(77 days)
Interferential Stimulation can be used in the following applications:
- · Symptomatic relief of post-surgical and/or post traumatic acute pain
- · Symptomatic relief of chronic intractable pain
- Relaxation of muscle spasms
- Maintain or increase range of motion
- Increase local blood circulation
Neuromuscular Stimulation can be used in the following applications:
- · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
- · Prevention or retardation of disuse atrophy
- · Muscle-re-education
The Avid CT2, Model AV-CT20A is a combination therapy device. Like its predicate Avid IF2, it is an Interferential Stimulator that produces a low electrical current that is transmitted via lead wires to electrodes placed on the skin in the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and a keypad. The primary difference between the two devices is the addition of user- adjustable parameters that allow the existing interferential waveform to turn on and off within a small, preselected range to provide necessary control for neuromuscular stimulation. This same method of gating the interferential on and off was used in VQ's previous Surgi Stim stimulator.
The provided text is a 510(k) summary for a medical device called the "Avid CT2 Neuromuscular and Interferential Stimulation System." It aims to demonstrate substantial equivalence to previously cleared predicate devices.
However, the document does not contain the information requested in the prompt regarding acceptance criteria for device performance studies, sample sizes, expert involvement, or MRMC studies. This type of information is typically found in clinical study reports or validation documents, not in a 510(k) summary focused on demonstrating equivalence through comparison to predicate devices' specifications and functionalities.
The document primarily focuses on bench testing and electrical output comparisons to establish substantial equivalence, rather than human-in-the-loop performance studies or clinical effectiveness trials that would involve the detailed data collection and analysis described in the prompt.
Therefore, I cannot extract the requested information from this document. The prompt's requirements pertain to performance studies, especially those involving human interaction or clinical outcomes, which are not detailed in this 510(k) summary.
§ 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).