(60 days)
The PICOCAREMAJESTY is indicated for the following at the specified wavelength:
· 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I - VI) to treat the following tattoo colors: black,brown, green, blue and purple.
· 532 nm: Removal of tattoos for Fitzpatrick skin types I · III to treat the following tattoo colors: red, yellow and orange.
· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 1064mm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
For treatment, the user can select the appropriate fluence value. (The treatmented is provided in the user Manual) The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased / decreased by 0.1 J/cm2.
The selectable fluence values are 0.2 to 10.0 J/cm2 at 1064nm and 0.1 to 2.5 J/cm2 at 532nm
The provided text is a 510(k) summary for the WON TECH Co., Ltd. Picosecond Nd:YAG Laser (PICOCAREMAJESTY). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a novel device, especially not data related to complex AI algorithms or diagnostic accuracy studies.
Therefore, many of the specific details requested in your prompt, particularly those related to AI algorithm performance, human-in-the-loop studies, ground truth establishment, and training/test set sample sizes, are not present in this document. The device in question is a laser for tattoo and pigmented lesion removal, which typically undergoes performance testing based on physical parameters, and electrical/software safety, rather than diagnostic accuracy studies with expert readers.
However, I can extract information related to what is available in the document:
Acceptance Criteria and Device Performance (Based on provided documentation's summary of testing):
The document primarily relies on comparisons to predicate devices and adherence to established safety and performance standards for laser surgical instruments. It doesn't present "acceptance criteria" in the sense of a statistical threshold for diagnostic accuracy for a new AI algorithm, but rather lists the device's technical specifications and verifies compliance with recognized standards.
| Acceptance Criteria (from Non-Clinical Tests) | Reported Device Performance (from "Performance Testing") |
|---|---|
| Electrical Safety & EMC Compliance: | Complies with: |
| - ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 | - Met basic safety and essential performance requirements. |
| - ANSI AAMI IEC 60601-1-2:2014 | - Met electromagnetic compatibility requirements. |
| - IEC 60601-1-6 Edition 3.1 2013 | - Met usability requirements. |
| - IEC 60601-2-22 Edition 3.1 2012-10 | - Met specific requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment. |
| - IEC 60825-1:2014 (Third Edition) | - Met laser product classification and safety requirements. |
| Software Validation: | |
| - Moderate level of concern software verified and validated. | - Software designed and developed according to a software development process and was verified and validated. |
| Biocompatibility: | |
| - Handpiece material (Aluminium Powder) biocompatible for intact skin, limited contact ( |
§ 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.