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The Trinity Plus Wrinkle Reducer is an over-the-counter hand-held for reduction of full-face fine lines and wrinkles, and increase in local circulation within the perioral region.

The Trinity Plus Wrinkle Reducer (hereinafter referred to as "TWR Plus") comprises the TWR Plus main body, a TWR Plus light attachment head, a charging cradle, and a wall-mount power adaptor. The device and all its associated components are reusable and provided non-sterile.

The TWR Plus is a hand-held phototherapy device that emits Red and Infrared (IR) light energy in the 605, 630, 645, 660 and 855 nanometer wavelengths via a light attachment head. The light attachment head comprises (34) Light Emitting Diodes (LED's) which are the source of the light energy. The Red and IR light energy is used in the treatment of fine lines and wrinkles around eyes, mouth, and forehead and promotes local blood circulation.

The subject device includes three indicator LED's, one internal speaker and one vibration motor. These features provide visual, audible, and haptic feedback to the user during normal operation. The light attachment head includes a proximity sensor to detect when device is pressed onto the skin.

The subject device is turned on and turned off via a dedicated ON/OFF button. Once the subject device is ON, the user follows the provided Instructions for Use to start the treatment. The ON/OFF button also serves as a multi-function User Interface (UI) button by allowing the User to control other functions while the subject device is in Standby, Treating, Charging or Sleep modes. A long press of approximately one second on the ON/OFF button can stop treatment at any time.

Upon power up, the three indicator lights turn on and an ascending audible beep is emitted notifying the user that the device is ON. Once the device is ON, the light therapy LEDs are set to a visible, but significantly dimmed non-treatment state. As the device is placed in direct contact with the skin, the proximity sensor will turn the light therapy LEDs on to start the treatment. While in treatment, if the device is moved away from the skin, the device emits three beeps, and the LEDs revert to the significantly dimmed non-treatment state. The device also emits two beeps to inform the user when a treatment interval is complete and that it is time to treat another section of skin. The device automatically Shuts OFF after 24 minutes of use to indicate the treatment is complete.

The device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle is powered by a pre-approved wall-mount power supply. The light energy output power is zero watts while the device is in the charging cradle or when turned off. All charging circuitry is contained within the handheld unit itself.

The housings of TWR Plus main body, the light attachment head and the charging cradle are made from injection molded thermoplastic resins. The light attachment head, which is intended to come in contact with the skin, is made from a biocompatible polymer material. The TWR Plus, including the light attachment head, measures 5.4" H x 2.6" W x 1.7" D and weighs 7.8 oz. The charging cradle measures 2.3" H x 3.0" W x 2.7" D and weighs 7.30 oz.

The TWR Plus uses Bluetooth Low Energy (BLE) wireless technology to pair to and connect with compatible devices capable of running the NuFACE® App. The NuFACE® App allows the user to select and run pre-programmed treatment profiles stored in the device.

Device component list:

• 1 x TWR Plus Main Body
• 1 x TWR Plus Light Attachment Head
• 1 x Wireless Charging Cradle
• 1 x Pre-approved wall-mount power adaptor

The provided text is a 510(k) Summary for the NuFACE® Trinity Plus Wrinkle Reducer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the detailed performance metrics through rigorous clinical studies often associated with novel or high-risk devices. As such, the information typically requested in your prompt (e.g., acceptance criteria for clinical performance, sample sizes for test sets, expert qualifications, MRMC studies, specific ground truth types) is largely absent because it was not required for this type of submission.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria for clinical performance (e.g., specific percentage reduction of wrinkles, or circulation increase metrics) nor does it report device performance in those terms. Instead, the "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device is as safe and effective as a predicate device.

The reported "performance" is concluded through:

• Biocompatibility Evaluation: The materials (ABS Thermoplastic and a Polymer for the lens) were deemed biocompatible for surface device, intact skin, limited (<24h) duration contact. Specific performance metrics are not given, only the conclusion of biocompatibility.
• Safety, Performance and Bench Testing (Optical Safety, Electrical Safety, EMC, Wireless Coexistence): The conclusion is that the device "meets and complies with the safety and performance of the applicable standards and bench testing requirements." No specific quantitative results or acceptance thresholds are provided in this summary.
• Software Verification and Validation: Concluded that the device "meets and complies with the applicable software requirements specifications." No detailed performance metrics are given.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: No information on a "test set" in the context of clinical performance is provided because no clinical testing was performed or deemed necessary to support substantial equivalence.
• Data Provenance: Not applicable as no clinical data for performance assessment (wrinkle reduction/circulation increase) was collected for this submission. The non-clinical testing data provenance is not specified (e.g., in-house labs, certified external labs).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set with human "ground truth" establishment was performed or reported for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was performed.

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

Not applicable. This device is a direct-to-consumer medical device for wrinkle reduction and local circulation increase, not an AI-assisted diagnostic or interpretative system that would involve human "readers" or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not relevant to the device described. The device is a physical light therapy device, not an algorithm. Its performance is measured by its physical output and safety, and by comparing its technological characteristics to a predicate device, not by an algorithm's classification performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable for clinical performance. For the non-clinical tests (biocompatibility, electrical/optical safety, EMC, software), the "ground truth" is adherence to established industry standards and internal design specifications.

8. The sample size for the training set

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

9. How the ground truth for the training set was established

Not applicable.

Summary of Device Performance and 510(k) Claims:

The 510(k) submission for the Trinity Plus Wrinkle Reducer relies on demonstrating substantial equivalence to existing predicate devices (NuFACE® Trinity Wrinkle Remover K120560 and reVive Perioral LED Light Therapy System K172662). This regulatory pathway often does not require new clinical studies if the technological characteristics and indications for use are similar to a predicate device that has already established its safety and effectiveness.

The "study that proves the device meets the acceptance criteria" in this context is the compilation of non-clinical performance data and the comparison to predicate devices:

• Biocompatibility Evaluation: Concluded the materials are biocompatible based on industry standards and prior use in other FDA-cleared devices.
• Safety, Performance and Bench Testing (Optical Safety, Electrical Safety, EMC, Wireless Coexistence): Concluded compliance with applicable standards.
• Software Verification and Validation: Concluded compliance with software requirements.

The core argument for acceptance is presented in Section 8, "Overall Conclusion":
"The documentation and test results provided in this submission and comparison of intended use, principle of operation, performance data, design and the overall technological characteristics, demonstrate that the NuFACE® Trinity Plus Wrinkle Reducer device is substantially equivalent to the predicate device."

Therefore, the "acceptance criteria" here relate to meeting the necessary non-clinical standards and successfully demonstrating equivalence to a predicate, rather than achieving specific performance thresholds in a de novo clinical trial.

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