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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 EMG: To determination the activation timing of muscles for: a) retraining of muscle activation, b) coordination of muscle activation, An indication of the force produced by muscle for control and maintenance of muscle contractions, Relaxation muscle training, Muscle re-education. For EMG triggered Stim: Stroke rehab by muscle re-education, Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion. 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.

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any criteria. The document is a 510(k) substantial equivalence letter from the FDA for a device called "Vectra GENiSYS (Intelect Legend XT)".

This document primarily:

• Identifies the trade name, regulation numbers, regulation names, regulatory class, and product codes for the device.
• States that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
• Outlines general controls and additional controls that may apply to the device.
• Lists the specific "Indications for Use" for various modalities offered by the device (e.g., VMS, Interferential, Microcurrent, TENS, FES, DC Continuous Mode, EMG, EMG triggered Stim, Ultrasound).

The text does not contain details on:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Any study design (e.g., sample size, data provenance, ground truth establishment).
• Any performance results or data to demonstrate the device meets acceptance criteria.
• Information about expert involvement, adjudication methods, or MRMC studies.

Therefore, I cannot provide a response filling in the requested table and details because the information is not present in the provided document.

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