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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.

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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.

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