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relaxation of muscle spasms; prevention or retardation of disuse atrophy; increasing local blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and maintaining or increasing range of motion.

The Unit ELECTROMEDICARIN 900 is a 3-channel electrostimulator of low and medium frequency currents. The 3 output channels makes possible to treat 3 patients at the same time or synchronize several muscle groups. The unit is controlled by a microprocessor which allows a wide variation of parameters in order to work with the optimal currents all the time and for each patient: pulse width, bursts, relaxation time, time of increasing and decreasing ramps, modulation frequency, vector type, ... See all types of waveforms in "Technical Characteristics". Also, the user can save his/her own parameters in non-volatile memory. The unit has a 320x240 pixels monochrome (white and blue) LCD of 9" and the Menu options and intensity are selected by means of endless encoders. The end of the treatment is notified with a melody or a sequence of beeps.

The provided text is a 510(k) summary for the ELECTROMEDICARIN 900 electrostimulator, dated February 10th, 2003. This document focuses on demonstrating substantial equivalence to a predicate device (Rich-Mar Corporation's Winner ST4 Stimulator, K000808), rather than presenting a study with specific acceptance criteria and performance data for the ELECTROMEDICARIN 900 itself.

Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone studies, and training set details) is not applicable or not available in this type of regulatory submission.

The 510(k) process for this device relies on showing that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device. The "study" here is essentially the comparative analysis against the predicate device to demonstrate substantial equivalence, rather than a clinical trial measuring a specific outcome for the ELECTROMEDICARIN 900.

Here's a breakdown of the available and applicable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for substantial equivalence, formal "acceptance criteria" for a specific performance study of the ELECTROMEDICARIN 900 are not defined. Instead, the acceptance criteria are implicitly that the technological characteristics and indications for use are similar enough to the predicate device as deemed by the FDA. The reported "performance" for the ELECTROMEDICARIN 900 is presented by comparing its specifications to the predicate device.

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