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The NuFACE® Mini Plus device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

The NuFACE® Mini Plus (subject device) comprises the Mini Plus device itself and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the device as an accessory. The Instructions for Use (IFU) are also included with the device and all its associated components are reusable and provided non-sterile.

The subject device produces low levels of microcurrent that is discharged through two chrome-plated spheres when they come in contact with and are glided over the skin being treated.

The subject device allows the user to turn on and turn off the device at any time during the treatment. Once the device is on, the user can select different microcurrent intensity levels. The device provides visual (lights), audible (beeps) and haptic (hum) feedback to guide the user during treatment. The device will shut off automatically after 20 minutes of use.

The subject device is powered by one internal rechargeable, non-removable battery which is charged via the provided wall-mount power adaptor. During battery charging the device microcurrent output is disabled to prevent accidental and/or intentional use.

The subject device is capable of pairing and connecting to compatible smart devices using Bluetooth Low Energy (BLE) technology. BLE allows the subject device to wirelessly communicate with other devices such a smart phone running the NuFACE® App. The NuFACE® App allows the user to customize treatment options.

The subject device is made from thermoplastic and metal materials already used in other FDA-cleared medical devices. The device measures 2.7" W x 3.6" L x 2.6" D.

This document is a 510(k) premarket notification for the NuFACE Mini Plus, a cosmetic device. It focuses on demonstrating substantial equivalence to a predicate device (NuFACE Mini) rather than presenting a clinical study to prove the device meets acceptance criteria for a medical diagnosis or treatment.

Therefore, many of the requested details, such as sample size for test/training sets, expert qualifications, ground truth establishment methods (for medical conditions), MRMC studies, or effect sizes for human readers, are not applicable to the information provided in this regulatory submission.

The document primarily addresses non-clinical performance data to show that the new device is as safe and effective as the predicate device, not that it meets specific diagnostic or treatment accuracy acceptance criteria as one might expect for an AI-enabled diagnostic device.

Here's a breakdown of the available information based on your request, explaining why certain points are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table in the sense of diagnostic accuracy (e.g., sensitivity, specificity, AUC) against clinical ground truth. Instead, it compares the technical specifications and safety/performance testing results of the subject device (NuFACE Mini Plus) to its predicate device (NuFACE Mini) to demonstrate substantial equivalence.

Here's a table summarizing the primary comparisons, which serve as the "performance" demonstrated for this type of device submission:

Differences and Justification:

• Output Frequency (Hz): Subject device (Variable: 0.3 - 50 Hz) vs. Predicate (Fixed: Approximately 8.3 Hz). This is a difference, but likely justified through safety testing and remaining within general microcurrent parameters.
• Wireless Technologies: Subject device has Bluetooth Low Energy (BLE) vs. Predicate (None). This is a new feature, addressed by software verification and wireless coexistence testing.
• Pulse Period (Pulse Width): Subject device (Varies with Output Frequency) vs. Predicate (60 msec). Related to the variable frequency.
• Output Frequency (Hz): Subject device (0.3 - 50 Hz (Variable)) vs. Predicate (Approximately 8.3 Hz). Explained above.
• Microcurrent Output (Device OFF / Not Stimulating): Subject device (< 10 µA) vs. Predicate (< 1 µA). Both are very low and considered safe for an "off" state.
• Pulses Per Second: Subject device (Variable) vs. Predicate (8.3). Related to the variable frequency.
• Burst Duration (sec): Subject device (Variable) vs. Predicate (2.4 sec). Related to the variable frequency.

The document argues that these differences do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance:

• Test Set (for performance comparison): Not applicable in the context of clinical data for diagnostic performance. The "test set" here refers to the actual subject device undergoing various non-clinical engineering and safety tests.
• Data Provenance: The tests are conducted internally by the manufacturer or by third-party testing labs. No information on country of origin for the data is provided, as it's not a clinical data set. The tests are "prospective" in the sense that they were performed specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. This device does not generate a diagnostic output requiring expert interpretation for ground truth. Ground truth for engineering tests is established by calibrated measurement devices and compliance with industry standards.

4. Adjudication Method for the Test Set:

• Not applicable. There's no human interpretation or subjective assessment of outcomes that would require adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is not an AI-enabled diagnostic imaging device or one that involves human readers interpreting results.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance:

• Not applicable in the typical sense of an algorithm making a medical diagnosis. The device's "performance" is its ability to generate microcurrent within specified parameters safely, as measured by bench testing. The software component, which controls the device, undergoes verification and validation to ensure it operates correctly according to its specifications.

7. The Type of Ground Truth Used:

• For Biocompatibility: Compliance with ISO 10993-1 categorization based on material type, contact, and duration, and prior FDA clearance of identical materials.
• For Electrical Safety/EMC: Compliance with applicable (IEC) standards, measured using calibrated test equipment.
• For Performance Bench Testing: Measured electrical outputs (voltage, current, frequency, etc.) compared to internal design specifications and the predicate device's specifications, using calibrated test equipment.
• For Software Verification and Validation: Software requirements, design specifications, and risk mitigations (i.e., whether the software behaves as intended and safely).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

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