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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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