FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The RehaMove is a portable Functional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of:
(1) a motorized movement exerciser (MOTOTMed viva II) produced by Reckcompany
(2) for alternative training of upper extremities a motorized arm crank with same characteristics can be used
(3) FES stimulation controller RehaStim, that generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. The RehaStim can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.
(4) an information cable (RS232) connects the RehaStim and the movement exerciser
(5) 4 electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connected the RehaStim with the electrodes on the skin
(6) an USB interface to connect the RehaStim to PC
(7) The stand-alone mode of RehaStim allows training without movement exerciser.
The system RehaMove allows training for person with impaired functions of lower and upper extremities in two modes:
(1) active mode, using FES support for muscle contractions and if necessary motor power of movement exerciser
(2) passive mode only movement by motorized movement exerciser

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Analysis of K073237 for RehaStim and RehaMove

Acceptance Criteria and Device Performance:

The provided document does not explicitly present a table of numerical acceptance criteria (e.g., target accuracy, precision, or other specific performance metrics) for the RehaStim and RehaMove devices. Instead, the "acceptance criteria" are implied through the concept of substantial equivalence to a predicate device, the "RT300-S"; "RT300-SP" (K060032).

The core of the study presented here is a comparison with a predicate device to demonstrate that the new device is "as safe and effective" as the legally marketed predicate. Therefore, the "reported device performance" is framed in terms of its technological characteristics and intended use being similar to the predicate, and that any differences do not raise new questions of safety or effectiveness.

Implied Acceptance Criteria and Reported Performance (based on substantial equivalence):

Acceptance Criteria (Implied)	Reported Device Performance (RehaStim/RehaMove)
1. Same Intended Use	Both RehaStim and RehaMove are intended for general rehabilitation for: 1. Relaxation of muscle spasms, 2. Prevention or retardation of disuse atrophy, 3. Increasing local blood circulation, 4. Maintaining or increasing range of motion. (Explicitly stated to be the same as the predicate device's intended use).
2. Similar Technological Characteristics (no new safety/effectiveness questions)	Power Source: Mains / Battery Power (Predicate: Mains Power) - Difference, but deemed not to raise new questions.
Controller: Uses custom controller running custom software (Predicate: Based on Pocket PC running custom software) - Difference, but deemed not to raise new questions.
Stimulator (energy delivered): 0-126mA charge balanced stimulator with rectangular impulses (Predicate: 0-140mA charge balanced stimulator with rectangular impulses) - Similar range, deemed not to raise new questions.
Patient Part Type: BF (Predicate: BF) - Same.
Movement Exerciser: Uses motor to create flywheel effect with reduced weight and space (Predicate: Uses motor to create flywheel effect with reduced weight and space) - Same concept.
Arm Crank: Arm crank in the same possible like upper extremities (Predicate: Arm crank in the same possible like upper extremities) - Same concept.
Seating: Allows user to remain in their own seating, e.g. wheelchair eliminating the need for transfer (Predicate: Allows user to remain in their own seating, e.g. wheelchair eliminating the need for transfer) - Same.
Passive Cycling: Utilizes motor to provide assistance during passive cycling (Predicate: Utilizes motor to provide assistance during passive cycling) - Same.
Database Interface: Utilizes database interface for storage and retrieval of patient therapy settings and storage of session logs (Predicate: Utilizes database interface for storage and retrieval of patient therapy settings and storage of session logs) - Same.
3. Equivalent Output Characteristics	The submission states: "Both the RehaMove and RehaStim have the same intended use and the same output characteristics as the predicate device." Output characteristic measurement of the new device was conducted and technically compared with the predicate device.
4. Safety and Effectiveness Equivalent	- The safety and effectiveness of using the movement exerciser has been demonstrated by ongoing clinical use (without stimulation component) in the EU and USA.

The safety and effectiveness of the controller has been demonstrated over its development and many clinical applications.
The remote database enhances safety and effectiveness by ensuring correct therapy settings.
HASOMED's clinical and non-clinical testing have demonstrated that the RehaStim and RehaMove are as safe and effective as the predicate device. |

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a separate "test set" in the context of a clinical trial with a defined number of subjects. The performance data primarily relies on a technical comparison with the predicate device and ongoing clinical use of components (the movement exerciser without FES).
- Data provenance: The document mentions "ongoing clinical use of the movement exerciser without the stimulation component both in the European Union and the U.S.A." This suggests historical data or real-world evidence from these regions. The "development period of the RehaStim and RehaMove and many clinical applications" for the controller also points to potentially internally generated data or general experience rather than a formal, distinct "test set" for this specific 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The submission focuses on technical specifications, equivalence to a predicate, and pre-existing evidence of component safety/effectiveness, rather than a de novo clinical study requiring expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and therefore not provided, as the study described is not a clinical trial or image review requiring an adjudication process for a test set.
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, an MRMC comparative effectiveness study was not conducted and is not applicable. This device is a functional electrical stimulator and movement exerciser, not an AI-powered diagnostic tool that human readers would interpret.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The term "standalone" in this context is ambiguous. If it refers to the performance of the RehaStim stimulator without the movement exerciser, the document states: "The stand-alone mode of RehaStim allows training without movement exerciser." This implies that its functionality as a stimulator was considered independently.
- However, if "standalone" refers to an algorithm's performance without human interaction, that is not applicable as this is a medical device for therapeutic use, not an AI algorithm for interpretation or decision support.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is heavily based on demonstrating equivalence to the predicate device and leveraging the established safety and effectiveness of the predicate and component technologies (e.g., the movement exerciser component's prior clinical use, and the controller's development history).
- There is no mention of explicit "ground truth" derived from expert consensus, pathology, or specific outcomes data collected for a novel clinical trial in this submission to establish the device's efficacy against a gold standard. Instead, the argument is that its performance and safety are comparable to a device already deemed safe and effective.
The sample size for the training set:
- This information is not provided and is not applicable to the type of submission described. This is not an AI/machine learning device that involves a "training set." The development process mentioned for the controller ("development period of the RehaStim and RehaMove and many clinical applications") might imply iterative testing and refinement, but not a formal "training set" in the AI sense.
How the ground truth for the training set was established:
- This information is not provided and is not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device.

Summary

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).