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The SLENDERTONE® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

The SLENDERTONE® Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains twelve pre-installed programs.

The control unit is connected to the abdominal belt garment via three magnetic connectors. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on or off and to increase or decrease the stimulation intensity. The SLENDERTONE® Evolve Abs, Type 735 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

The SLENDERTONE® Evolve Abs, Type 735 is rated as IP22 for ingress protection. The user has no access to the wiring or connectors within the garment. For purposes of hygiene, the garment may be cleaned and instructions for garment care are included in the user manual.

The provided document is a 510(k) summary for the SLENDERTONE® Evolve Abs, Type 735, a powered muscle stimulator. It does not contain information about a clinical study or acceptance criteria based on human performance or AI performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SLENDERTONE® Corefit Abs8, Type 734) by comparing technological characteristics and citing compliance with safety standards.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies for this specific device based on the given text.

The document states:

• Indications for Use: Improvement of abdominal muscle tone, strengthening of abdominal muscles, and development of a firmer abdomen.
• Performance Data (Safety Standards): The device complies with several international safety standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, and IEC 62133 for batteries). These standards typically involve engineering and electrical safety tests, not clinical efficacy studies for the stated indications.
• Conclusion: The device is considered substantially equivalent to the predicate device, and any differences in technological characteristics do not raise new issues of safety or effectiveness.

To answer your request, a clinical study demonstrating the efficacy of this specific device for its indications would be required, which is not present in this 510(k) summary. The document explicitly states "Performance data has demonstrated that the SLENDERTONE® Evolve Abs, Type 735 is as safe and effective as the predicate device and is substantially equivalent," but this "performance data" refers to compliance with electrical and safety standards, not a clinical trial proving its effectiveness in improving muscle tone or firmness.

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