(135 days)
The AB COMMAND Dual Channel Fitness Belt is intended for use by healthy persons to apply trans-coetancous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes:
- Improvement of muscle tone of the muscles in the abdomen.
The AB COMMAND Dual Channel Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
AB COMMAND Dual Channel Fitness Belt is a two channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrodes for signal connection to skin. The built-in electrodes are located on the inner surface of the belts.
Power is derived from 2 batteries located in a compartment protected by a removable battery cover for the Fitness Belt. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt.
The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level can be adjustable by user.
The AB COMMAND Dual Channel Fitness Belt is a powered muscle stimulator aimed at improving muscle tone, strengthening, and firming abdominal muscles. The information provided outlines the device's technical specifications and intended use but does not include a study proving its clinical effectiveness against specific acceptance criteria. This submission primarily focuses on establishing substantial equivalence to a predicate device (X2ABS Dual Channel Fitness Belt) based on technical characteristics and safety standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific performance acceptance criteria for the AB COMMAND Dual Channel Fitness Belt in terms of clinical efficacy (e.g., a percentage increase in muscle tone, a specific measure of muscle strength improvement). Instead, it focuses on compliance with electrical safety standards and substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Compliance |
|---|---|---|
| Electrical Safety | IEC 60601-1 (general medical electrical equipment safety) | Testing carried out to assure compliance. |
| IEC 60601-2-10 (particular requirements for nerve and muscle stimulators) | Testing carried out to assure compliance. | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (EMC for medical electrical equipment) | Testing carried out to assure compliance. |
| Software | IEC 60601-1-4 (safety requirements for programmable electrical medical systems) | Performance data verified according to FDA Guidance for Pre Market Submissions and for Software Contained in Medical Devices. |
| Waveform Parameters | (Implicit: Waveform parameters should be within acceptable ranges for muscle stimulation) | Waveform test report provided to verify the parameters of the device. |
| Intended Use / Indications for Use | Intended for: improvement of muscle tone, strengthening muscles, development of firmer muscles in the abdomen. Contraindicated for injured/impaired muscles. Not for therapy/medical conditions. | Device's stated Intended Use and Indications for Use align with the predicate device and were accepted by the FDA. |
| Substantial Equivalence to Predicate Device (K102295) | Similar Intended Use, Indications for Use, technological characteristics, features, specifications, materials, operation, and software. | The submission claims "substantial equivalent" to the predicate device. Differences (trademark, dimension, art design, package) "will not raise new issues of safety and effectiveness." FDA confirmed substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical study with a "test set" and "data provenance" in the context of evaluating the device's clinical efficacy for muscle conditioning. The "testing" mentioned refers to compliance with electrical safety and software standards, not a study involving human subjects to measure muscle improvement.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. As no clinical "test set" for efficacy evaluation is described, there's no mention of experts establishing ground truth for such a study.
4. Adjudication Method for the Test Set
Not applicable. No clinical "test set" for efficacy is described, so no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC study is typically used for diagnostic devices involving human readers. This device is a muscle stimulator, and no such study is mentioned or relevant to the information provided.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a physical muscle stimulator, not an algorithm-only device. Performance data mentioned relates to compliance with safety and software standards, not clinical standalone efficacy.
7. Type of Ground Truth Used
The "ground truth" in this context is primarily derived from technical standards compliance (electrical safety, EMC, software) and the assertion of substantial equivalence to a previously cleared predicate device. There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus on muscle improvement in subjects) as part of this submission's performance evaluation.
8. Sample Size for the Training Set
Not applicable. No machine learning algorithm or AI component requiring a "training set" is described for this device's function or in the performance evaluation.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, this question is not relevant.
§ 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).