(504 days)
The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.
The GentleWaves Consumer is a hand-held device consisting of a low intensity light emitting diode (LED) lamp placed in contact with the skin at a fixed distance determined by its lens cover. The device components include an LED array, a lens, a handpiece, three circuit boards, a power supply enclosure and power supply.
The provided text describes a 510(k) summary for the GentleWaves Consumer LED Photomodulation Device (K062991). However, it does not contain the information requested regarding specific acceptance criteria, a detailed study proving the device meets criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for this device.
The document indicates that the performance and safety testing obtained for the predicate device, Light BioScience, LLC's GentleWaves LED Photomodulation System (K031425), is considered "fully applicable to the GentleWaves Consumer" because the spectral content is not significantly different. A "user study" was mentioned for the GentleWaves Consumer to confirm lay users could follow instructions, but no further details on this study's methodology or results are provided beyond its existence.
Therefore, I cannot populate the table or answer the specific questions based on the provided text.
Here is the information that can be extracted, and an explanation of what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than defining specific performance acceptance criteria for this new device. | The device demonstrates "no significant difference in spectral content as compared to the cleared GentleWaves device (K031425)." Additionally, a user study confirmed "lay users were able to use the GentleWaves Consumer in accordance with its instructions for use." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified for the user study. For the primary performance claim, it relies on data from the predicate device (K031425), but the provenance of that predicate device's data is also not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's unclear if expert-established ground truth was even used for the user study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: No, an MRMC comparative effectiveness study involving AI assistance is not mentioned for this device. This device is an LED photomodulation device for wrinkles, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable and not mentioned. This is a therapeutic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the "user study," the ground truth likely related to the ability of lay users to successfully operate the device according to instructions. The specific type (e.g., direct observation, survey results) is not detailed. For the efficacy claim, it relies on the predicate device's established efficacy, but the ground truth for that is not provided here.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. This is not an AI/algorithm-based device.
Summary of Device's Performance Claims (based on the provided text):
The GentleWaves Consumer LED Photomodulation Device's performance is primarily established by its substantial equivalence to its predicate device, the GentleWaves LED Photomodulation System (K031425).
- Key Performance Claim: No significant difference in spectral content between the GentleWaves Consumer and the predicate GentleWaves device. This implies that the therapeutic effect, based on light emission, is assumed to be equivalent.
- User Study: A user study was conducted to confirm that lay (over-the-counter) users could operate the device correctly per its instructions. No specific results, sample sizes, or methods beyond its existence are detailed in this summary.
The document emphasizes that because the new device's technological characteristics (specifically spectral content) are not significantly different from the predicate, the established safety and performance data of the predicate can be applied to the new device.
§ 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.