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To provide surface cooling effect during cutaneous laser surgery to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to possibly reduce pain associated with laser treatment.

The CoolSpot™ is essentially a "heat sink" which works by utilizing the latent heat of fusion properties of water and the thermal conductivity of copper and sapphire. The device design consists of a handpiece and a removable sealed reservoir of water that is frozen prior to use. The CoolSpot™ handpiece will house the cool tip and the laser delivery device during use. The cool tips will be stored in a freezer when not in use. A storage rack will be provided to hold up to 4 cool tips. The "active component", the cool tip, consists of a sealed tube filled with water that has a sapphire window affixed to its distal end. The tube is made of copper, which is gold plated and coated in plastic. The CoolSpot™ handpiece is designed so a laser delivery device is positioned such that the treatment beam passes through a sapphire window, which is cooled by virtue of its contact with the tubing and ice/water reservoir. The sapphire window will be in physical contact with the target treatment area during active use. The primary purpose of the window is to provide a heat sink in contact with the skin, which is at a lower temperature than the average skin surface temperature. The sapphire window will initially cool the skin and during laser activation, will absorb a portion of the heat generated by the selective absorption of the laser energy by the skin.

The provided text is a 510(k) summary for the Laserscope CoolSpot™ device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, or the methodologies for establishing ground truth, sample sizes, or multi-reader studies.

Therefore, I cannot populate the requested table or answer the specific questions regarding acceptance criteria and study details.

The document only states the following relevant information:

• Substantial Equivalence: The primary "proof" for clearance is that the Laserscope CoolSpot™ is deemed "substantially equivalent" to the Cool Laser Optics device and to Cold Packs. This means the FDA determined it has the same intended use, materials, and method of operation, and comparable risks and benefits.
• Performance Standards: The Laserscope EL Surgical Laser System and Accessories (with which the CoolSpot™ would be used) conforms with federal regulations and performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. This refers to the laser system itself, not the CoolSpot™ accessory.

Without a detailed performance study described in the provided text, I cannot extract the specific information requested in your prompt.

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