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The Trinity ELE Plus and Trinity ELE Plus Pro devices are intended for facial stimulation and are indicated for over-the counter cosmetic use.

The Trinity ELE Plus comprises the Trinity ELE Plus device main body, a Trinity ELE Plus microcurrent attachment head, a charging cradle, and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the subject device as an accessory. The subject device and all its associated components and accessories are reusable and provided non-sterile.

The Trinity ELE Plus is a hand-held device that produces low levels of microcurrent which is discharged through two dual chrome-plated precise wands for aesthetic purposes. The device provides audible feedback to inform the user to relocate the device to treat a new location on the skin. The device also includes "hum" features to guide the user during the treatment cycle.

The subject device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle connects to a provided wall-mount power adaptor. Microcurrent output is cut-off while the device is sitting on the charging cradle either charging the battery or when the battery is fully charged.

The enclosures of the subject device main body, the attachment head and the charging cradle are made from injection molded ABS thermoplastic material. The same ABS material is used in other FDA-cleared devices. The dual chrome-plated precise wands on the attachment head use chromium. The same chromium material is used in the predicate device dual chrome-plated precise wands.

The subject device, including the attachment head, measures 6.1" H x 2.4" W x 1.2" D. The charging cradle measures 2.3" H x 3.0" W x 2.7" D.

The device includes an 'ON/OFF' multi-function button to turn the device on and off, start and stop treatment, increase or decrease the microcurrent output level and pair with a smart device. The device also includes a "BOOST" button that temporarily increases the microcurrent output level.

The device includes indicator LED's to provide information to the user on the status of the device and the progress of the treatment.

The subject device is the capable of pairing with compatible smart devices using Bluetooth Low Energy (BLE) wireless communications technology. This technology allows the subject device to communicate with other devices running the NūFACE® App which allows the user to select and run pre-programmed treatment profiles.

The Trinity ELE Plus provides microcurrent output at selected frequencies from 0.3 to 50 Hz.

The Trinity ELE Plus is available in two models, a Standard model and a 'Pro'' model. The Trinity ELE Plus Standard model has a maximum output current without Boost of 170 uA, and the Trinity ELE Plus Pro model has a maximum output current without Boost of 200 uA. All other aspects of the Trinity ELE Plus except those related to maximum output current, are the same between the Standard model and Pro models.

I regret to inform you that the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The document is a 510(k) premarket notification for the Trinity ELE Plus and Trinity ELE Plus Pro devices. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing and proving new acceptance criteria for the subject device itself.

Here's a breakdown of what the document does include and why it doesn't answer your specific questions:

• Indications for Use: The devices are intended for "facial stimulation" and are indicated for "over-the-counter cosmetic use."
• Technological Characteristics Comparison: There are tables comparing the subject device's features (Type of Energy Output, Energy Delivery, Energy Flow, Energy Output, Microcurrent Boost, Energy Power Source, Power Accessories, Charging Method, Charging Circuitry, Power Supply Type, Special Requirements, Wireless Technology, Output Frequency) and output specifications (Waveform Type, Shape, Max Output Voltage, Max Output Current, Output Tolerance, Pulse Period, Output Frequency, Beat Frequency, Symmetrical Phases, Phase Duration, Net Charge, Max Phase Charge, Max Current Density, Max Power Density, Burst mode information, ON time, OFF time) to those of a predicate device. Many of these are listed as "Same" or "Different," with explanations for why the "Different" aspects do not affect safety and effectiveness.
• Non-Clinical Performance Data:
  • Biocompatibility Evaluation: This describes the materials used and concludes they are biocompatible based on their use in other FDA-cleared devices or the predicate device.
  • Safety, Performance, and Bench Testing: This section states that EMC, Wireless Coexistence, and bench testing concluded the device "meets and complies with the safety and performance of the applicable standards and bench testing requirements." However, it does not list specific acceptance criteria for these tests or provide detailed results. It also mentions electrical safety tests are "currently being conducted and will be provided to the FDA before the subject device is released to market."
  • Software Verification and Validation: This states the software "meets and complies with the applicable software requirements specifications" but does not detail those specifications or acceptance criteria.
• No Animal Testing or Clinical Testing: The document explicitly states that substantial equivalence is not supported by animal or clinical testing.

Therefore, I cannot provide the requested table or answer the questions because the necessary data (specific acceptance criteria, detailed study results proving these criteria are met, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details) is not present in the provided text. The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device, not on proving its independent performance against new, explicit acceptance criteria.

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