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

The dpl® IIa Panel system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses five types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared, and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The dpl® IIa Panel system components include the panel unit containing the LED module, power supply, goggles, and storage 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).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the dpl® IIa Panel, an over-the-counter LED device intended for treating wrinkles and mild to moderate inflammatory acne.

Based on the provided information, the document does not contain acceptance criteria or a study proving the device meets performance criteria in the way typically expected for a medical device efficacy study against specific clinical endpoints. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving independent efficacy against predefined performance metrics.

Here's an analysis based on the structure of the request, highlighting what is and isn't available in the text:

A table of acceptance criteria and the reported device performance:
The document does not present a table of specific acceptance criteria for clinical performance (e.g., X% reduction in wrinkle count, Y% clearance of acne lesions). Instead, it primarily focuses on comparing the technological characteristics of the dpl® IIa Panel to predicate devices. The "reported device performance" in this context refers to its operational parameters rather than clinical outcomes.

Characteristic	dpl® IIa Panel (Reported Performance - Technological)	Predicate Device (Example: dpl® II Panel, K171390)
Intended Use	Treatment of wrinkles, mild to moderate inflammatory acne	Treatment of wrinkles, mild to moderate inflammatory acne
Wavelengths	605nm amber, 630nm red, 660nm red, 880nm infrared, 415nm blue	605nm, 630nm, 660nm, 880nm
Irradiance source	LED	LED
Treatment Area	415 cm²	415 cm²
Treatment Time	3 minutes per treatment daily	3 minutes per treatment daily
Type/Class	OTC	OTC
Output (mW/cm²)	Similar to predicate devices	Not specified, but implied similar
Treatment Duration	Similar to predicate devices (180 seconds)	Similar to predicate devices (180 seconds)

The document states: "The dpl® IIa Panel system has the same intended uses, with similar technological characteristics as predicate devices. The system performs as intended and does not raise any new safety or effectiveness issues." This implies that the 'acceptance criteria' for substantial equivalence are met by demonstrating these similarities and conforming to safety standards, rather than proving clinical efficacy.

Sample size used for the test set and the data provenance:
The document mentions a "Usability Study" with 16 participants. No other test set data for clinical efficacy is reported. The provenance of these participants (e.g., country of origin, retrospective/prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical efficacy test set with ground truth established by experts is described. The usability study involved participants using the device, but no expert assessment of clinical outcomes.
Adjudication method for the test set:
Not applicable, as no clinical efficacy test set requiring adjudication is described.
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:
Not applicable. This device is a light therapy panel, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a standalone light therapy device, not an algorithm. Its performance is inherent in its operation.
The type of ground truth used:
For the usability study, the "ground truth" was whether participants could "demonstrate the light sensitivity test" and "use the device successfully." This is a user performance metric, not a clinical ground truth like pathology or expert consensus on disease state.
The sample size for the training set:
Not applicable. The document describes a physical medical device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
Not applicable.

In summary, the provided FDA 510(k) submission focuses on demonstrating substantial equivalence of the dpl® IIa Panel to existing predicate devices based on shared intended use, similar technological characteristics, and compliance with safety standards. It does not present a clinical study with detailed acceptance criteria for efficacy or related performance data against a defined clinical ground truth. A usability study with 16 participants confirmed user interaction success but not clinical outcomes.

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.