(184 days)
The PICOCAREMAJESTY Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the PICOCAREMAJESTY 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)
532nm
The 532nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 10641m or 532nm at short durations. The device system consists of a main unit, an articulated ann, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated am 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 energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased by 0.1 J/cm².
The selectable fluence values are 0.2 to 16.0 J/cm². at 1064nm and 0.1 to 7.96 J/cm² at 532nm
The provided document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for a laser system called PICOCAREMAJESTY. This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study of the device against specific acceptance criteria for a new AI/medical device.
Therefore, the information required to populate a table of acceptance criteria and reported device performance for an AI-based medical device study (as implied by questions about sample size, ground truth, expert adjudication, MRMC studies, etc.) is not present in this document.
The document describes a physical laser device, not an AI software. The "software validation" section refers to the device's internal control software, not a diagnostic or AI algorithm.
However, I can extract information related to the device's specifications and performance tests that were conducted to ensure its physical operation aligns with its intended use and safety standards. This is distinct from a performance study for an AI diagnostic device.
Here's how to address the questions based on the provided document, acknowledging its limitations regarding AI-related performance studies:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the context of an AI-driven performance study (e.g., sensitivity, specificity, AUC). Instead, it provides performance specifications for the laser device itself and states that bench tests (non-clinical) were conducted to verify these.
| Characteristic | Specified Performance (Acceptance Criteria) | Reported Device Performance (Verified by Bench Tests) |
|---|---|---|
| Laser Wavelength | 1064nm ± 10%, 532nm ± 10% | Met specifications |
| Laser Output Power | 1064nm mode: (30 to 500)mJ | Met specifications |
| 532nm mode: (20 to 250)mJ | Met specifications | |
| Pulse Width | 1064nm mode: 300-400 ps | Met specifications |
| 532nm mode: 300-400 ps | Met specifications | |
| Pulse Repetition Rate | 1064nm mode: 1-10Hz | Met specifications |
| 532nm mode: 1-10Hz | Met specifications | |
| Radiation Diameter | 1064nm mode: (2 to 10mm) step: 1mm | Met specifications |
| 532nm mode: (2 to 10mm) step: 1mm | Met specifications | |
| Electrical Safety | Compliance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Complies (Verified) |
| Electromagnetic Compatibility | Compliance with ANSI AAMI IEC 60601-1-2:2014 & IEC 60601-1-6 Edition 3.1 2013 | Complies (Verified) |
| Biocompatibility | Compliant with ISO 10993-1 for Limited ( |
§ 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.