(153 days)
The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 801 Subpart C).
The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 807 Subpart C).
The Trinity ELE is a non-invasive at home, over-the-counter facial stimulation device. The dual spheres of the Trinity ELE are designed for optimal contact with smaller surface areas of the face. The Trinity ELE is extremely responsive as it delivers soft wave micro-current in the millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles. The Trinity ELE continually alternates between the positive and negative probes, and allows the user to adjust settings from approximately 53 to 192 microamps for a personalized comfort level.
The Trinity ELE measures 2.8" W x 6.2" L x 1.3" D. Its outer case is injection molded of thermoplastic resin. The device comes with a Charging Cradle, which measures 3.1" W x 4.0" L x 3.3" D, to charge the internal batteries of the main body when not in use. The Charging Cradle is powered by DC power from a pre-approved wall adapter Power Supply provided with the device. All charging circuitry is contained within the main body unit itself.
An ascending sequence of beeps informs the customer the Trinity ELE is ready for use. When the user turns off the device, a descending tone is emitted.
To promote proper use, a single audio beep informs the user to relocate the device to treat a new location on the skin. The user can also adjust output by pressing the + or - intensity buttons to increase or decrease the micro-current output.
The provided text is a 510(k) summary for the Trinity ELE Device, which is a facial stimulation device. The document primarily focuses on establishing substantial equivalence to a predicate device (NuFACE® Trinity) through a comparison of technological characteristics and output specifications. It does not describe a clinical study or performance data against specific acceptance criteria for efficacy in the same way a diagnostic or therapeutic device might.
Instead, the "acceptance criteria" here are based on demonstrating that the new device (Trinity ELE) is substantially equivalent to a previously cleared device (NuFACE® Trinity), meaning it is as safe and effective. The study that proves this is a non-clinical performance assessment, specifically a direct comparison of the electrical output characteristics of the new device to the predicate device.
Here's a breakdown of the requested information based on the provided text:
1- A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission based on technical characteristics, the "acceptance criteria" can be interpreted as the characteristics of the predicate device. The "reported device performance" is how the Trinity ELE compares to those.
| Acceptance Criteria (Predicate Device K103472: NuFACE® Trinity) | Reported Device Performance (Trinity ELE K131251) | Assessment |
|---|---|---|
| Waveform type: Pulsed Biphasic | Pulsed Biphasic | Identical to predicate |
| Waveform Shape: Modulated Square | Modulated Square | Identical to predicate |
| Max Output Voltage (e.g., 137 mV @ 500 Ω) | Lower (e.g., 96 mV @ 500 Ω) | Less than predicate, but justified by maintaining identical current density with smaller electrodes. |
| Max Output Current (e.g., 274 μA @ 500 Ω) | Lower (e.g., 193 μA @ 500 Ω) | Less than predicate, but justified by maintaining identical current density with smaller electrodes. |
| Output Tolerance: +/- 2% | +/- 5% | Note: The document states "Output Tolerance is identical to the predicate" in the narrative but shows different values in the table (5% vs 2%). This discrepancy needs clarification. However, the narrative claims identicality. |
| Pulse Width: 60 ms | 60 ms | Identical to predicate |
| Frequency: 8.33 Hz | 8.33 Hz | Identical to predicate |
| Max Phase Charge (e.g., 23.9 µC @ 500 Ω) | Lower (e.g., 11.5 µC @ 500 Ω) | Less than predicate, but justified by maintaining identical current density with smaller electrodes. |
| Max Current Density (e.g., 0.518 mA/cm² @ 500 Ω) | 0.739 mA/cm² @ 500 Ω | Note: The narrative states "Max Current Density is identical to the predicate" multiple times, but the table shows a higher value for the Trinity ELE. This discrepancy needs clarification. However, the narrative claims identicality. |
| Max Power Density (e.g., 1423 µW/cm² @ 500 Ω) | Lower (e.g., 1420 µW/cm² @ 500 Ω) | Less than predicate, but justified by maintaining identical current density with smaller electrodes. |
| Burst Mode (Pulses per burst): 20 | 20 | Identical to predicate |
| Burst Mode (Pulses per second): 8.3 | 8.3 | Identical to predicate |
| Burst Mode (Burst duration): 2.4 | 2.4 | Identical to predicate |
| Burst Mode (Duty Cycle): 20 | 20 | Identical to predicate |
| ON Time: Constant | Constant | Identical to predicate |
| OFF Time: None | None | Identical to predicate |
Summary of Device Performance against "Acceptance Criteria": The Trinity ELE device was found to have identical waveform type, waveform shape, pulse width, frequency, burst mode characteristics, ON/OFF times, and (according to the narrative) output tolerance, maximum current density, maximum output voltage, maximum output current, maximum phase charge, and maximum power density after accounting for the smaller electrode size to achieve the same current density. The output voltage, current, phase charge, and power density are listed as lower than the predicate, which the applicant justifies as a necessary consequence of smaller electrodes to maintain identical current density, which is the key metric for tissue interaction.
2- Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This was a non-clinical performance assessment comparing device specifications, not a study involving human subjects or real-world data to generate a test set.
- Data Provenance: The data is technical specification comparison between the Trinity ELE (new device) and the NuFACE® Trinity (predicate device), presumably obtained through laboratory testing of both devices. There is no mention of country of origin for data or whether it's retrospective/prospective in the context of clinical data, as this is hardware specification testing.
3- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in this context, would be the measured electrical output specifications of the predicate device, which are inherent to the device's design and operation, not derived from expert consensus on observations.
- Qualifications of Experts: Not applicable.
4- Adjudication method for the test set
- Adjudication Method: Not applicable. This was a comparison of device specifications, not a clinical study requiring adjudication of outcomes or diagnoses.
5- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, entirely not applicable. This is a submission for a Transcutaneous Electrical Nerve Stimulator, not an AI-assisted diagnostic or imaging device.
6- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical stimulating device, not a software algorithm. The comparison was of the device's inherent electrical output.
7- The type of ground truth used
- Type of Ground Truth: The "ground truth" for this substantial equivalence claim is the measured electrical output specifications and physical design characteristics of the legally marketed predicate device (NuFACE® Trinity). The new device's specifications are compared directly against these established characteristics to demonstrate equivalence.
8- The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not involve machine learning or a training set in the conventional sense.
9- How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set described.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).