(128 days)
The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
The proposed device, RED Light Device is a battery operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots.
The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C. charging adapter.
It is a hand held light emitting diode (LED) device for the treatment of periorbital wrinkles designed for home-use.
The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.
The provided text is a 510(k) summary for the "RED Light Device," seeking FDA clearance based on substantial equivalence to a predicate device. It does not describe a clinical study designed to prove the device meets specific acceptance criteria in the way an AI/ML device would be evaluated. Instead, it focuses on non-clinical tests to demonstrate safety and performance equivalence to a previously cleared device.
Therefore, many of the requested categories for AI/ML device evaluation (like acceptance criteria for performance metrics, ground truth establishment for a test set, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an algorithm) are not applicable to this submission, as it's for a light therapy device.
Here's a breakdown of the information that is available, reframed to address your request where possible, and clearly indicating what is not present in the document given its nature:
1. A table of acceptance criteria and the reported device performance
The document frames "acceptance criteria" and "performance" in terms of equivalence to the predicate device and compliance with established safety standards, rather than performance against a clinical efficacy target metric.
| Acceptance Criteria Category | Reported Device Performance / Compliance |
|---|---|
| Product Code | OHS (Substantially Equivalent to Predicate) |
| Regulation No. | 21 CFR 878.4810 (Substantially Equivalent to Predicate) |
| Class | 2 (Substantially Equivalent to Predicate) |
| OTC use | Yes (Substantially Equivalent to Predicate) |
| Indication for Use | To emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles (Substantially Equivalent to Predicate) |
| Handheld | Yes (Substantially Equivalent to Predicate) |
| Contacting Materials | ABS & Stainless Steel (Substantially Equivalent to Predicate) |
| Measurement Wavelength | Red: 633 ±5nm; Infrared: 830 ±5nm (Substantially Equivalent to Predicate) |
| Light Source | Light Emitting Diode (LED) (Substantially Equivalent to Predicate) |
| Waveform | Constant (Substantially Equivalent to Predicate) |
| Energy Source | 25 LEDs over 17 cm² (Substantially Equivalent to Predicate) |
| Power Density | 125 mW/cm² (70 mW/cm² (633 nm); 55 mW/cm² (830 nm)) (Substantially Equivalent to Predicate) |
| Power Supply | Adaptor: 100~240V AC 50/60Hz; Lithium battery: 2x3.7V (Substantially Equivalent to Predicate) |
| Initial Treatment Course | For the first month (4 weeks), treatment should be performed 3 times a week for 15-20 minutes each time (5-7 minutes on each treatment zone). (Substantially Equivalent to Predicate) |
| Electrical Safety | Complies with IEC 60601-1, IEC 60601-1-11, IEC 62471, IEC 60601-2-57 (Substantially Equivalent to Predicate for those shared, and additional compliance for proposed device) |
| EMC | Complies with IEC 60601-1-2 (Substantially Equivalent to Predicate) |
| Biocompatibility | Complies with ISO 10993-1 (Substantially Equivalent to Predicate). Specifically, ISO 10993-5 (In Vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) were tested. |
| Usability/Label Comprehension | 100% of 35 participants correctly self-selected, demonstrated setup, light sensitivity test, operation, and cleaning. 95% correctly answered each questionnaire question. (This acts as a performance metric for user understanding and safe use). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For the Usability/Label Comprehension Study, the sample size was 35 participants.
- Data Provenance: The document does not specify the country of origin for the usability study participants. It's a prospective study for usability.
- For demonstrating technical compliance (e.g., electrical safety, EMC, biocompatibility): These tests are typically performed on samples of the device itself by accredited labs. The "sample size" here refers to the number of devices tested, which isn't specified but generally follows standard testing protocols for device certification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable in the context of clinical efficacy experts determining ground truth for a diagnostic AI.
- For the Usability/Label Comprehension study, the "ground truth" was whether participants could correctly perform tasks and answer questions based on the instructions, which was assessed directly by the study design, not by external experts establishing a clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as there is no clinical test set requiring adjudication for ground truth.
- For the usability study, the performance criteria (e.g., 100% correctly demonstrated setup) are objective and do not require expert adjudication in the manner of medical image interpretation.
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 a direct-to-consumer light therapy device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The "RED Light Device" is a physical light therapy device, not an algorithm. Its performance is inherent in its physical output and user interaction, not in standalone algorithmic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical efficacy as no clinical study was conducted.
- For Usability: The "ground truth" was successful completion of prescribed tasks and correct answers to questionnaire items as defined by the study protocol related to understanding device operation and safety.
8. The sample size for the training set
- Not applicable. This device does not use machine learning, therefore there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for a machine learning algorithm, ground truth establishment for a training set is irrelevant.
§ 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.