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The Q-Swithched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for for General Dermatology, Dermatologic and General Surgical Procedures as follows:

1064nm:

• Tattoo removal
  • dark ink: blue and black
• Treatment of Benign Pigmented Lesions
  • Nevus of ota

532nm:

• Tattoo removal
  • Light ink: red, sky blue and green.
• Treatment of benign vascular lesions
  • Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi.
• Treatment of benign pigmented lesions
  • Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

Nd:YAG laser is a type of solid laser that is stimulated through Yttrium Aluminum Garnet (YAG Crystal) doped with a very small amount of Neodymium (Nd). Nd:YAG laser can generate pulsed or continuous laser, emitting laser with specific wavelength (usually 532nm or 1064nm). The principle of Nd:YAG laser product is that electrons in atoms can absorb energy and change from a lower energy level to higher energy level, then these electrons fall back to the lower energy level, releasing energy in the form of photons. Compared with ordinary light source, laser is monochromatic, directional and brighter.

Q-Switched Nd:YAG Laser is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel.

Machine System
Q-Switched Nd:YAG Laser (hereinafter referred to as "Machine") consists of machine main body (including Laser Device, Transmission and Target Indicating Device, Laser Power Supply and Control System, Safety Protection System, Cooling System, Power Supply System, Control System), 7-Joint Laser Arm, Vari-Focusing Handpiece, Foot Switch, Laser Protective Glasses, Power Cable, Support Bar (A Group of Support Bar and 2 Support Clamps), Casters and Attached Machine Accessories, etc. As shown by Figure 1, the machine shell is ABS shell, its accessories are aluminum alloy parts.

The provided FDA 510(k) clearance letter and summary for the Q-Switched Nd:YAG Laser (SHE-LSP101-1) does not describe acceptance criteria, nor does it detail a study that proves the device meets specific performance criteria related to clinical outcomes or diagnostic accuracy.

The summary focuses on non-clinical tests to verify that the device meets safety and performance standards for laser equipment, and that its technological characteristics are similar to predicate devices. It explicitly states, "Clinical study is not applicable." This indicates that the regulatory pathway for this device did not require a study demonstrating its effectiveness or diagnostic performance against defined acceptance criteria in a clinical setting.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or cannot be extracted from the provided text.

Here's the information that can be derived from the document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Engineering Specifications)

Since no clinical acceptance criteria or performance against such criteria are explicitly stated in the document, the "performance" presented here relates to the engineering specifications and safety standards adherence.

Study Details (Non-Clinical)

1. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical tests (engineering and safety standards adherence), not a test set of data for clinical performance or AI evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established from experts for performance evaluation.

3. Adjudication method for the test set: Not applicable. No test set for clinical performance.

4. 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 device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests was adherence to established international safety and performance standards for medical electrical equipment and laser products (e.g., IEC, ISO standards) and verification of its stated engineering specifications (wavelength, energy, spot size). There is no clinical "ground truth" discussed.

7. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The "study" refers to a series of non-clinical tests conducted to verify that the Q-Switched Nd:YAG Laser (SHE-LSP101-1) met its design specifications and complied with relevant international safety and performance standards for medical devices and lasers. These tests confirmed parameters such as laser peak wavelength, spot size, laser pulse energy, and maximum fluence, finding them to be within the specified ranges. Additionally, the device demonstrated compliance with a comprehensive set of standards, including:

• Electrical Safety: IEC 60601-1 (general requirements for basic safety and essential performance).
• Electromagnetic Compatibility (EMC): IEC 60601-1-2 and IEC/TR 60601-4-2.
• Laser Specific Safety: IEC 60601-2-22 (for surgical, cosmetic, therapeutic, and diagnostic laser equipment) and IEC 60825-1 (safety of laser products).
• Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and delayed-type hypersensitivity), and ISO 10993-23 (irritation).

The conclusion of these non-clinical tests was that the device is substantially equivalent to its predicate devices based on these performance and validation studies. The document explicitly states that a "Clinical study is not applicable," indicating that clinical efficacy or diagnostic accuracy studies were not required for this 510(k) clearance.

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