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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:

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.

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The GentleWaves LED Photomodulation Device is indicated/intended for use in the treatment of periorbital wrinkles and rhytides.

Not Found

This FDA 510(k) clearance letter for the GentleWaves LED Photomodulation Device does not contain the detailed information necessary to complete most of your request regarding acceptance criteria and study particulars. The letter primarily confirms substantial equivalence to a predicate device for marketing purposes and specifies the intended use.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not specified in the provided document. A 510(k) clearance letter does not typically detail the specific performance metrics or acceptance thresholds for a device, beyond confirming its "substantial equivalence" to a predicate device.
• Reported Device Performance: Not included in the provided document.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). These details would typically be found in the clinical study report, not the clearance letter.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Number of Experts: Not specified.
• Qualifications: Not specified.

4. Adjudication Method for the Test Set:

• Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

• No mention of an MRMC study or comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

• The device is a physical LED photomodulation device for treatment, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable in this context.

7. The Type of Ground Truth Used:

• Not specified. For a device treating wrinkles, ground truth could involve clinical assessments (e.g., blinded physician ratings, photographic analysis, objective measures like skin elasticity), but this is not detailed here.

8. The Sample Size for the Training Set:

• Not applicable as this is a physical medical device, not an AI algorithm requiring a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable for the same reason as point 8.

Summary of available information:

• Device Name: GentleWaves LED Photomodulation Device
• Indicated Use: Treatment of periorbital wrinkles and rhytides.
• Regulatory Basis for Clearance: Substantial equivalence to a legally marketed predicate device, not necessarily based on a new, comprehensive clinical study detailed in this letter.

To obtain the detailed information you are requesting (acceptance criteria, study design, sample sizes, ground truth methodology, etc.), you would need to access the full 510(k) summary and potentially the underlying clinical study reports submitted to the FDA for this device, which are not part of this clearance letter.

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