The RehaMove 2 is a portable Functional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of: a motorized movement exerciser (MOTO Med viva II) produced by Reck-company and a stimulator unit (RehaStim 2) produced by Hasomed GmbH. For alternative training of upper extremities a motorized arm crank with same characteristics can be used. The stand-alone mode of RehaStim 2 allows training without movement exerciser.

The system RehaMove 2 allows training for person with impaired functions of lower and upper extremities in two modes:
active mode - using FES support for muscle contractions and if necessary motor power of movement exerciser
passive mode - only movement by motorized movement exerciser

The FES – stimulation controller RehaStim 2 generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. A connection cable enables the RehaStim to receive angle-parameters and to control the Reck Viva II movement exerciser. Two electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connect the RehaStim 2 with the electrodes on the skin. A USB interface gives the possibility to connect the RehaStim 2 to the PC e.g. connect to patient database.

The RehaStim 2 can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.

AI/ML Overview

The provided text describes a Special 510(k) submission for the RehaStim 2 / RehaMove 2 devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies or trials to establish acceptance criteria and prove device performance against them.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance studies is not available in this document because it is not part of a Special 510(k) submission like this.

The submission focuses on comparing the new device's technological characteristics and intended use to a predicate device (RehaStim; RehaMove (Version 1), K073237). The acceptance criteria, in this context, relate to demonstrating that the modifications do not raise new questions of safety and effectiveness and that the device is as safe and effective as its predicate.

Here's an attempt to answer the questions based only on the provided text, highlighting what is implicitly or explicitly stated:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance (as demonstrated in the submission)
Same intended use as predicate device	"Both the RehaMove 2 and RehaStim 2 have the same intended use... as the predicate device."
Same output characteristics as predicate device	"Both the RehaMove 2 and RehaStim 2 have... the same output characteristics as the predicate device."
Technological differences do not raise new questions of safety and effectiveness	"The different technological characteristics do not raise new questions of safety and effectiveness." (Supported by comparative table and safety claims)
Safety and effectiveness are comparable to predicate device	"HASOMED's clinical and non- clinical testing have demonstrated that the RehaStim 2 and RehaMove 2 are as safe and effective as the predicate device." (Implies meeting the safety and effectiveness standards of the predicate)
Performance to specification (for new device)	"The RehaMove 2 / RehaStim 2 device was tested and technically compared with the predicate device." and "The system testing was aligned to verify performance to specification."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not explicitly stated for a formal test set with numerical sample size. The submission refers to non-clinical testing and technical comparisons rather than a specific clinical trial with a defined test set.
Data provenance: Not specified, but the submitter (Hasomed GmbH) is from Germany. The document mentions "ongoing clinical use of the movement exerciser without the stimulation component both in the European Union and the U.S.A." as evidence for the movement exerciser's safety and effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable/Not stated. This type of information is typically collected for clinical performance studies, not for a 510(k) submission focused on substantial equivalence based on technological characteristics and intended use.

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

Not applicable/Not stated. See point 3.

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. This device is a Powered Muscle Stimulator, not an AI-assisted diagnostic or imaging system involving human "readers." The submission makes no mention of such a study.

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

Not explicitly applicable in the context of an "algorithm only" study. The device is a physical medical device (stimulator and movement exerciser). Performance testing mentioned is for the device's technical specifications and controls, not a standalone algorithm. The "stand-alone mode of RehaStim 2 allows training without movement exerciser" refers to the stimulator unit functioning independently, but this is not an "algorithm-only" performance study.

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

Implicitly, the "ground truth" for this 510(k) is the established safety and effectiveness profile of the predicate device. The new device's performance is compared against the predicate's known characteristics and acceptable functionality, as well as its own "performance to specification" (which would be internal technical standards). The document also cites "ongoing clinical use" as evidence for safety and effectiveness.

8. The sample size for the training set

Not applicable/Not stated. Training sets are relevant for machine learning algorithms or AI, which is not the primary focus or a described component of this device in the context of this submission.

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

Not applicable/Not stated. See point 8.

Summary

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

K112844

OCT 2 7 2011

Special 510(k) RehaStim 2 / RehaMove 2

05 510(k) summary

21CFR807.92 / special 510(k)

Name of the legally marketed (unmodified) device

. "

Proprietary name:	RehaStim;
	RehaMove (RehaStim with movement exerciser)
510(k):	K073237
Device Class:	class 2 device
Classification:	Neurology

Submitter's / owner's name, address, Telephone number, a contact person, and the date the summary was prepared:

510k Submitter: Hasomed GmbH

Contact person: Matthias Weber

Address:

39114 Magdeburg

+493916209190

Paul-Ecke-Strasse 1

Germany

Phone:

Fax: +493916230113

Prepared on September 26 2011

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

Name of device, including the trade or proprietary name if applicable, the common or usual name, and the classification name :

"RehaStim 2" of HASOMED GmbH Proprietary name:

"RehaMove 2" (movement exerciser with arm crank, includes RehaStim) of HASOMED GmbH

Common Name:	Powered Muscle Stimulator
Classification Name:	Powered Muscle Stimulator

ldentification of the legally marketed device to which the submitter claims equivalence:

Manufacturer:	HASOMED GmbH
Product:	"RehaStim" ; "RehaMove" (Version 1)
K-number:	K073237
Class:	class 2 device
Product Code:	GZI

A description of the device that is the subject of the premarket notification submission:

The RehaMove 2 is a portable Eunctional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of: a motorized movement exerciser (MOTO Med viva II) produced by Reck-company and a stimulator unit (RehaStim 2) produced by Hasomed GmbH. For alternative training of upper extremities a motorized arm crank with same characteristics can be used. The stand-alone mode of RehaStim 2 allows training without movement exerciser.

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

The system RehaMove 2 allows training for person with impaired functions of lower and upper extremities in two modes:

active mode - using FES support for muscle contractions and if necessary motor power of movement exerciser

passive mode - only movement by motorized movement exerciser

The RehaStim 2 can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.

Statement of the intended use of the device:

Both the RehaStim 2 and RehaMove 2 are intended for general rehabilitation for:

1. Relaxation of muscle spasms
1. Prevention or retardation of disuse atrophy
Increasing local blood circulation 3.
1. Maintaining or increasing range of motion

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

Technological Characteristics

The functions of the RehaMove 2 and RehaStim 2 are the predicate device however there are certain technological similarities and differences as described below:

Technology	RehaStim 2 /RehaMove 2	RehaStim/RehaMove
Power Source	AC and/or storage battery:Power supply: cincon tr30maccording to EN60601-1	AC and/or storage battery:Power supply :mascot typ9920according to EN60601-1
	Battery: BMZ18650 V, Li-IonMangan cells, 2S1P, C= 1600mAh,	Battery: SANYO, NiMh,C= 2700 mAh
Controller	Uses custom processor,running LinuxOS ,runningcustom software	Uses custom controllerrunning custom software
Stimulator (energy delivered)	0-130mA charge balancedstimulator with rectangularimpulses	0-130mA charge balancedstimulator with rectangularimpulses
patient part	Type: BF	Type: BF
movement exerciser	RehaMove 2: Uses motor tocreate flywheel effect withreduced weight and space	RehaMove: Uses motor tocreate flywheel effect withreduced weight and space
Arm crank	Arm crank gives same upperextremities trainingpossibilities as with lowerextremities	Arm crank gives same upperextremities trainingpossibilities as with lowerextremities
	Uses motor to create flywheeleffect with reduced weightand space	Uses motor to create flywheeleffect with reduced weightand space
Seating	Allows user to remain in theirown seating, e.g. wheelchaireliminating the need fortransfer	Allows user to remain in theirown seating, e.g. wheelchaireliminating the need fortransfer
Passive cycling	RehaMove 2: Utilizes motor toprovide assistance duringpassive cycling	RehaMove: Utilizes motor toprovide assistance duringpassive cycling
Database interface	Utilizes database interface forstorage and retrieval of patienttherapy settings and storage ofsession logs	Utilizes database interface forstorage and retrieval ofpatient therapy settings andstorage of session logs

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

Table 5-1 Technological similarities and differences

Determination of substantial equivalence

Test or procedure	Task
Review of user documentation forpredicate device	It was reviewed that equivalent function-nality was implemented in RehaMove 2.
Review of 510(K) submissions forpredicate device	Confirm technical specifications forcompletion of predicate details incomparison tables
Output characteristic measurement of newdevice	The RehaMove 2 / RehaStim 2 device wastested and technically compared with thepredicate device.
Control of system testing	The system testing was aligned to verifyperformance to specification.

Table 5-2 Performance data

It can be matched that there is a substantial equivalence in all important technical and medical characteristics to the premarket notification.

HASOMED concludes that:

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

Both the RehaMove 2 and RehaStim 2 have the same intended use and the same output characteristics as the predicate device. The different technological characteristics do not raise new questions of safety and effectiveness.

The safety and effectiveness of using a movement exerciser to simulate the predicate devices motor powered flywheel and provide passive cycling assistance has been extensively demonstrated in particular by the ongoing clinical use of the movement exerciser without the stimulation component both in the European Union and the U.S.A.

The safety and effectiveness of the controller has been demonstrated over the development period of the RehaStim 2 and RehaMove 2 and many clinical applications.

The remote database enhances the safety and effectiveness of the system by ensuring that patients always starts a therapy session with their latest, accurate device settings.

In conclusion, HASOMED's clinical and non- clinical testing have demonstrated that the RehaStim 2 and RehaMove 2 are as safe and effective as the predicate device.

Product code:

Common Name:

Powered Muscle Stimulator

GZI

{6}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

OCT 2 7 2011

Hasomed GMBH % Mr Matthias Weber HASOMED GmbH Paul-Ecke-Strasse 1 39114 Magdeburg Germany

Re: K112844

Trade/Device Name: RehaMove 2 & RehaStim 2 Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: September 27, 2011 Received: September 29, 2011

Dear Mr. Weber:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-

{7}------------------------------------------------

related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Elinor R. Fehim

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

04 Indications for Use

K112844 510k number if known:

Device Name:

RehaMove 2

RehaStim 2 (stand alone)

Indications for Use:

Both the RehaMove 2 and RehaStim 2 are intended for general rehabilitation for:

1. Relaxation of muscle spasms
1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. Maintaining or increasing range of motion

Prescription Use _ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number K112844

Regulation Number and Section

§ 882.5810 External functional neuromuscular stimulator.

(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).