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For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES), Interferential and Premodulated (IFS)
Relaxation of Muscle Spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS)
Symptomatic relief or management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain
For FES
Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait
For DC Continuous Mode
Relaxation of muscle spasm
For Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

1. Relief of pain, muscle spasms and joint contractures
2. Relief of pain, muscle spasms and joint contractures that may be associated with:
   a) Adhesive capsulitis
   b) Bursitis with slight calcification
   c) Myositis
   d) Soft tissue injuries
   e) Shortened tendons due to past injuries and scar tissues
3. Relief of sub-chronic and chronic pain and joint contractures resulting from:
   a) Capsular tightness
   b) Capsular scarring

Not Found

I'm sorry, but this document does not contain the information requested about acceptance criteria, device performance, or study details.

The provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer (Chattanooga Group / Encore Medical) for their "Vectra GENiSYS" device.

This document primarily states:

• The FDA's determination of substantial equivalence for the device to legally marketed predicate devices.
• The regulation numbers, names, and product codes for the device.
• A list of intended uses (Indications for Use) for various modalities of the device (VMS, Russian, TENS, FES, DC Continuous Mode, Ultrasound).

It does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study proving the device meets acceptance criteria.
• Information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided text.

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