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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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miha bodytec II (MBT II) is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, 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, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

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 control unit and the i-body® accessories are connected via cables and must be worn on top of optionally available undergarment.

This document is a 510(k) summary for the "miha bodytec II" powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial or algorithm validation study. Therefore, most of the requested information (regarding expert readers, MRMC studies, ground truth, training sets, etc.) is not applicable to this type of regulatory submission.

However, I can extract the information related to the device's technical acceptance criteria and the engineering and bench testing performed to prove it meets those criteria.

Here's a breakdown of what can be inferred and what is not applicable based on the provided text:

Key Takeaway: This document is a regulatory submission for device clearance based on substantial equivalence, not a clinical study demonstrating performance against specific disease detection acceptance criteria. The "acceptance criteria" here relate to engineering performance, safety standards, and functional specifications, not diagnostic accuracy metrics.

Acceptance Criteria and Reported Device Performance (Engineering/Safety)

The "acceptance criteria" in this context are primarily defined by compliance with recognized electrical safety, electromagnetic compatibility, and software validation standards, as well as functional equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details (Applicable to Engineering/Bench Testing)

2. Sample size used for the test set and the data provenance:

• Test Set (Electrodes for Shelf Life/Dispersion):
  • Dispersion Testing: 4 batches of electrodes. From each batch, 8 chest, 8 lateral back, 1 upper back, and 1 abdomen electrode were selected. (Total: 4 x (8+8+1+1) = 4 x 18 = 72 electrodes).
  • Shelf Life Testing: 72 electrodes (from the same batches, implied).
• Data Provenance: The testing was "bench testing" and conducted "in a climate cabinet" (for accelerated aging). The location (country of origin) is not explicitly stated for these specific tests but the manufacturer is based in Germany. The testing is prospective for the purpose of demonstrating compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the human-expert-reader sense. The ground truth for this type of submission is defined by the compliance of the device's technical specifications and performance against recognized international and national standards (e.g., IEC, ISO, ASTM) and FDA guidance documents. These are objective engineering measurements and validations.

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

• Not applicable. This refers to clinical study methodologies for interpreting results (e.g., medical image interpretation). The "test set" here refers to engineering measurements against predefined standards.

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 device. The submission does not involve human-in-the-loop diagnostic performance studies.

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

• Not Applicable. This is not an algorithm-only diagnostic device. Its performance is related to its physical outputs (electrical impulses) and safety features.

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

• For the engineering and safety performance, the "ground truth" is defined by established international and national standards (e.g., IEC 60601 series, ISO 14971, ASTM F1980-16) and FDA guidance documents.
  • For current distribution: FDA's requirements for bench testing.
  • For software: IEC 62304 and FDA guidance for software validation.
  • For electrical safety/EMC: IEC 60601 series.
  • For usability: IEC 62366-1 and FDA guidance.

8. The sample size for the training set:

• Not Applicable. This device does not use an AI model that requires a "training set" in the machine learning sense. The software validation is for the device's operational firmware, not for an adaptive or learning algorithm.

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

• Not Applicable. See point 8.

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miha bodytec II is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for healthy muscles and clients, not be used for rehabilitation purposes.

miha bodytec II is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. miha bodytec II is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the miha bodytec II training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated.

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.

The various types of muscle work that the miha bodytec II can impose on the stimulated muscles are able to improve or facilitate muscle performance. The miha bodytec II may therefore be considered a technique of muscle training.

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 intensity, 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 control unit and the i-body® accessories are connected via cables and must be worn on top of optionally available undergarment.

miha bodytec II must be used in a professional sport setting. The device must be operated by a trainer who has received a full training from the manufacturer. Before the trainer selects the accessories incl. electrodes in the correct size, applies the athlete i.e. by wearing the electrode vest and connects the straps und belt via cable to the vest and to the control unit. The trainer can choose between several training programs on the control unit for impulse familiarization, invigoration 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 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 to the electrodes via cable. miha bodytec II uses bipolar pulses and supplies all channels equally during all programs.

The provided document is a 510(k) Summary for the miha bodytec II device, which is a powered muscle stimulator. It details various aspects of the device and its comparison to a predicate device (E-Fit EF-1280) to demonstrate substantial equivalence for FDA clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

Important Note: This document is a 510(k) Summary for a Powered Muscle Stimulator, not an AI/ML-enabled diagnostic device for medical imaging. Therefore, many of the typical "acceptance criteria" and "study" elements related to AI algorithm performance (like sensitivity, specificity, MRMC studies, expert consensus for ground truth on imaging data, sample sizes for training/test sets, etc.) as you might expect for an AI diagnostic tool, are not applicable here. The acceptance criteria for this device are focused on electrical safety, electromagnetic compatibility, software validation, usability, biocompatibility, and bench testing to demonstrate functional characteristics and shelf life.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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