(28 days)
Both the RehaMove 2 and RehaStim 2 are intended for general rehabilitation for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Maintaining or increasing range of motion
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.
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.
§ 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).