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The Medical Diode Laser (Model: MZ-GK) is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: MZ-GK) is further indicated for laser assisted lipolysis.

The Medical Diode Laser (Model: MZ-K20) is indicated for:

• Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.
• Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux.

The Medical Diode Laser (Model: MZ-N75) is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.

The Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) incorporates a solid state diode as laser energy source for producing its therapeutic effects, it is designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 980nm and 1470nm respectively for MZ-GK, 1470nm for MZ-K20 and 1940nm for MZ-N75. The device also incorporates a red (650nm) or green(532nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, foot switch, power cord, and protective goggles. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via third-party optical fibers with SMA905 connectors and with single cores of 200μm, 300μm, 400μm, 600μm, 800μm and 1000μm diameter respectively.

The provided FDA 510(k) clearance letter is for a Medical Diode Laser and does not contain information about AI/ML device performance, acceptance criteria, or a comparative effectiveness study involving human readers and AI.

The document primarily focuses on demonstrating substantial equivalence of the new laser device to existing predicate devices based on technical specifications and safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1). It explicitly states "Clinical data: Not applicable" and details only non-clinical bench testing and software verification/validation for the laser's operational performance, not diagnostic or therapeutic accuracy in an AI context.

Therefore, I cannot provide the requested information as it is not present in the provided text. The questions asked are typically relevant for AI/ML-enabled medical devices that involve image analysis, diagnostic assistance, or other functions where performance metrics like sensitivity, specificity, accuracy, and human reader studies are crucial.

To answer your questions, I would need a different type of FDA clearance document, specifically one for an AI/ML-enabled medical device.

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