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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.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set (Performance Testing): The document states "summative evaluation, the users evaluated the feeling of stimulation positively" and "Performance testing of the Training Suit 3.0 demonstrated acceptable similarity". It also relies heavily on compliance with various IEC standards (bench testing). No specific sample size for a "test set" of patient data (as relevant for AI/ML diagnostic devices) is mentioned. The "test set" here refers to the device and its components undergoing engineering and electrical safety tests.
• Data Provenance: Not applicable in the context of human data. The tests are bench tests and "summative evaluations" of "users" (likely trained operators or healthy volunteers) in a controlled environment as part of the engineering validation.
• Retrospective/Prospective: Not applicable to this type of device submission.

3. 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. This device is a powered muscle stimulator, not a diagnostic AI/ML device that requires expert-established ground truth from medical images or clinical outcomes. The "ground truth" for this device's safety and performance is established through compliance with recognized electrical safety, EMC, usability, and biocompatibility standards, and comparison to existing predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No human interpretation or qualitative assessment of a test set requiring adjudication.

5. 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 is not an AI-assisted diagnostic device. The device itself delivers electrical stimulation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI/ML diagnostic algorithm. The device's "performance" is its ability to safely and effectively deliver electrical stimulation according to its specifications, which is validated through bench testing and compliance with standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Implicit. For this type of device, the "ground truth" for demonstrating safety and efficacy is established by:
  • Regulatory Standards: Compliance with international consensus standards like IEC 60601 series, ISO 14971, ISO 10993, etc.
  • Predicate Device Performance: Demonstrating that the new device's technical characteristics and performance are substantially equivalent to a previously cleared device.
  • Bench Testing: Engineering measurements conducted to verify specifications and safety.
  • Usability Testing: Verification of safe and effective user interaction (mentioned as "usability performance testing" and "summative evaluation" where users "evaluated the feeling of stimulation positively").

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of AI/ML model development. Its development is based on engineering design, comparison to known safe and effective technologies, and adherence to established manufacturing and quality systems.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set for an AI/ML model, the concept of "ground truth for the training set" is irrelevant in this submission.

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