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The Neuro20 PRO System is intended to stimulate muscles in order to improve or facilitate muscle performance.

Other indications for use include:

• · Re-educating muscles
• · Increasing local blood circulation
• · Maintaining or increasing range of motion
• · Relaxation of muscle spasm
• · Retarding or preventing disuse atrophy

The Neuro20 PRO System is a powered muscle stimulator designed for individual or group rehabilitation and recovery. The Neuro20 PRO System is a transcutaneous electrical muscle stimulation (EMS) device which stimulates motor nerves by means of electrical impulses transmitted by electrodes. The system utilizes electrical stimulation to create an involuntary contractions of motor neurons are transmitted to the muscle fibers where they stimulate a muscular response.

Depending on the parameters of the electrical impulses (pulse intensity, pulse duration, pulse width, pulse rise, pause time, total session duration), different types of muscle work can be imposed on the stimulated muscles. The involuntary muscle activation can be voluntarily over-ridden through intentional exercise. Individual intensity levels can be modulated for each muscle group. One to ten patients may be treated within a session.

The Neuro20 PRO System is comprised of three major components: the Control Box with battery (the muscle stimulator), Smart Suit (the wearable suit with electrodes covering the muscles), and Operating Tablet with software which allows the medical professional to adjust the parameters for the patient. Users may be actively engaged within a variety of training modes while the clinician/operator controls the software. The Neuro20 PRO System accessories are a battery charger, protective case, and Smart Suit packaging.

The Neuro20 Control Box connects to the suit and is powered by a battery. It is controlled by the medical practitioner operating the software. The Smart Suit applies the electrodes to the upper body, arms, legs, and buttocks. The Control Unit is connected to the Operating Tablet wirelessly.

The Neuro20 PRO System is a powered muscle stimulator intended to improve or facilitate muscle performance, re-educate muscles, increase local blood circulation, maintain or increase range of motion, relax muscle spasm, and retard or prevent disuse atrophy.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The device's compliance with the acceptance criteria is demonstrated through a series of non-clinical performance tests evaluating its safety, essential performance, and functionality according to recognized international and national standards.

2. Sample Size for the Test Set and Data Provenance:

The provided document does not specify a "test set" in the context of clinical data for performance evaluation. All performance data is based on non-clinical testing against relevant standards. Therefore, information regarding sample size and data provenance (e.g., country of origin, retrospective/prospective) for a test set of data is not applicable for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as no clinical test set requiring expert-established ground truth was used for this submission. The evaluation was based on non-clinical engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was conducted or referenced in the provided document. The submission explicitly states: "The determination of substantial equivalence using clinical performance data is not applicable because such data is not required to determine the substantial equivalence of the Neuro20 PRO System to the cited predicate devices." Therefore, no effect size of human readers improving with or without AI assistance is provided.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The Neuro20 PRO System is an electrical muscle stimulator, not an AI or algorithm-based diagnostic/therapeutic device that would typically undergo standalone algorithm performance studies. The compliance is demonstrated via adherence to safety and performance standards for muscle stimulators.

7. Type of Ground Truth Used:

The "ground truth" for demonstrating the device meets its acceptance criteria is based on adherence to established international and national performance and safety standards for medical electrical equipment, particularly for nerve and muscle stimulators. This includes standards related to electrical safety, electromagnetic compatibility, software lifecycle processes, risk management, usability engineering, and biological evaluation of medical devices.

8. Sample Size for the Training Set:

Not applicable, as this is related to clinical data for algorithm training, which was not part of this 510(k) submission for a powered muscle stimulator.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set requiring ground truth establishment for an algorithm was used.

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miha bodytec II is a device which performs electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles.

miha bodytec II is intended to stimulate muscles in order to improve or facilitate muscle performance. In addition it is indicated for the following conditions:

• Re-educating muscles
• Relaxation of muscle spasm
• Retarding or preventing disuse muscle atrophy

The miha bodytec II electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

miha bodytec II may only be used by persons above the age of 21.

miha bodytec II is a transcutaneous electrical muscle stimulation (EMS) device which stimulates motor nerves by means of electrical impulses transmitted by electrodes. These excitations of motor nerves are transmitted to the muscle fibers where they stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, pulse duration, pulse width, pulse rise, pause time, total session duration), different types of muscle work can be imposed on the stimulated muscles.

miha Bodytec II consists of a control unit mounted on a stand for the selection of programs, setting the parameters and starting/stopping the device, the i-body® electrode vest for applying electrodes to the upper body, i-body® straps for applying electrodes to the arm and legs and the i-body® belt for applying electrodes to the buttocks.

The device encompasses the following variants:

• "Miha bodytec II" control unit connected to the electrodes via cable
• "Miha bodytec II" control unit connected via Bluetooth through the "i-body connect wireless" device"
• "Miha bodytec m.ove" control unit for mobile use connected via Bluetooth through the "i-body connect wireless" device"

The "miha bodytec m.ove" is a lighter version of the "miha bodytec II" device. Almost all electrical components and circuit boards are identical. It shall mainly be used as a mobile solution either with "travel station m.ove" or with "work station m.ove" in medical facilities. It must be connected with the electrode system via the additional wireless stimulation equipment "i-body connect wireless" and has no cable connection.

The "travel station m.ove" is an equipment for the "miha bodytec m.ove" device (not for miha bodytec II) and is supposed to be used as a mobile solution for personal trainers all around the world. It will be used as a "bag" or "suitcase" where the device and the electrodes can be safely stored while travelling and will be used as a stand while the training with the customer is in progress. It has no electronics built in and is mainly made out of textiles, plastics and aluminum.

The "work station m.ove" is an additional equipment for the "miha bodytec m.ove" (not for miha bodytec II) and is supposed to be mainly used in hospitals, physiotherapy facilities and homes for the elderly. It will be used as a transport solution where the device and the electrodes can be safely stored while moving through the facilities and will be used as a stand while the training with the patient is in progress. It has no electronics built in and is mainly made out of wood, plastics and aluminum/steel.

The "i-body connect wireless" is a portable device, which is supposed to be worn at the patient's body. It has a built in stimulation circuit board and a Bluetooth receiver and produces the stimulation itself while the main device only acts as a remote control. This way a wireless training / treatment of the trainee / patient is possible. On the one hand, it is a mandatory equipment for the "miha bodytec m.ove" device due to the missing cable connection. On the other hand, it is an additional equipment for the "miha bodytec II" device, which can be used instead of the main connection cable. Through a corresponding software update, the second generation of the device (primary predicate device, K201975) can be changed into a third generation version (subject device, K221498), enabling the wireless functions of the device and thus compatibility with the i-body connect wireless.

miha bodytec II must be used in a professional setting incl. professional sport setting and stationary in closed rooms (clinics, hospitals, nursing homes, doctor's offices, physical therapists' private offices). The device must be operated by a trainer who has received a full training from the manufacturer. Before the training, the trainer selects the accessories in the correct size, applies the electrodes to the athlete/patient i.e. by wearing the electrode vest and connects the straps and belt via cable to the vest and via the "i-body connect wireless" device to the control unit. The trainer can choose between several training programs on the control unit for impulse familiarization basic/advanced, muscular endurance and body relax. The intensity can be adjusted by the trainer at the UI of the control unit separately for each channel. Complete body training which addresses all muscle groups is possible with up to 10 pairs of electrodes. Each athlete/patient receives an RFID transponder card for storing training results and individually adjusted programs. Once the training is started, the control unit generates and transmits the electrical signals wirelessly to the "i-body connect wireless" device and thus to the electrodes. miha bodytec II uses bipolar pulses and supplies all channels equally during all programs.

During pulse application, the trainer instructs the athlete/patient on specific exercises to perform. The training can be stopped anytime by pressing the multi-function / stop button.

This document is a 510(k) summary for the Miha Bodytec II, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with acceptance criteria in the typical sense of a clinical trial for diagnostic devices. Therefore, much of the requested information regarding sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies (MRMC) would not be found in this type of submission.

The "acceptance criteria" and "reported device performance" provided are primarily related to safety, electrical output specifications, and regulatory compliance, demonstrating that the device functions as intended within established safety limits and industry standards.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is derived from the "Output Specifications" table (Table 2) and the "Performance Testing" section. Due to the nature of a 510(k) for a powered muscle stimulator, the "acceptance criteria" are generally compliance with international safety standards and performance within specified technical ranges, rather than clinical efficacy metrics like sensitivity or specificity.

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