(238 days)
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:
| Feature/Criterion (Generally Implied by Standards Compliance & Comparison) | Acceptance Criteria (Implied by Standards/Predicate) | Reported Device Performance (as stated in document) |
|---|---|---|
| Electrical Safety | Compliance with AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-2-10:2016 (limits for current, voltage, leakage, etc.) | Tested according to and in compliance with recognized standards. Specific values mentioned in comparison tables are within these limits. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 | Tested according to and in compliance with recognized standards. |
| Software Validation | Compliance with IEC 62304 and FDA's Guidance: General Principles of Software Validation; meeting software system requirements. | Firmware verified and validated. Software validation demonstrated firmware met software system requirements. |
| Usability | Meets intended use safely and effectively by specified users in specified environment (human factors and usability requirements). | Overall system validated. Usability tests successfully conducted following FDA's guidance. |
| Shelf Life of Electrodes | Demonstrated 1-year shelf life and 1-year storage. | Tested according to ASTM F1980-16 with accelerated aging (60°C for 4 weeks). 72 electrodes tested. All tests successfully passed. |
| Current Distribution (Dispersion Testing) of Electrodes | Uniform current distribution. | Bench testing performed according to FDA's requirements. 4 batches of electrodes tested (8 chest, 8 lateral back, 1 upper back, 1 abdomen). Measured prior to and after cleansing, and after accelerated aging. All tests successfully passed. |
| Output Waveforms | Symmetric biphasic, rectangular shape, specific voltage/current ranges (within IEC 60601-2-10 limits). | Oscilloscope tracings obtained under max supported voltage/pulse widths at 500 Ω, 2 kΩ, and 10 kΩ. Values provided in "Output Specifications" table, all stated to comply and be within limits of IEC 60601-2-10. |
| Operational Safety Features | Short-circuit monitoring, watchdog monitoring, no load trip, onload trip, immediate shut-off button, redundant hardware error monitoring, firmware self-tests. | All these features are listed as present in the "miha bodytec II" and the primary predicate. |
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.
§ 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).