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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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "No clinical studies were considered necessary and performed." This means there was no test set of patient data as would be used for an AI diagnostic device. The "tests" were conducted on the device itself (bench tests).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical studies or human expert ground truth establishment were performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical studies were performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the device's performance characteristics (e.g., wavelength, power), the "ground truth" was the physical measurement against the engineering specifications.
For safety and electromagnetic compatibility, the "ground truth" was compliance with established international standards (e.g., IEC 60601, ISO 10993).

8. The sample size for the training set
Not applicable. This is not an AI device that undergoes training on data.

9. How the ground truth for the training set was established
Not applicable. This is not an AI device that undergoes training on data.

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