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The handPICO® Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for:
· Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
· Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

• · Treatment of acne scars in Fitzpatrick Skin Types II-V.
  · Treatment of wrinkles in Fitzpatrick Skin Types I-IV.

This 510(k) adds the handPICO® Fractional Laser Handpiece Tip, which is specifically designed for the ETHEREA MX and ZYE® LASERs manufactured by Vydence Medical Inc. The handPICO Fractional Handpiece Tip is a fractional optical element micro lens array that attaches to the handpiece. The producing 280 microbeams/cm2 and a total of 100 microbeams spaced 600 µm apart.

The provided text does not contain information about specific acceptance criteria, reported device performance metrics (numerical values for sensitivity, specificity, accuracy, etc.), or the details of a study that proves the device meets these criteria in the context of an AI/ML-driven medical device.

The document describes a 510(k) premarket notification for a HandPICO Fractional Laser Handpiece Tip, which is a hardware device, not an AI/ML software. The "Software verification and validation testing" mentioned refers to the software embedded within the medical device itself, likely for controlling the laser operation, and not a separate AI/ML component for analysis or diagnosis.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML study.

The document focuses on demonstrating substantial equivalence of the laser handpiece tip to predicate devices based on:

• Indications for Use Comparison: Showing similar indications for tattoo removal, benign pigmented lesion treatment, acne scar treatment, and wrinkle treatment.
• Technological Characteristics Comparison: Comparing aspects like laser source, wavelength, pulse width, repetition rate, spot size, and fluence, and explaining the clinical acceptability of minor differences.
• Clinical Testing Summary: A histological analysis on human participants to assess tissue changes and resolution.
• Non-Clinical Testing: Compliance with various electrical, safety, and risk management standards (e.g., IEC 60601-1, ISO 14971).
• Biocompatibility Testing: Ensuring materials in contact with patients are safe (Cytotoxicity, Sensitization, Irritation reactivity tests).
• Software Verification and Validation: For the embedded software controlling the device.

If this was an AI/ML device, the FDA submission would typically include a detailed clinical validation study with quantitative performance metrics (e.g., AUC, sensitivity, specificity) and a clear description of the ground truth generation process. This information is absent here.

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