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The device is indicated to be used for:

• · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks and thighs.

The Electromagnetic stimulator device consists of a host, hand tools and power cord. The host contains a power supply unit, a control unit, and a cooling unit. The control unit includes a control element and a liquid crystal display. The hand tools include electromagnetic induction coils and cooling fans, it is a non-invasive therapeutic device.
The subject device has two models, Tesla Duet and EM contouring. The two models are exactly the same except for the color of the host shell, one is black and other is white.
The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the Electromagnetic stimulator device helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device two outputs enable simultaneous treatment by two applicators.
The Electromagnetic stimulator device is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen and buttons on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

The provided document is a 510(k) summary for a medical device (Electromagnetic Stimulator Device). It details the device's characteristics and its equivalence to a predicate device. However, it explicitly states "No clinical study is included in this submission" under section 8.0 Clinical Test Conclusion and that "Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness." Therefore, the document does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

The submission focuses primarily on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics, rather than reporting on a standalone clinical study with acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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