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

1. Flexible silicone panel
1. Controller
1. Power supply and country specific adaptors
1. Adjustable straps (2)
  décoLITE is a home use wearable light emitting diode (LED) phototherapy device.
  The device consists of a flexible silicone panel (1) that contains red (630nm) and near infrared (830nm) light emitting diodes (LEDs), a controller (2) that contains a rechargeable lithium polymer batter, a power supply (3) for charging the battery, and two adjustable straps (4) that hold the panel in place during treatment.
  The LEDs produce red and near infrared (NIR) light in the visible spectrum (Red: 630nm ± 10nm, NIR: 830nm ± 10nm). The device works through a non-thermal mechanism called photobiomodulation. The LEDs produce light at an intensity of 30mW/cm² delivering 18J/cm² per treatment.
  The power supply is used to charge the lithium polymer battery in the décoLITE controller

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the décoLITE LED device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Clinical Effectiveness (Wrinkle Reduction)	Reduction in décolleté lines as measured by the validated Landau et al. (2016) scale.	The mean improvement after treatment was 0.9 points (from a mean baseline wrinkle severity of 2.5). 16 out of 19 subjects (84%) felt their wrinkles had improved.
Clinical Effectiveness (Overall Appearance)	Improvement in the overall appearance of the chest.	16 out of 19 subjects (84%) felt the overall appearance of their chest had improved.
Safety (Adverse Events)	No adverse events reported.	No adverse events were reported.
Electrical Safety	Compliance with relevant IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83, IEC 62133-2).	The device was tested and found to comply with all listed applicable standards.
Eye Safety	Compliance with photobiological safety standards.	The device was tested to and complies with IEC 62471:2006.
Thermal Safety	Acceptable skin and panel temperature changes during treatment.	During a 10-minute treatment, the change in skin temperature was +1°C (mean 35.5°C at end) and the panel surface increased by +1.1°C (mean 34.6°C at end). This implies the changes were within safe limits.
Light Characteristics	Verified output characteristics of the light.	Test results verified the output characteristics of the devices.
Usability/Human Factors	Users can complete tasks by following labeling without posing additional hazards.	All seventeen subjects were able to complete all tasks by following the device's labeling. Observations of tasks not completed precisely as specified were within normal use and did not pose additional hazards.

Study Details:

Sample size used for the test set and the data provenance:
- Clinical Performance Test Set Sample Size: 25 subjects were enrolled, 19 completed the full study treatment course. One subject's results were excluded due to unprotected sun exposure, resulting in 18 subjects effectively analyzed for efficacy.
- Usability/Human Factors Test Set Sample Size: 17 subjects.
- Data Provenance: The study appears to be prospective as it involved enrolling subjects, administering treatment, and then evaluating outcomes. The location of the study is not explicitly stated but implies a clinical setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document primarily describes a patient-reported outcome (subjects "felt their wrinkles had improved" and "felt the overall appearance of their chest had improved") and an objective assessment using a validated scale ("Landau et al. (2016)"). It does not explicitly state the number or qualifications of experts used for establishing the ground truth for the clinical effectiveness endpoints. The "mean baseline wrinkle severity was 2.5 and the mean improvement after treatment was 0.9 points" suggests an objective assessment, likely by a trained clinician or rater using the Landau scale. However, the exact number and qualifications of these raters are not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the clinical effectiveness endpoints. The assessment using the Landau et al. scale likely involved a single or multiple trained raters, but whether consensus or adjudication was used is not specified.
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 treatment, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical performance testing assesses the device's standalone effectiveness in reducing wrinkles when used by subjects at home. There is no human-in-the-loop component beyond the subject using the device as instructed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical performance study, the primary effectiveness endpoint was measured using a validated scale developed by Landau et al. (2016), which represents an objective clinical assessment tool. Additionally, patient-reported outcomes (subjects feeling improvement) were used. Safety was assessed by reporting adverse events.
The sample size for the training set:
- The document does not describe a separate "training set" in the context of an algorithm or machine learning model. The clinical study described is a performance study for the device itself, not for training a model.
How the ground truth for the training set was established:
- As there is no mention of a "training set" for an algorithm, this question is not applicable based on the provided text.

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.