Search Results

The Nive for Wrinkles is an Over-the-Counter (OTC) device intended for the use in treating full-face wrinkles.

The Nüve for Wrinkles is an over-the-counter hand-held light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and fine lines. The device uses four types of LEDs : 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adiustments required.

The Nuve for Wrinkles system components include the handheld unit containing the LED module , power supply, goggles, 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 document is a 510(k) summary for the NUVE FOR WRINKLES device. It outlines the device description, indications for use, comparison to predicate devices, and performance testing. However, it does not contain specific acceptance criteria for performance metrics (such as accuracy, sensitivity, specificity, etc.) related to its effectiveness in treating wrinkles, nor does it detail a clinical study with a control group or comparative effectiveness against human readers.

The performance testing section focuses on safety, functional performance, software validation, and usability, rather than clinical efficacy measured against specific criteria.

Therefore, many of the requested information points, especially those pertaining to clinical efficacy, ground truth, expert adjudication, and MRMC studies, cannot be extracted from this document as they are not present.

Here's the information that can be extracted, and where applicable, a note stating that the information is not available in the provided document:

Acceptance Criteria and Reported Device Performance

Study Details

• Sample size used for the test set and the data provenance:

  • A "Usability Study" was conducted with 38 participants.
  • The document does not specify the provenance of these participants (e.g., country of origin). It's a usability study, not a clinical efficacy study with data related to wrinkle reduction.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable as this was a usability study demonstrating the ability of participants to use the device and demonstrate a light sensitivity test, not a study establishing ground truth for clinical efficacy of wrinkle reduction.

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

  • Not applicable. The usability study evaluated user interaction, not clinical outcomes requiring adjudication.

• 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:

  • No, an MRMC comparative effectiveness study was not done. This device is a light-emitting diode (LED) device for wrinkle reduction, not an AI-assisted diagnostic tool involving human readers.

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

  • Not applicable. This is a physical device, not an algorithm. Its performance is inherent to its physical operation and user interaction, not an AI algorithm.

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

  • For the usability study, the "ground truth" was whether participants could successfully perform a light sensitivity test and use the device. This is a direct observation of user interaction, not a medical "ground truth" like pathology or expert consensus on disease.
  • For efficacy, the document does not present clinical trial data with defined ground truth for wrinkle reduction. The claim of effectiveness is based on substantial equivalence to predicate devices which presumably had such data in their original submissions.

• The sample size for the training set:

  • Not applicable. This document is for a hardware device, not a machine learning algorithm that requires a training set.

• How the ground truth for the training set was established:

  • Not applicable for the reason above.

Ask a specific question about this device

Intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Indicated as an over-the-counter phototherapy device for the treatment of mild to moderate acne.

The dpl® Nüve is a lightweight, handheld, light emitting diode (LED) device with interchangeable heads which emit light energy. A blue LED head in the 415 nm spectrum is used in treatment for mild to moderate inflammatory acne. A red head at 625 nm and a purple head (infrared) in the 830 nm spectrum are used in combination for reduction of periorbital wrinkles. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature

The provided text does not contain information about acceptance criteria for the device's performance in treating periorbital wrinkles or acne, nor does it detail a study proving the device meets specific performance criteria.

Instead, the document focuses on:

1. Substantial Equivalence: The primary assertion is that the dpl® Nüve is "substantially equivalent in function and technology" to predicate devices (Omnilux New U for wrinkles and Tanda Skin Care for acne). This means the device is considered as safe and effective as existing legally marketed devices, rather than meeting specific quantifiable performance benchmarks detailed in the submission.
2. Safety Testing: The device's safety is demonstrated by meeting general electrical safety standards (IEC 60601-1, EN 60601-1-2, EN 60601-2-22) and patient contact material safety (ISO 10993).
3. Intended Use/Indications for Use: These describe the therapeutic areas the device is cleared for (periorbital wrinkles and mild to moderate acne).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and performance study details based on the provided text. The document does not describe a clinical study with quantifiable performance metrics, sample sizes, expert ground truth, or an MRMC study.

Ask a specific question about this device