(267 days)
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
| Acceptance Criteria Category | Specific Criteria/Tests Conducted | Reported Device Performance (Compliance/Results) |
|---|---|---|
| Electrical Safety | Compliance with AAMI ANSI ES 60601-1_2005/(R)2012 And A1:2012 | In compliance. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 | In compliance. |
| Software/Firmware Validation | Compliance with IEC 62304:2015 and FDA's "General Principles of Software Validation" | Verified and validated; firmware met software system requirements. |
| System Validation (Functional) | Oscilloscope tracings of output waveforms under various loads (500 Ω, 2 kΩ, 10 kΩ) with maximum supported voltage and pulse widths. | Tracings obtained (results not explicitly detailed but implied compliance with expected output). |
| System Validation (Functional, Other) | Electrical tests of interfaces, thermographic inspections, climate chamber tests, shock and vibration tests. | Conducted (results not explicitly detailed but implied compliance). |
| Usability Validation | Compliance with IEC 62366-1:2015 and FDA's guidance on usability. Confirmation that device meets intended use safely and effectively by specified users in specified environment, considering human factors. | Overall system validated; UI tested for usability according to FDA's guidance. |
| Biocompatibility | Skin contacting material tested to ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2009 (irritation/sensitization). | Tested to these standards (results implied acceptable). |
| Shelf Life | Accelerated aging simulation (60°C for 4 weeks) with typical training current applied to electrodes; tested for 1-year shelf life and 1-year storage. | All tests successfully passed. |
| Dispersion Testing (Electrodes) | Uniform current distributions bench testing using 4 batches of electrodes (8 chest, 8 lateral back, 1 upper back, 1 abdomen electrode from each batch). Measurements taken prior to and after cleansing, and after accelerated aging. | All tests successfully passed. |
| Output Specifications (Comparison to Predicate) | Max Output Voltage: miha bodytec II: |
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).