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1. Relaxation of muscle spasms;
2. Prevention or retardation of disuse atrophy;
3. Increasing local blood circulation;
4. Muscle re-education;
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
6. Maintaining or increasing range of motion.

When the device is used in a manner that delivers continuous, uninterrupted pulses, it is indicated only for the relaxation of muscle spasms. The Variable Stim output mode delivers continuous, uninterrupted pulses. The Auto Stim output mode delivers bursts of pulses that are interrupted with 1 second "off" periods.

The Diamond MediStim is a powered muscle stimulator, which is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The machine uses 2 modes: VARIABLE STIM and AUTO STIM. The device has CE approval.

The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it describes a medical device called the "Diamond MediStim & Diamond CliniStim" and outlines details related to its 510(k) submission to the FDA.

Specifically, the document includes:

• Manufacturer and Contact Information: Diamond International Corp Pty Ltd and Diamond Systems USA Inc.
• Device Name and Classification: Diamond MediStim & Diamond CliniStim, classified as a Powered Muscle Stimulator (Class 2).
• Predicate Device: Ultratone (K926410).
• Description of Device and Intended Use: Details modes of operation (VARIABLE STIM, AUTO STIM) and 6 intended medical uses.
• Non-clinical Test: A comparison of the Diamond MediStim to the Ultratone focusing on controls, waveforms, output levels, and patient leakage current, concluding substantial equivalence.
• FDA Correspondence: A letter from the FDA determining substantial equivalence to the predicate device, allowing marketing, and outlining regulatory responsibilities.
• Indications for Use: A formal list of the 6 intended uses.

There is no mention of specific acceptance criteria, performance metrics, a clinical study with a test set, ground truth determination, reader performance, or training set details. The non-clinical test simply established "substantial equivalence" based on waveform and output characteristics compared to a predicate device, which is not a clinical performance study with acceptance criteria.

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