(213 days)
The GYMFORM® ABS-A-ROUND is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS-A-ROUND may be considered a technique or method for muscle training. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The Mini belt accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately.
The ABS-A-ROUND is a three-channel battery operated muscle stimulation system specifically designed to training muscles. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The stimulation of each channel is active atternately for 2 cycles with its set output intensity level and mode program in below default activation sequence: F channel is active for 180 seconds solely, stop for 10 seconds as idle interval; then L channel is active for 180 seconds solely, stop for 10 seconds as idle interval; then R channel is active for 180 seconds solely, stop for 10 seconds as idle interval; repeat one cycle with above activation sequence. The Mini belt accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately. It is comprised of an electronic stimulator module for signal generation, two belts for fixation, and electrodes for signal connection to skin. The electrodes are replaceable. Power is derived from 3 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 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.
Here's an analysis of the provided text regarding the GYMFORM® ABS-A-ROUND device, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions primarily focus on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical studies that would typically define "acceptance criteria" and "device performance" in the way one might expect for a novel device or a high-risk device. The "performance" discussed here largely refers to compliance with electrical safety and EMC standards, and a comparison of technical specifications to predicate devices. There is no mention of a formal clinical performance study in the provided text that would establish typical diagnostic or therapeutic performance metrics like sensitivity, specificity, accuracy, or effect sizes for human improvement.
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary, the "acceptance criteria" are primarily related to safety, electrical performance, and substantial equivalence to predicate devices, rather than clinical efficacy. The reported "performance" aligns with these compliance aspects.
| Acceptance Criterion (Implied/Explicit) | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with IEC 60601-1 and IEC 60601-2-10 standards. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard. |
| Waveform Parameters | Waveform test report provided to verify device parameters. |
| Biocompatibility | All user-contacting materials comply with ISO10993-5 and ISO10993-10. |
| Substantial Equivalence | Considered substantially equivalent to predicate devices; differences do not raise new safety or effectiveness issues. |
| Intended Use | Stimulate healthy muscles to improve/facilitate muscle performance; considered a technique/method for muscle training. |
| Functional Specifications | Different from predicate devices in channels, programs, phase variations, output, frequency range, pulse width, power, operating/storage environment, electrode size, and maximum current density, but all comply with relevant IEC standards and FDA guidance, thus not raising safety/effectiveness issues. |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No specific test set or clinical study data is mentioned for evaluating muscle performance or clinical outcomes. The "testing" mentioned refers to compliance with electrical safety and EMC standards. These are typically bench tests or simulations, not human subject studies.
- The manufacturer is Well Brain International Ltd., located in Hong Kong SAR, China.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no mention of a study requiring expert-established ground truth for a test set in the context of clinical performance. The documentation focuses on engineering and regulatory compliance.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication method is described.
-
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 imaging analysis or diagnostic AI device. There is no mention of an MRMC study or AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a direct-use muscle stimulator, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. The "truth" or reference used in this submission relates to established electrical safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and biocompatibility standards (ISO10993-5, ISO10993-10), as well as FDA guidance for EMS devices. These are engineering and regulatory benchmarks, not clinical ground truth.
-
The sample size for the training set
- Not applicable. This device does not use machine learning or require a training set in the conventional sense.
-
How the ground truth for the training set was established
- Not applicable. As above, no training set or associated ground truth establishment process is mentioned.
Summary of the 510(k) Submission's Approach:
The Well Brain International Ltd. 510(k) submission for the GYMFORM® ABS-A-ROUND is a typical example of demonstrating substantial equivalence for a Class II medical device. The "acceptance criteria" are primarily regulatory and engineering compliance requirements. The "study" mentioned consists of testing the device against recognized electrical safety, EMC, and biocompatibility standards, and then demonstrating that its technical specifications and intended use are similar enough to existing, legally marketed predicate devices such that any differences do not raise new concerns about safety or effectiveness. There is no clinical performance study data presented in this summary to establish efficacy or diagnostic accuracy, which is common for devices of this type seeking a 510(k) clearance based on substantial equivalence.
§ 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).