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Muscle Stimulator Modality

• Relax muscle spasms
• Prevent or retard disuse atrophy
• Maintain or increase range of motion
• Increase local blood circulation
• Re-educate muscle
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
  Interferential Current Modality
• Relieve acute pain
• Relieve and manage chronic pain
• Relax muscle spasms
• Maintain or increase range of motion
• Increase local blood circulation

The RS-4V, like a number of legally marketed predicate devices, incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4V is housed in a plastic enclosure. The front of the enclosure houses LCD operator display. The accessories provided with the RS-4 V include the output cables, the electrode pads, and the AC Charging Adapter.
The RS-4V muscle stimulation modality operates at approximately 100 volts peak (no load) and 60 mA peak (1000 ohm load) with a pulse width of 415 uSec.(maximum) and a cycle frequency of 71 Hz. The pulses are bi-phasic. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.
The RS-4V interferential modality operates at approximately 100 mA peak-to-peak on a 500 ohm load. The carrier and interferential signals are true sine wave symmetric outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).

The provided text is a 510(k) summary for the RS-4V Muscle Stimulator. It describes the device, its indications for use, and declares substantial equivalence to predicate devices (RS-4M and Stellar HS-04). However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or clinical study methodologies.

The 510(k) summary is a regulatory filing that demonstrates substantial equivalence to a legally marketed predicate device, rather than providing the detailed results of a performance study. It states that the device is "substantially equivalent" to its predecessors, implying that its performance is implicitly considered acceptable based on the predicate devices.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample sizes for test sets or data provenance
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results or effect size
• Standalone performance information
• Type of ground truth used
• Sample size for training set
• How ground truth for the training set was established

The document focuses on the technical specifications and regulatory aspects (device description, indications for use, and comparison to predicate devices for substantial equivalence) rather than a detailed performance study.

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