(280 days)
The XBODY Go USA and XBODY Pro USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
The XBODY Go USA and XBODY Pro USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY Go USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
The XBODY Go USA and XBODY Pro USA 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 respond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, 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 XBODY Go USA and XBODY Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA may therefore be considered a technique of muscle training.
The XBody Go USA and the XBody Pro USA generate electronic muscle stimulation based on EMS technology. The devices are designed as additions to other sports and for training muscles. They are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. They are intended for use only by persons with healthy muscles, not for rehabilitation purposes.
The provided text is a 510(k) Premarket Notification for the XBody Go USA and XBody Pro USA, which are powered muscle stimulators. While it thoroughly compares the new devices to predicates and lists many standards and tests, it does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for an AI/ML medical device.
The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (XBody Newave USA and WiemsPro) through a comparison of various characteristics (technological, performance, safety standards, materials). For a device like a powered muscle stimulator, the "acceptance criteria" are generally tied to meeting recognized safety and performance standards (bench testing) and demonstrating similar intended use and technological characteristics to a legally marketed predicate, rather than a clinical effectiveness study with a specific metric like accuracy, sensitivity, or specificity for a diagnostic AI.
Therefore, many of the specific points requested regarding AI/ML device performance studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable or are not explicitly stated in this 510(k) document because the approval pathway relies on substantial equivalence to existing devices rather than a de novo clinical performance validation against a defined ground truth.
However, I can extract the relevant "acceptance criteria" which, in this context, are the various technical and safety parameters that need to be "similar" or "meet" established standards, and how these performances are demonstrated.
Here is the information that can be extracted or reasonably inferred from the provided text, addressing the prompt's points where applicable, and noting when the requested information is not present or not relevant to this type of device submission:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" in this context are the characteristics and performance parameters that are compared to the predicate devices to demonstrate substantial equivalence. The "reported device performance" is essentially the description of the subject device's characteristics and how they compare to the predicates.
| Acceptance Criteria (Parameter) | Predicate Performance (XBody Newave USA, WiemsPro) | Reported Device Performance (XBody Go USA, XBody Pro USA) | Assessment / Conclusion of Substantial Equivalence |
|---|---|---|---|
| Intended Use | To stimulate healthy muscles to improve or facilitate muscle performance; not for rehabilitation or medical conditions. | Same. Designed as an addition to other sports and for training muscles; for healthy muscles/clients only. | Same. |
| Powered Muscle Stimulator | Yes | Yes | Same. |
| Regulated Voltage | Yes | Yes | Same. |
| Portability/Mobile Use | Portable (17 lbs.), not a mobile device; indoors, requires trained operator. | Portable with ease; not a mobile device; intended environment is indoors; requires qualified and trained operator. | Similar. Both are portable, not mobile. |
| User Interface | Device with touchscreen for control; large START/STOP buttons; clear stimulation controls and parameters; channel identification with pictures; STOP button always visible. | The device can be controlled using graphical windows on the touchscreen of an external control unit (Microsoft Surface Go 2 / Surface Pro 7+). Similar controls and visible STOP button. | Similar. Both utilize a touchscreen control unit. Supports usability performance testing. |
| Operator Requirements | Trainer must complete an XBody US EMS Trainer Course; certification data required for registration. | Trainer must complete an XBody US EMS Trainer Course; certification data required for registration; only registered trainers can use. | Same. |
| Display | 10.4" resistive touchscreen | GO: |
§ 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).