(383 days)
The electrical muscle stimulation (EMS) operation mode is indicated for the improvement of abdominal muscle tone, and for the development of a firmer abdomen.
The therapeutic vibrator (Vibration) operation mode is indicated for the promotion of muscle relaxation.
The new device with its proprietary name/model number of Gymform Dual Flex Belt/WB-162 is a single device featured with two modes of operation, independent each other - the electrical muscle stimulation for abdominal muscles conditioning and the therapeutic vibrator for abdominal muscles relaxation.
Upon selected the electrical muscle stimulator (EMS) mode, the flex belt will function as an electrical muscle stimulator capable to achieve toning and firming of muscles in the abdominal region via using transcutaneous electrical muscle stimulation which is a technology for muscle conditioning by sending a stream of electric impulses to the motor nerve of muscle via the pair of single-patient/multiple-application biocompatible cutaneous electrodes on the inner surface of the flex belt, the muscle responds to each electric impulse by producing a contractile twitch, just as it would create voluntary muscle contractions during normal training & strengthening practice, and continues to contract until the electric impulse is over the muscle then returns to its relax state. The level of muscle contraction and relaxation is determined by the electric impulse intensity and the duration applied to the motor nerve of muscle, in which is user selectable via the flex belt control panel.
Upon selected the therapeutic vibrator (Vibration) mode, the Gymform Dual Flex Belt (new device) will function as a therapeutic vibrator to perform muscles relaxation. The therapeutic vibrator (Vibration) mode employs the method of electric muscle massage that simulates natural massage movement of a massage therapist, using oscillating movement of the eccentric motor that installed in the instrument casing to produce linear pulling vibrations to relaxing the abdominal muscle region of a patient.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Gymform Dual Flex Belt. It compares the device to a predicate device, the Slendertone FLEX Abdominal Training System Type 515 (K030708), to establish substantial equivalence.
Based on the document, here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The primary "performance" is compliance with safety standards and showing "same effectiveness" as the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Compliance with recognized consensus safety standards | The device successfully passed testing for conformity with: |
- IEC 60601-1 (General Requirements for Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- IEC 60601-2-10 (Particular requirements for the safety of nerve and muscle stimulators)
- ISO 10993-5 (In Vitro cytotoxicity)
- ISO 10993-10 (Tests for irritation and delayed-type hypersensitivity)
- Complies with FDA safety requirements and IEC 60601-2-10 |
| Effectiveness: Similar to predicate device | "effectiveness test report of Gymform Dual Flex Belt demonstrates that the new device has same effectiveness of predicate device." (Specific metrics for effectiveness are not detailed in this summary.) |
| Technological Characteristics: Similar to predicate device | The EMS mode is "designed, developed and built on the identical technology of electrical muscle stimulation." While specific output parameters differ (e.g., frequency ranges, max intensity levels), the overall mode of action is identical. The document states "verification and validation tests demonstrated the Gymform Dual Flex Belt maintains same safety and effectiveness as that of the cleared predicate device." |
| Intended Use/Indications: Identical to predicate device | The EMS mode of the Gymform Dual Flex Belt is indicated for "improvement of abdominal muscle tone, and for the development of a firmer abdomen," which is stated as "essentially identical to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions an "effectiveness test report" but does not provide any details regarding the sample size used, the characteristics of the test participants, or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It only states that the report demonstrates "same effectiveness" as the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information about experts or ground truth establishment for an effectiveness study. The assessment of effectiveness appears to be based on an internal report that concluded similar effectiveness to the predicate device, but the methodology of that assessment is not detailed.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned or implied. The device is a direct-to-consumer electrical muscle stimulator, and comparative effectiveness studies of this nature are generally not required for 510(k) clearance in this context. The comparison is primarily against the performance characteristics of the predicate device for substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable as the device is a physical muscle stimulator, not an algorithm or AI system. Its performance is inherent in its electrical output and mechanical function.
7. The Type of Ground Truth Used
The document does not specify the type of "ground truth" used for effectiveness testing. Given the nature of a muscle stimulator, effectiveness might be assessed through metrics such as muscle contraction force, muscle circumference changes, or perceived muscle tone/firmness, but these details are not provided. The primary ground for clearance is "comparison of the electric muscles stimulation (EMS) mode" against a predicate.
8. The Sample Size for the Training Set
This question is not applicable as the Gymform Dual Flex Belt is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as 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).