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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.

Comments on Discrepancies:

• Max Output Current: The ELECTROMEDICARIN 900 reports higher maximum output current (± 90 mA) than the predicate (± 70 mA). The FDA still deemed it substantially equivalent, suggesting this difference was not considered a significant safety or effectiveness concern in this context.
• Pulse Width & Frequency: The ELECTROMEDICARIN 900 offers a wider range for pulse width (10-500 μs vs 20-500 μs) and frequency (0.3-1000 Hz vs 1-200 Hz).
• Number of Channels: The ELECTROMEDICARIN 900 has 3 channels, while the predicate has 4.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. This is not a study involving a test set of patient data, but a comparison of device specifications.
• Data Provenance: Not applicable. The data is a comparison of technical specifications from the applicant and the predicate device's existing 510(k) information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This device is an electrostimulator, not an AI diagnostic imaging tool or a system involving human readers in the way an MRMC study would apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Study: No. This device is an electrostimulator. Its "performance" is primarily defined by its electrical output characteristics and safety, not by an algorithm's diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable in the sense of clinical "ground truth." The "ground truth" for this submission is the established safety and effectiveness of the predicate device and compliance with relevant electrical and medical device standards (e.g., IEC 60601-1). The "proof" is that the new device's specifications meet or are substantially equivalent to those of the predicate and conform to pertinent standards.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. As this is not an AI/ML device, there is no "training set."

9. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable.

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