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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 (

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The Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.

The Elevare Plus is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and I/R spectrum for the treatment of wrinkles on the face. The system components include the handheld unit containing the LED array, 2 Li-ion rechargeable batteries, power adapter, charging cord, charging cradle and travel case.

The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).

The provided text does not contain information about acceptance criteria or a study that proves the device meets the acceptance criteria in the way typically found for AI/ML medical devices. The document is a 510(k) summary for a light-based device (Elevare Plus) intended for wrinkle reduction, and its focus is on demonstrating substantial equivalence to predicate devices based on safety and performance testing, rather than a clinical study with detailed performance metrics against a defined acceptance criterion.

However, I can extract the relevant information from the document that pertains to how the device's performance was evaluated and compared, even if it doesn't align perfectly with the structure requested for AI/ML device studies.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical efficacy endpoints or statistical thresholds for AI/ML performance. Instead, it demonstrates performance through technical specifications and comparison to predicate devices. The "acceptance criteria" are implied to be meeting technical specifications and demonstrating "substantial equivalence" to other legally marketed devices.

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

• Test Set Sample Size: For "Skin Temperature Testing", two devices were tested. For "Predicate Comparison Testing," "several FDA cleared devices" were evaluated against the Elevare Plus device. No other specific sample sizes for testing are mentioned.
• Data Provenance: The testing appears to be prospective bench testing and performance testing conducted by the manufacturer specifically for this submission. The origin of the data (country) is not explicitly stated but is implied to be part of the manufacturer's testing efforts.

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

This type of information is generally not applicable to a submission for a physical device like the Elevare Plus, which relies on technical performance and safety testing rather than interpretation of data by human experts for ground truth. The "ground truth" here is defined by physical measurements against established engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. The testing described involves objective measurements against established standards, not interpretation or adjudication by multiple human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for assessing the diagnostic performance of an AI system, often comparing AI-assisted vs. unassisted human performance. This document describes the safety and engineering performance of a physical light therapy device, not an AI/ML diagnostic algorithm.

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

This refers to AI/ML algorithm performance. The Elevare Plus is a physical device, not an AI/ML algorithm, so this concept is not applicable.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation described in this summary consisted of:

• International consensus standards for electrical safety, EMC, biocompatibility, photobiological safety, and home healthcare environments.
• Manufacturer's internal specifications for software validation, skin temperature limits (41+/- 2 ºC, not above 43ºC), and wavelength/power output.
• Technical characteristics and documented performance of legally marketed predicate and reference devices (as detailed in their 510(k) summaries) for comparison purposes to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The Elevare Plus is a physical light therapy device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device submission.

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