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The Q-Switched Nd: Y AG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, incision, ablation, vaporization of soft tissue for general dermatology as follows:

532nm wavelength (nominal delivered energy of 585nm and 650mm with optional dye handpiece):

• Removal of light ink (red, sky blue, green, purple, and orange) tattoo
• Treatment of benign vascular lesions including, but not limited to: telangiectasias,
• Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses
• Treatment of Post Inflammatory Hyper-Pigmentation

1064nm wavelength:

• Removal dark ink (black, blue and brown) tattoo
• Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma.
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.

The Q-Switched Nd: YAG Laser System is based on the Q-Switch Nd: YAG and frequency-double Nd:YAG laser technology. The system is composed of laser generator, articulated arm, laser power supply, cooling system, display and control system,foot switch and others accessories.

The Q-Switched Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that concert the 532nm wavelength to 585nm and 650nm.

The Q-Switched Nd: YAG Laser System includes two models: HS-290K and HS-290EK.

I apologize, but the provided text from the FDA 510(k) summary for the Q-Switched Nd: YAG Laser System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software-based diagnostic AI.

Here's why and what the document does discuss:

• Device Type: The document describes a Q-Switched Nd: YAG Laser System, which is a physical laser device used for various dermatological and surgical applications (tattoo removal, pigmented lesions, etc.). It is not an artificial intelligence (AI) software or diagnostic imaging device.
• "Acceptance Criteria" in this context: For a physical medical device like a laser, "acceptance criteria" primarily refer to meeting technical specifications (e.g., laser power output accuracy, wavelength precision, pulse duration, electrical safety standards, electromagnetic compatibility). These are shown in the "VII Non-Clinical Testing" section by compliance with IEC standards.
• No AI Study: Since this is not an AI/software device, there is no discussion of:
  • A table of acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC).
  • Sample sizes for test sets or data provenance for AI validation.
  • Number of experts, qualifications, or adjudication methods for AI ground truth.
  • MRMC studies for human reader improvement with AI assistance.
  • Standalone algorithm performance.
  • Ground truth types like pathology or outcomes for diagnostic AI.
  • Training set details for an AI model.

The document explicitly states under "VIII Clinical Testing": "It is not applicable." This means that for the purposes of this 510(k) submission and establishing substantial equivalence for this laser device, a formal clinical study (which would be where you'd typically find performance data against clinical endpoints or, in the case of diagnostic AI, against expert ground truth) was not required by the FDA. The submission relies on non-clinical testing showing compliance with recognized standards and a comparison of technological characteristics to a predicate device.

Therefore, I cannot extract the information you requested based on the provided text. The questions are highly relevant for diagnostic AI medical devices, but the provided document describes a therapeutic laser device.

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