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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.

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

• Sample Size for Dispersion Testing: 4 batches of electrodes. From each batch, 8 lateral back-electrodes, 1 upper back-electrode, and 1 abdomen-electrode were selected. Specific numbers of measurement points were defined (8 points from each chest/lateral/upper back electrode, 5 points from each abdomen electrode).
• Sample Size for Shelf Life Testing: 10 electrodes and 6 contact points.
• Data Provenance: The nature of these tests (bench testing, climate chamber simulation) indicates they were conducted in a laboratory setting, likely in Germany, given the manufacturer's location. The tests are "retrospective" in the sense that they are conducted on manufactured components to verify design specifications, not on real-world patient data.

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

Not applicable for this type of submission. The tests performed are engineering and electrical measurements, and compliance with standards. Ground truth for device performance in this context is established by the specifications in the standards themselves and the measurable physical outputs and characteristics of the device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic evaluations where interpretative differences between human readers need to be resolved. The tests described are objective physical and electrical measurements.

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-powered diagnostic tool, so an MRMC study is not relevant.

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

The "Performance Testing" section describes validation of the firmware and electrical output characteristics, which can be considered a form of standalone performance evaluation for the device's electrical functions. This involves oscilloscope tracings of output waveforms and other electrical/thermal tests. The term "algorithm only" is not appropriate as this is a hardware device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance tests described:

• Electrical Safety and EMC: Ground truth is defined by the limits and methodologies specified in the cited international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10).
• Software and System Validation: Ground truth is defined by the software system requirements document and the specifications in the "Guidance Document for Powered Muscle Stimulator 510(k)s" and IEC 62304.
• Bench Testing of Electrodes: Ground truth for uniform current distribution (dispersion) and electrical resistance for shelf life is based on the device's design specifications and the FDA's requirements for such tests.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in that context. The "software" refers to firmware for device control, validated through traditional software engineering processes.

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

Not applicable, as there is no "training set" in the machine learning sense.

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