(328 days)
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
| Acceptance Criteria (Not explicitly stated for clinical efficacy) | Reported Device Performance (Focus on safety, usability, and functionality) |
|---|---|
| Safe operation (implicitly, from standards compliance) | Conforms to IEC 60601-1, IEC 60601-1-2, ISO 10993-10, IEC 60825-1 (Safety and electrical standards) |
| Functional performance (not specified beyond "performs as intended") | Not explicitly quantified; "system performs as intended" is stated. |
| Software validation (implicitly, from guidance compliance) | Tested and validated in accordance with FDA guidance for software in medical devices. |
| User ability to demonstrate light sensitivity test | 100% of participants were able to demonstrate the light sensitivity test. |
| User ability to use the device successfully | 100% of participants were able to use the device successfully. |
| Substantial equivalence to predicate devices (regarding indications, output, wavelengths, treatment duration, and regimen) | Same intended use, similar output (65 mW/cm²), same number of wavelengths (4 between 605 nm - 880 nm), same treatment duration (180 seconds), same treatment regimen (5 days/week for 8 weeks) as predicate devices. |
Study Details
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable for the reason above.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.