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The E-Fit Infinity System is designated to prescription use (Rx) only.

E-Fit Infinity system (EF-2090 and EF-100) is a machine system with electronic muscle stimulation based on EMS technology. Regarding its use, the output power is limited and specifically designed as an addition to other sports and for toning muscles. It may only be used for healthy muscles and clients, and not to be used for rehabilitation purposes.

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

The E-Fit Infinity system's electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones 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 E-Fit Infinity system can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit Infinity system may therefore be considered a technique of muscle training.

E-Fit Infinity System (EF-2090 and EF-100) is a machine system with electronic muscle stimulation based on EMS technology. Regarding its use, the output power is limited and specifically designed as an addition to other sports and for toning muscles. It may only be used for healthy muscles and clients, and not to be used for rehabilitation purposes.

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

The E-Fit Infinity system's 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 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 E-Fit Infinity system can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit Infinity system may therefore be considered a technique of muscle training.

The provided text is a 510(k) summary for the E-Fit Infinity System, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for device performance. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies) is not directly available in the provided document.

However, I can extract the following relevant information and address the questions to the best of what's provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial's endpoints and thresholds for success. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (E-FIT EF-1280 EMS MACHINE, K133225) by comparing its technological characteristics and by referencing the predicate's safety record and published literature.

The table below summarizes the technical characteristics comparison, which serves as the basis for proving "performance" through equivalence. The "Result" column effectively indicates whether the new device meets the "acceptance criterion" of being similar to the predicate.

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

The document does not describe a traditional "test set" from a clinical study for the E-Fit Infinity System. Instead, it relies on the safety record of the predicate device and the new device.

• Predicate Device Safety Data: "no adverse events have ever been reported since 2010 after over 6 million trainings on devices all over the world manufactured by Fit-Pro Ltd, using a platform equivalent to the predicate device, without a prescription."
  • Sample Size: "over 6 million trainings"
  • Data Provenance: Worldwide, retrospective (data collected since 2010).
• New Device (E-Fit Infinity System) Safety Data: "Over 60,000 trainings - from the 6 million - took place by using E-Fit Infinity System worldwide."
  • Sample Size: "Over 60,000 trainings"
  • Data Provenance: Worldwide, retrospective.

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)

This information is not provided as the submission relies on equivalence and existing safety records, not a specific clinical study involving experts establishing ground truth for a test set.

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

This information is not provided as the submission does not detail a clinical study with an adjudication process for a test set.

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

This is not applicable. The device is an electronic muscle stimulator, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted or referenced.

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

This is not applicable. The device is a physical muscle stimulator, not an algorithm. Its performance is evaluated through its technical specifications and safety record.

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

For safety, the ground truth is indirectly based on the absence of adverse events from a large number of past uses (outcomes data in a broad sense).
For effectiveness, the ground truth is established by referencing published articles in peer-reviewed publications that "demonstrate that electrical stimulation does improve muscle performance and condition." This is a form of scientific consensus/literature review acting as the ground truth.

8. The sample size for the training set

This is not applicable. The E-Fit Infinity System is a hardware device, not a machine learning model that requires a training set in that context. The "training" implied here refers to the extensive safety record of the predicate device and the initial use of the new device itself.

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

As per point 8, this is not applicable in the context of a machine learning training set. The safety and effectiveness claims are based on:

• The long-term safety record of the predicate device (over 6 million trainings without adverse events).
• Published peer-reviewed literature supporting the efficacy of electrical muscle stimulation for muscle performance and conditioning.
• The E-Fit Infinity System itself having accumulated over 60,000 trainings without reported adverse events.

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