(15 days)
Muscle Stimulation, Interferential and Non-Interferential 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 .
Pain Relief, Interferential Current Modality
- Relieve acute pain .
- Relieve and manage chronic pain .
The RS2mi device family consists of a hardware/software system that can be setup as one of four devices: an RS2m which is a pulse mode muscle stimulator only, an RS2i which is an interferential stimulator only, an RS2c which can act as either a pulse mode muscle stimulator or an interferential stimulator, or an RS2s which acts as a sequential stimulator by first providing an interferential treatment segment followed by a pulse mode muscle stimulation segment. The software system is setup to emulate one of these four devices and the device faceplate is setup to indicate to the user the features of that device only. To provide flexibility, the faceplates can be interchanged by RS Medical to create the type of device needed in the marketplace. Throughout this document the name RS2mi is used to indicate this 'family' of four separate devices.
The RS2mi device family, 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 RS2mi is housed in a plastic enclosure. The front of the enclosure houses LED patient indicators. The accessories provided with the RS2mi include the output cables, the electrode pads, and the AC Charging Adapter.
The RS2mi pulse mode muscle stimulation modality operates at a specified 57.5 volts peak (+/-10% into a 500 ohm load) and 115 mA peak (+/-10% into a 500 ohm load) with a maximum pulse width of 415 uSec.( +/-10%) and a cycle frequency of 71 Hz(+/-5%). The pulses are bi-phasic. Intensity levels are controlled via pulse width while maintaining the pulse voltage within the specified peak. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.
The RS2mi interferential modality operates at a specified maximum of 100 mA peak (+/-10% into a 500 ohm load). The carrier and interferential signals are simulated sine wave symmetric, balanced 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) Pre-market Notification for the RS2mi Muscle Stimulator family, dated May 15, 2002. It describes a medical device that provides muscle stimulation and interferential current modalities.
However, the provided document does not contain information about acceptance criteria, the study that proves the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment relevant to the request.
The FDA's review letter confirms that the device was found substantially equivalent to a predicate device (RS-4M Plus, K000114), meaning it has the same intended use and similar technological characteristics. The document primarily focuses on the device description, indications for use, and a comparison to its predicate device to establish substantial equivalence. It does not detail specific performance studies with acceptance criteria as typically understood for AI/ML devices or novel medical technologies requiring extensive clinical validation.
The "device performance" described in the document pertains to the technical specifications of its electrical output (e.g., peak voltage, mA, pulse width, frequency) and how they compare to the predicate device. These are engineering specifications, not clinical performance metrics against specific acceptance criteria in a study.
Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria and a study that proves the device meets those criteria, as the information is not present in the provided text.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).