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The Candela Clearbeam Pulse Dye Laser is indicated for the following uses in:

General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, angioma, spider angioma, poikiloderma of Civatte and benign cutaneous lesion, such as warts, scars, striea and psoriasis. Treatment of periocular wrinkles.

Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology

Podiatry: Treatment of benign cutaneous lesion, such as warts.

The Clearbeam Pulse Dye laser is a 585 nm pulsed, flash lamp excited dye, medical laser, controlled by an embedded microprocessor, to be used for the treatment of psoriasis, telangiectasia, port wine stains, benign cutaneous lesions and other dermatologic applications. The laser system may be used with the Candela Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 5. 7 or 10 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.

The Candela Clearbeam Pulse Dye Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

The provided text is a 510(k) summary for the Candela Clearbeam Pulse Dye Laser System. This document outlines the device's description, claims of substantial equivalence to predicate devices, and regulatory approval. However, it does not contain information regarding an acceptance criteria study, reported device performance metrics in a clinical context, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The "Testing" section only mentions compliance with general laser performance standards and electrical safety standards, which are not related to clinical efficacy or an AI's performance. The "Summary of Substantial Equivalence" notes similarities in intended use, operating principles, and design aspects between the new device and predicate devices, which is the basis for its 510(k) clearance, not a study demonstrating clinical performance against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text does not describe an acceptance criteria study or the data provenance, ground truth, or expert involvement typically associated with such studies for AI/ML devices.

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