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These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

SP-910 / SP-920 / SP-620 are 1-channel battery-operated user-friendly muscle stimulation systems specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-910/620 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-920 comprises 4 electrodes, which connects the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.

The provided document is a 510(k) summary for the HIVOX Spopad EMS SP-910, SP-920, and SP-620, which are powered muscle stimulators. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with defined acceptance criteria and performance results in the way a clinical trial might.

Therefore, the information requested about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment (as typically found in AI/ML device evaluations) is not present in this 510(k) summary. These devices are much simpler than AI-powered diagnostic tools and rely on established electrical safety and performance standards for their regulatory clearance.

However, I can extract the relevant comparison information that serves as the basis for the declaration of substantial equivalence, which implicitly acts as the "criteria" for approval in this context.

Here's a summary based on the provided text, aligning with your request where possible, and noting when information is unavailable:

Acceptance Criteria and Device Performance (Implicit from Predicate Comparison)

For a 510(k) submission, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The following table summarizes the comparison made by the manufacturer. The reported device performance is presented in comparison to the predicate, with the conclusion that differences are minor and do not raise new safety or effectiveness concerns.

Detailed information based on your numbered points:

1. A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" are implicitly defined by the characteristics of the predicate device and relevant industry standards. The reported performance of the HIVOX devices is compared against these implicit criteria.

2. Sample sizes used for the test set and the data provenance:

   • Not Applicable. This 510(k) summary does not describe a clinical study or a test set in the conventional sense for evaluating a diagnostic or AI device. The comparison is based on the technical specifications of the device and its predicate, and compliance with performance and safety standards.
   • The document implies that the devices meet IEC electrical safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) which involve specific tests, but the sample sizes for these standard compliance tests are not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. No ground truth in the context of expert review for medical imaging or AI performance is mentioned. This device is a muscle stimulator, not an AI diagnostic tool.

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

   • Not Applicable. No such adjudication method is mentioned or relevant for this type of device submission.

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 device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

   • Not Applicable. This is not an algorithm-only or AI device. The "standalone" performance refers to the device's electrical output characteristics and its compliance with safety standards, which are evaluated without human intervention in the loop of its function (though a human operates the device).

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

   • Not Applicable. For a powered muscle stimulator, "ground truth" is typically defined by adherence to engineering specifications and electrical safety standards (e.g., measured current, voltage, frequency must be within specified ranges and below safety limits). The document states that the devices (both predicate and subject) "pass medical device electric safety standard, IEC 60601-1 and standard for Nerve and Muscle Stimulator, IEC 60601-2-10 and electromagnetic compatibility standard IEC 60601-1-2." This compliance with standards serves as the "ground truth" for safety and basic performance.

8. The sample size for the training set:

   • Not Applicable. This product is a physical electrical muscle stimulator, not an AI/ML product that undergoes training.

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

   • Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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