(264 days)
The PICO LEGEND Nd: Y AG Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
-The 1064nm wavelength of the PICO LEGEND Nd: Y AG Laser System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
-The 532mm wavelength of the PICO LEGEND Nd:YAG Laser System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
This device comprises the main body, including the optics laser generator, power supply, cooling system, operation panel, articulated arm, handpiece, foot-switch, protective goggles, power supply cord, etc. Applying a high voltage to the laser generator generates 1064nm and 532nm laser emission wavelengths. The maximum output is 500mJ.
The optical laser generator (optics), power supply, chiller, touch LCD panel, switching mode power supply, main control board, air pump, etc., are operated by a microprocessor.
The Optical Laser Generator (Optics) is comprised of Nd: YAG Rod, which is the solid laser medium, Flash lamp for optical generation, various Reflector for optical transmission, etc., and permits high voltage in flash lamp connected with power supply and operates to generate laser. After turning on the device, once the Wavelength, frequency, Frequency, Spot Size, etc., have been set, press the Foot Switch in the READY state; the laser energy will be produced and transferred through the Articulated Arm and handpiece.
The provided document is a 510(k) Premarket Notification for the PICO LEGEND Nd:YAG Laser System. This document does not describe a study involving an AI/Machine Learning device. Instead, it focuses on demonstrating substantial equivalence of a laser medical device to a predicate device.
Therefore, the specific information requested in the prompt regarding AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI, is not present in this document.
The document states:
- "9. Clinical Testing: No clinical testing provided." This explicitly indicates that no human subject studies were conducted to prove the device's efficacy or safety.
- The performance data section (Section 8) describes non-clinical testing related to electrical safety, EMC, usability, laser safety, and biocompatibility, as well as bench testing to confirm energy output specifications. It also mentions "Software Verification and Validation Testing" but this refers to traditional software engineering V&V, not AI/ML model performance evaluation against clinical ground truth.
In summary, this document is irrelevant to the request for information on an AI/ML device's acceptance criteria and performance study. The device is a laser system, and its clearance is based on substantial equivalence to a predicate device and compliance with applicable non-clinical performance standards.
§ 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.