FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Summary

Regulation Number and Section

§ 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.