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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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WIEMSPRO is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSPRO is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, 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.

WIEMSPRO electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to 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 device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances.

WIEMSPRO is a device with electronic muscle stimulation based on EMS technology. Reqarding its use, 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 rehabilitationpurposes.

This document is an FDA 510(k) summary for a powered muscle stimulator called "WIEMSPRO." It's a regulatory submission, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance results from a study, sample sizes, expert ground truth establishment, or clinical study details.

The document explicitly states:

• "No clinical studies provided."
• "We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE):"
  • "0. General information of both devices is the same"
  • "1. Intended use and indications/principle of operations of both devices are the same."
  • "2. There are no differences in the technological characteristic/performance data of the proposed device and those of the predicate device. Thus, the SE is not affected."
• The comparison table (pages 4-5) lists technical specifications and notes "Same" for almost all characteristics between the original WIEMSPRO (K181955) and the "Modified Device" WIEMSPRO (K211298), except for the software version which is "Similar."

This 510(k) submission relies on demonstrating substantial equivalence to a previously cleared predicate device (K181955) by showing that the new device has the same intended use, indications for use, and similar technological characteristics, and that any minor differences do not raise new questions of safety or effectiveness. It does not present new performance data from a specific study designed to meet acceptance criteria through statistical testing.

Therefore, it's not possible to fill out the requested table or answer the questions based on the provided text, as this type of information is typically found in a clinical study report or a different section of a more comprehensive 510(k) submission if new performance data were required.

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