(248 days)
The XBODY Go USA and XBODY Pro USA are machines with electronic muscle stimulation based on EMS technology. The devices are specifically designed as an addition to other sports and for training muscles. They must be used only for healthy muscles and clients, not for rehabilitation purposes.
Both models are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Neither model is 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 or XBODY Pro USA training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated.
For both models, 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 of contraction, 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. Both models may therefore be considered a technique of muscle training.
The XBody Go USA and the XBody Pro USA generate electronic muscle stimulation based on electrical muscle stimulation (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.
Based on the provided FDA 510(k) Clearance Letter and Submission Summary, here's a description of the acceptance criteria and the study that proves the device meets them:
Important Note: The provided document is a 510(k) submission summary, primarily focused on establishing substantial equivalence to a predicate device. It details the similarities and minor differences between the new device and the predicate. For devices like the XBody Go USA and XBody Pro USA, which are "Powered Muscle Stimulators," the primary "performance" and "acceptance criteria" revolve around demonstrating equivalence in electrical safety, electromagnetic compatibility, and fundamental stimulation characteristics, rather than a clinical study measuring a specific physiological outcome (like muscle strength improvement). The document explicitly states, "Any differences that exist between the subject and predicate devices do not affect safety or performance." This implies that the acceptance criteria are largely met by demonstrating adherence to recognized safety and performance standards and showing that any changes do not negatively impact these.
Therefore, the "proof" described is not a typical clinical trial demonstrating superiority or non-inferiority in effectiveness, but rather a demonstration of continued safety and equivalent performance to a device already deemed safe and effective.
Acceptance Criteria and Device Performance Study
The acceptance criteria for the XBody Go USA and XBody Pro USA, as implied by the 510(k) submission, are primarily centered around demonstrating essential safety and equivalent performance to their predicate devices, particularly regarding electrical muscle stimulation parameters and the introduction of new accessories (the XBody DrySuit and DryWear). Since this is a 510(k) for a powered muscle stimulator, the "performance" proved is not a clinical outcome like muscle strength gain, but rather the device's ability to safely and effectively deliver electrical impulses as intended, consistent with the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) (substantial equivalence for a powered muscle stimulator), the "acceptance criteria" are predominantly related to compliance with recognized standards and maintaining equivalent technical specifications and safety profiles. The "device performance" is therefore demonstrated by meeting these standards and showing that the subject device's operation is not adversely affected by the minor changes.
| Acceptance Criteria (Implied) | Reported Device Performance (as demonstrated) |
|---|---|
| Electrical Safety (IEC 60601-1, 60601-2-10) | Validated through independent testing. Product meets max output voltage, current, phase charge, current density, power density, net charge, waveform shape specifications, and incorporates safety circuits (overload, no-load trip, battery monitoring, watchdog). |
| Electromagnetic Compatibility (IEC 60601-1-2) | Validated through independent testing. Device is compliant. |
| Usability (IEC 60601-1-6, IEC 62366-1) | User interface is described as "large and easily controllable" with clear stimulation parameters and channel identification. Operator training and certification are required. Updated control units maintain ease of use. |
| Software Life Cycle (IEC 62304) | Software differences are minor, aiming to enhance user interface without impacting safety/effectiveness. Compliance with IEC 62304 is stated. |
| Biocompatibility (ISO 10993-1, -5, -10) | Cotton underwear is "biocompatibility certified." New DryWear and DrySuit materials are implied to be compliant through risk management and biocompatibility standards. |
| Maintaining Intended Use & Indications for Use | Devices have "same in indication for use, intended use performance, design, dimensions, and materials as the predicate devices." The new DrySuit is stated to have "acceptable similarity in intended use." |
| Equivalent Output Specifications | Output voltage, current, phase charge, current density, power density, net charge, waveform, burst mode parameters, output frequency, and pulse widths are all "Same" as the predicate. |
| Equivalent Portability/Environment of Use | "Portable with ease," "indoors," "home healthcare environment." Same as predicate. |
| Safe Use of New Accessories (DrySuit/DryWear) | Performance testing of the XBody DrySuit demonstrated "acceptable similarity in intended use." Instructions for use (e.g., wearing undergarments) ensure safe conductivity. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "sample size" in the context of a data-driven test set for complex performance metrics like accuracy or sensitivity/specificity for an AI/ML device. For this type of device, the "test set" is more conceptual, referring to the various configurations and conditions under which the device's electrical safety, EMC, and fundamental performance characteristics were validated through bench testing.
- Sample Size: Not applicable in the typical sense for a clinical data set. The validation is based on engineering tests performed on production units or prototypes.
- Data Provenance: The data comes from "independent testing" of the XBody Actiwear G2 main unit, the control unit, the XBody Training Suit 2.1, the XBody Training Suit 3.0, and the new XBody DrySuit. This implies lab-based testing. The country of origin of the data/testing is not specified, but the manufacturer is XBody Hungary Kft. The testing would be considered prospective in the sense that it's conducted to demonstrate compliance for the submission, rather than retrospective analysis of existing clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. For a powered muscle stimulator's safety and performance testing, "ground truth" is established by calibrated instruments and adherence to engineering standards (e.g., peak voltage, current, waveform shape, and safety circuit functionality). There is no "expert consensus" on an image or clinical finding that requires adjudication.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment of data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML diagnostic or image-based device that would typically undergo an MRMC study to assess human reader improvement with AI assistance. The device's function is direct electrical muscle stimulation, not assisting in interpretation.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical electromedical device, not a standalone algorithm. Its performance is intrinsically linked to its hardware and software working together to deliver electrical impulses.
7. Type of Ground Truth Used
The "ground truth" is based on:
- Engineering specifications and standards: Adherence to output parameters (voltage, current, frequency, pulse width) as defined by electrical engineering principles and the device's design.
- Safety standards: Compliance with IEC 60601 series standards for electrical safety and electromagnetic compatibility.
- Predicate device characteristics: The predicate device itself effectively serves as a "ground truth" or benchmark for acceptable performance and safety, as the submission aims to demonstrate substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that learns from a "training set" of data in the typical sense of machine learning. The device's behavior is deterministic, based on its programmed logic and hardware design.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device. The ground truth for the device's design and functionality is rooted in established electrical engineering principles, medical device safety standards, and the performance characteristics of the legally marketed predicate device.
§ 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).