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Muscle relaxation and increased local blood circulation.

The TM20 is a device used for muscle relaxation. It sends biphasic pulses to targeted distressed muscles, and by delivering a specified sequence of timed and abrupt electrical frequency pulses, the device can be used to decrease the tension of the muscle fibers and leads to greater blood flow. The user operates the device by means of a keypad overlay. The overlay allows for the user to adjust the treatment length, adjust intensity of each stimulation output, adjust maximum power of stimulation, and start, pause, and stop treatment. The values being set and current stage of treatment is displayed to the user by means of an LCD display, alpha numeric displays, and LEDs. The TM20 device consists of the following: 1. User Interface Overlay 2. External Power Supply for TM20 3. A main board for controlling and monitoring the generated output 4. 10 Individual output channels, and a stimulation circuit for each channel 5. Communication and stimulation cables 6. A custom bent metal enclosure.

The provided text describes a 510(k) premarket notification for a medical device called MyoWorx TM20, a powered muscle stimulator. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document is a regulatory submission for a powered muscle stimulator, focusing on demonstrating substantial equivalence to a predicate device based on design, technology, and performance, rather than providing the kind of detailed study data typically associated with AI/ML device validation.

Specifically, the document focuses on:

• Device Description: What the MyoWorx TM20 is and how it works.
• Intended Use: Muscle relaxation and increased local blood circulation.
• Comparison to Predicate Device: A detailed side-by-side comparison of the MyoWorx TM20 with the Sys*Stim® 294 (ME294) across various technical specifications (e.g., number of output channels, power source, patient leakage current, electrical safety standards, operating conditions).
• Substantial Equivalence Conclusion: Argument that the MyoWorx TM20 is substantially equivalent despite some differences, emphasizing that these differences do not raise new issues of safety or effectiveness.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the provided text, as this information is not present. The document describes a "non-clinical performance study" in the "Substantial Equivalence Conclusion" section, but it does not provide details about the study design, sample size, ground truth, or specific acceptance criteria met. It merely states that "the data shows that the MyoWorx TM20 is substantially equivalent to the predicate."

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