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UltraSlim DIGITAL is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

UltraSlim DIGITAL is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.

UltraSmooth DIGITAL is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The Massager component is indicated for the temporary reduction in the appearance of cellulite.

UltraSlim® Digital and UltraSmooth® Digital are LED light therapy devices. The UltraSlim Digital uses 625nm red light (UltraSlim Digital), and the UltraSmooth Digital uses 532nm green light (UltraSmooth Digitial). The devices are generally described as pole-mounted and free-standing on a rolling base as shown in the figures below.

Both devices, UltraSlim® Digital and UltraSmooth® Digital, continue to share the same design platform, and only differ in the color of the LED light array. The associated branding/names, warning labels, and differences due to their respective indications for use will remain the same as previously cleared, and do not change as a result of this proposed controller change.

All design and manufacturing parameters are very similar in both devices including the power supply, drivers, internal components, physical form, and control. The devices consist of a main control unit, LED panel, and cable connections. The main control unit contains the main input, fuses, power supply, control circuits, and Minutes selector switch. The power switch has a failsafe system that ensures the voltage from a wall socket can never come in contact with the user. A hospital-approved isolation transformer is mounted on the base of the medical pole cart whose low center of gravity also supports the main control unit and the light fixture from tipping. The console is mounted to the pole with an articulated arm. Treatment time is selected from pre-determined options programmed into the digital timer relay that do not allow the user to vary treatment times. System operation is preset. Both units operate at a frequency of 50Hz – 60Hz and a total power output of 300 W.

A design change was implemented, in an identical way, in the control of both devices that changes the unit from manual control to WiFi control. In general terms, the design change effectively replaces the electronic relay from the old design with a WiFi relay switch that is activated via WiFi from a mobile, desktop, tablet, or laptop device.

The new control design centers around replacing the manual time interval select and start button with a 4-Channel WiFi Relay Switch. Initiating a start sequence of the unit will be performed via internet control using a Relay Switch that receives its instructions from the user through WiFi control. Users continue to be restricted to the treatment time options of 8 and 20 minutes in the web app, and are able to start the device from the WiFi control.

The push button momentary start switch is removed in the new design. Users only have the ability to start the device by way of WiFi control.

The devices with the new design change do not contain any software. However, a web app accessible through the internet allows users to log in, select treatment time options of 8 minutes or 20 minutes, and to initiate treatment. The built-in timer control via the 4-Channel WiFi Relay Switch automatically stops the treatment at the end of the approved treatment time based upon the input received from the user.

Each device has a unique local IP address that is associated with its assigned router. Each router has its own unique client's ISP-assigned Static IP and may be controlled by WiFi from any phone, tablet, or computer with Internet access.

I am sorry, but the provided text does not contain information regarding a study that proves the device meets specific acceptance criteria in the way you've outlined for clinical performance. The document explicitly states:

• "No new Clinical Testing was conducted." (page 8)
• "The submission does not contain clinical performance data." (page 8)

The document is a 510(k) summary for a premarket notification for device modifications (changing from manual control to WiFi control) for existing devices (UltraSlim® Digital and UltraSmooth® Digital). The focus is on demonstrating substantial equivalence to predicate devices and compliance with non-clinical performance standards and safety evaluations for the design change, rather than providing new clinical data for acceptance criteria directly related to the treatment efficacy.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance for clinical efficacy, as this information is not present in the provided text.

The information I can extract that is somewhat related to your request, but not directly for clinical acceptance criteria, pertains to non-clinical testing for the design change:

• Non-Clinical Performance Data: The device was tested for compliance with applicable standards given in the "Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use." This includes IEC 60601-2-57 (Medical electrical equipment for basic safety and essential performance of non-laser light source equipment).
• Electromagnetic Disturbances and Wireless Compliance: Testing was conducted by SGS in Suwannee, Georgia, to ensure compliance with IEC 60601-1-2:2014 (Electromagnetic disturbances) and ANSI C63.10: 2013 (FCC Part 15 Subpart C, § 15.247) for RF emissions due to the addition of a 4-Channel WiFi Relay Switch. All test results were compliant.
• Software Validation: The web app control for logging in and initiating treatments was validated.
• Cybersecurity: A risk-based cybersecurity safety evaluation was performed, and the device was classified as Tier 2 "Standard Cybersecurity Risk."

These points demonstrate compliance with certain safety and performance standards for the device's design and control system, but they are not clinical acceptance criteria for the device's intended aesthetic treatment efficacy (e.g., reduction of circumference).

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