(252 days)
The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. The device is indicated for adults only.
The LED THERAPY DEVICE is a facemask-shaped device, which directly applies light onto the face skin surface and makes use of specific light spectral characteristics. The proposed device has total of 150 LEDs and operates in two modes. One mode emits blue light with wavelengths centered at 415nm ±5nm, and the other mode emits red light with wavelengths centered at 630nm ±5nm. The red light is intended for the treatment of wrinkles. The blue light is intended for the treatment of the mild to moderate inflammatory acne. The blue light mode has ten level energy output settings, 5mw/cm2-50mw/cm2. The red light mode has ten level energy output settings, 8mw/cm2-80mw/cm2. The user can change the treatment mode according to their own needs. The LED THERAPY DEVICE is powered via a plug-in power adapter.
The provided document is a 510(k) Summary for an LED Therapy Device. It does not describe an acceptance criteria table with reported device performance in the typical sense of a clinical or performance study for a diagnostic AI device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing for safety and usability.
However, I can extract information related to the device's "performance" in the context of its regulatory submission and translate usability study results into a format that approximates acceptance criteria and reported performance metrics.
Here's an attempt to structure the information based on your request, with the understanding that the "device performance" in this context primarily relates to usability and safety, not diagnostic accuracy:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "performance" is primarily assessed through usability and safety testing, as no clinical efficacy study was conducted for the 510(k) submission. The acceptance criteria are derived from the usability study's goals.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Usability: Questionnaire Score | |
| - Overall subject score ≥ 95% in understanding the device. | 100% overall subject score in understanding of the device. |
| - 100% of questions related to Risks, Warnings, Cautions, Precautions, and other important Instruction Manual data correctly answered. | 100% of each question relating to Risks, Warnings, Cautions, Precautions, and other important data from the Instruction Manual, correctly answered. |
| - Participant overall score ≥ 95% based on correct answers to questionnaire. | 100% participant overall score achieved, with 100% of each question correctly answered. |
| Usability: Operation Demonstration | |
| - Participant overall score ≥ 95% in demonstrating correct device operation. | 100% of participants were able to correctly demonstrate: |
- How to install the device.
- Perform the Light Sensitivity Test.
- Operate the device.
- Clean & disinfect the device.
An overall subject score of 100% was achieved. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Usability Test Set: 45 end-users.
- 15 participants with mild inflammatory acne.
- 15 participants with moderate inflammatory acne.
- 15 participants with periorbital wrinkles.
- Data Provenance: Prospective study conducted in America (AD Precision Health storefront and office, Carrollton, TX).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The usability study ground truth was based on participants' ability to understand and operate the device correctly, rather than on expert medical assessment of outcomes.
4. Adjudication Method for the Test Set
This information is not provided in the document. For the usability study, the "ground truth" (correctness of answers/demonstrations) would likely have been predefined by the study protocol, and scoring conducted against these predefined correct responses/actions. There's no indication of an adjudication panel.
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
No. A MRMC comparative effectiveness study was not done. This device is an LED therapy device, not an AI-powered diagnostic or assistive tool for human readers. No AI components are mentioned in the submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
N/A. This is an LED therapy device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the usability study was based on:
- Correct responses to a questionnaire: Assessing user comprehension of instructions, risks, warnings, etc.
- Successful demonstration of predefined operational tasks: Such as installation, light sensitivity test, operation, cleaning, and disinfection.
For the substantial equivalence determination, the ground truth was also established by comparing the device's technical specifications and safety standards compliance to those of legally marketed predicate devices.
8. The Sample Size for the Training Set
There is no training set in the context of an AI/ML algorithm, as this is a physical LED therapy device. The non-clinical tests (biocompatibility, electrical safety, EMC, photobiological safety) would have been performed on a sample of the manufactured devices, but this is not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set was Established
N/A, as there is no training set for an AI/ML algorithm. For the non-clinical tests, the ground truth was established by internationally recognized standards (e.g., ISO, IEC) against which the device's performance was measured.
§ 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.