (e.g., accuracy, sensitivity, effect size on human readers) are not provided in this document.	The document states "Safety and performance testing" and "Comparative Testing" were performed, but does not detail the nature of these tests, specific acceptance criteria, or quantitative performance results for the device itself. Instead, it relies on substantial equivalence to predicate devices.

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

Not Applicable / Not Provided. The document does not describe a clinical study with a "test set" in the context of independent verification of performance metrics. The submission is based on substantial equivalence, implying that no new primary clinical performance data was required to be submitted for evaluation beyond what's inherent in the predicate devices.

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

Not Applicable / Not Provided. No new clinical study requiring ground truth establishment by experts is described for this submission.

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

Not Applicable / Not Provided. No new clinical study requiring adjudication is described for this submission.

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

No. This device is a muscle stimulator, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant to this device and was not conducted.

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

Not Applicable. This device is a physical muscle stimulator, not an algorithm, so the concept of "standalone performance" in the context of AI is not relevant.

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

Not Applicable / Not Provided. As no new performance study requiring ground truth is described, this is not relevant. The basis of approval is substantial equivalence to legally marketed predicate devices, implying their safety and effectiveness have already been established.

8. The sample size for the training set

Not Applicable / Not Provided. This device does not use machine learning or AI that would require a "training set."

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

Not Applicable / Not Provided. As no training set is relevant, no ground truth establishment for it is described.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided document does not describe a new clinical study with specific acceptance criteria and detailed performance results for the Biomove 3000 System. Instead, the device's clearance is based on substantial equivalence to two predicate devices: the NeuroMove NM900 (K012885) and the AutoMove, Model AM800 (K032955).

The claim of equivalence is supported by:

The Biomove 3000's intended use and indications for use are identical to those previously cleared for the predicate devices.
The technical characteristics of the Biomove 3000 are similar to those of the predicate devices.
"Safety and performance testing" and "Comparative Testing" were conducted, but the details of these tests, specific methodologies, sample sizes, or quantitative results are not provided in this summary. The focus is on demonstrating that these tests confirm similarity to the predicates, rather than proving performance against novel, pre-defined acceptance criteria.
Compliance with recognized electrical safety and medical device standards (IEC 60601-1, IEC 60601-2-10) and FDA guidance documents for powered muscle stimulators.

The FDA's decision to clear the device (K042650) confirms that the agency found the Biomove 3000 System to be substantially equivalent to its predicate devices, meaning it raises no new safety and/or effectiveness issues. Therefore, the "study" proving the device meets acceptance criteria is, in this context, the demonstration of its substantial equivalence to already cleared devices based on comparison of intended use, technological characteristics, safety data, and general performance observations, rather than a new, detailed clinical trial with specific performance endpoints.

Summary

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

510(K) SUMMARY

Biomove 3000 System

510(k) Number K042650

A. Applicant's Name: Curatronic Ltd. 4 Atsmon Street. Hashmonaim 73127, Israel Tel.:+972-8-9761441 Fax .: +972-8-9762020 e-mail: philipson@curatronic.com
B. Contact Person: Arava HaCohen, RAC A. Stein - Regulatory Affairs Consulting 20 HaTa'as St. Kfar Saba 44425 Israel Tel. + 972-9-7670002 Fax. +972-9-7668534
C. Date Prepared: September 2004
D. Trade Name: Biomove 3000 System (also known as the Curamove 3000 System outside of the US)
E. Classification: Name: stimulator, muscle, powered Product Code: IPF Regulation No: 890.5850 Class: II Panel: Physical Medicine
F. Predicate Devices: The Biomove 3000 is substantially equivalent to the NeuroMove NM900 device (Dan Med, Inc.) cleared under K012885 in terms of intended use, indications for use, technological characteristics, performance and user interface.

In addition, the Biomove 3000 is substantially equivalent to the AutoMove, Model AM800 (Danmeter A/S) cleared under K032955 in terms of intended use, indications for use, technological characteristics, performance and user interface.

Both predicate devices are Class II medical devices.

A discussion of substantial equivalence is provided in Section 3 of this submission.

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

G. Device Description:

The Biomove 3000 is a portable, battery powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke.

The controls of the device are simple to operate. It has only two main control knobs: one to set the gain of the EMG amplifier (sensitivity for picking up the residual electrical muscle signal) and one to set the level for the stimulation impulse to the muscles to be re-educated.

The following parts are supplied with the system: 3-lead Patient Cable, re-usable electrodes (Biotrodes) and a belt for fastening the device to the body of the user. A 5-lead Patient Cable is optional.

H. Intended Use / Indication for Use:

The Biomove 3000 is indicated for:

1.	Stroke Rehabilitation by Muscle Re-education
----	----------------------------------------------

1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. Muscle re-education
1. Maintaining or increasing range of motion

I. Performance Standards:

The Biomove 3000 complies with U.S. Federal Performance Standard as set forth in 21 CFR 898 for electrode lead wires and Patient Cables.

The device complies with the following recognized standards:

IEC 60601-1(1988), including amendments #1(1991), . #2(1995)
IEC 60601-2-10 (1987) .

The device complies with the Guidance Document for Powered Muscle Stimulator 510(k)s; Final (1999).

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

J. Substantial Equivalence:

There are no unique applications, indications, materials or specifications presented below. Evidence of equivalence has been demonstrated through:

The Biomove 3000 intended use and indications for use were . previously cleared by FDA for the predicate devices.
The technical characteristics of the Biomove 3000 are similar . to those of the predicate devices.
. Safety and performance testing.
. Comparative Testing

Therefore, the Biomove 3000 System is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues.

{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 with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the department's role within the United States government. The logo is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2005

Ms. Ahava Stein Regulatory Affairs, Consultant for Curatronic Ltd. Beit Hapa'amon (Box 124) 20 Hata'as St., 44425 Kfar Saba Israel

Re: K042650

Trade/Device Name: Biomove 3000 System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: November 28, 2004 Received: December 6, 2004

Dear Ms. Stein:

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.

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

Page 2 - Ms. Ahava Stein

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,
Mark A. Millhaus

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}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): K042650

Device Name: Biomove 3000 System

Indications for Use:

The Biomove 3000 is indicated for:

1.	Stroke Rehabilitation by Muscle Re-education
2.	Prevention or retardation of disuse atrophy
3.	Increasing local blood circulation
4.	Muscle re-education
5.	Maintaining or increasing range of motion

Prescription Use_V (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)

Mark A. Mellers

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number K042650

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).