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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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The Trinity Wrinkle Remover is an over-the-counter hand-held device intended for the use in the treatment of full-face wrinkles.

The Trinity Wrinkle Remover is an over-the-counter hand-held device for the use in the treatment of full-face wrinkles. It emits energy in the red and IR regions of the spectrum to reduce fine lines and wrinkles. The Subject device emits light energy at near identical levels as the Predicate device at the 605nm, 630nm, 660nm and 855nm wavelengths. The Subject device measured output spectral characteristics are identical to those of the Predicate device.

The device measures 3" W x 5.25" L x 1.25" D. Its outer case is injection molded of thermoplastic resin. The detachable Treatment Head comprises (36) Light Emitting Diodes (LED's) which emit light at the 605nm. 630nm. 660nm and 855nm wavelengths. The device is powered by 4 rechargeable batteries. The Trinity Wrinkle Remover comes with a Charging Cradle, which measures 3.25" W x 4" L x 3.25" D, to charge the internal batteries when not in use. The Charging Cradle is powered by d.c. power from a pre-approved wall-mount Power Supply provided with the device. All charging circuitry is contained within the handheld unit itself.

The Trinity Wrinkle Remover Treatment Head is designed for optimal contact with the face. The device continually pulses the LEDs output, and provides a fixed output intensity level. The device does not allow the output level to be changed. The '+' and '-' keys on the handle (main body) are not active when the Trinity Wrinkle Remover treatment Attachment is attached to the handle.

An ascending sequence of three audible beeps informs the User the device is ready for use. When the user turns off the device, a descending audible tone is emitted.

To promote proper use, a single audio beep every three minutes informs the user to relocate the device to treat a new location on the skin.

This query pertains to a 510(k) summary for the Trinity Wrinkle Remover, which is a medical device for reducing full-face wrinkles. The 510(k) summary focuses primarily on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria or extensive clinical study results as one might find in a PMA or a more comprehensive clinical trial report.

Based on the provided text, the device is an over-the-counter hand-held device intended for the treatment of full-face wrinkles. The substantiation for its effectiveness and safety, and thus its "acceptance criteria" from an FDA 510(k) perspective, is primarily based on its technological characteristics being substantially equivalent to legally marketed predicate devices.

Here's an attempt to answer your questions based on the available information:

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

The document does not explicitly state quantitative acceptance criteria for wrinkle reduction or specific cosmetic outcomes. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is therefore inferred to be similar to the cleared predicate devices.

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

The provided 510(k) summary does not contain information about a specific clinical study involving a test set of subjects for evaluating wrinkle reduction effectiveness. The substantiation is based on comparison to predicate devices, and compliance with electrical and photobiological safety standards. Therefore, "sample size" for a clinical test set is not applicable to the information given.

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)

This information is not provided in the 510(k) summary. Direct clinical evaluation with a ground truth established by experts is not detailed for this device within the document.

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

This information is not provided as there is no mention of a specific clinical test set for wrinkle reduction evaluation.

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

This type of study is not applicable to the "Trinity Wrinkle Remover," which is a light-based device for wrinkle reduction, not an AI-assisted diagnostic tool.

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

This refers to AI algorithm performance and is not applicable to this device.

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

For the direct evaluation of wrinkle reduction effectiveness of the Trinity Wrinkle Remover, this information is not provided in the document. The "ground truth" for the 510(k) is the established safety and efficacy profile of the predicate devices.

8. The sample size for the training set

This refers to AI model training and is not applicable to this device.

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

This refers to AI model training and is not applicable to this device.

Summary of Device and Study Information from the Document:

The provided document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. For the Trinity Wrinkle Remover, the primary "study" proving it meets acceptance criteria (i.e., is substantially equivalent and safe/effective for its intended use) is the comparison of its technological characteristics and intended use to those of previously cleared devices.

• Predicate Devices: The device claims substantial equivalence to two "Light for Wrinkles" devices (K101190 and K120775) manufactured by LED Intellectual Properties, LLC.
• Basis of Equivalence: The Trinity Wrinkle Remover has the same intended use (treatment of full-face wrinkles) and indications for use as the predicate devices. Technologically, it emits Red and IR energy at the same wavelengths (605nm, 630nm, 660nm, and 855nm) and similar intensities as the predicate device.
• Safety Compliance: The device underwent testing and was found compliant with international standards for photobiological safety (IEC 62471:2006), electromagnetic compatibility (IEC 60601-1-2), and electrical safety (IEC 60601-1). This demonstrates its safety characteristics, rather than direct efficacy for wrinkle reduction.
• Clinical Data: The 510(k) summary does not present clinical data from human subjects specifically demonstrating the efficacy of the Trinity Wrinkle Remover in reducing wrinkles. This is typical for 510(k) submissions where substantial equivalence to a predicate device with established efficacy is the primary pathway to market.

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