(85 days)
Red light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Mixed light: Treatment of mild to moderate inflammatory acne.
The LED Light Therapy Machine, Models: G1, G3, G4, G6, is an LED phototherapy device for over-the-counter (OTC) use. The device package includes the LED Light Therapy Machine, an electrical adaptor to power the device, eye safety goggles, and a user manual. The device will automatically stop the treatment after a preset time. The device contains LEDs that emit light at 460 nm (blue), 620 nm (red), and/or 850 nm (infrared). The device can emit blue light only, red light only, infrared only, or blue light plus infrared light simultaneously.
I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification does not contain information about the acceptance criteria and study proving the device meets those criteria for software or AI/ML components.
The document states that the device is an "LED Light Therapy Machine" and details comparisons to a predicate device, focusing on electrical safety, biocompatibility, and usability testing. It explicitly mentions:
- "Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" This indicates that software is present, but it does not provide details on acceptance criteria or performance studies specific to AI/ML or diagnostic capabilities. The software concern level is rated "moderate," implying it's likely for device control rather than complex analytical functions requiring the extensive validation described in your prompt.
- "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." This explicitly states that clinical performance studies were not performed, which would be essential for demonstrating the acceptance criteria and performance of an AI/ML diagnostic or predictive device.
Therefore, I cannot populate the requested table and information points as the provided document does not contain the necessary data regarding acceptance criteria, performance metrics, sample sizes, expert ground truthing, adjudication methods, or MRMC studies for an AI/ML device. The device described appears to be a physical medical device (LED light therapy machine) with embedded software for control, not an AI/ML-driven diagnostic or treatment planning system that would typically require the types of studies you are asking about.
§ 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.