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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.

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.

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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.

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