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The Juniper Cooling Device XTRA is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Juniper Cooling Device XTRA can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and / or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite.

The Juniper Medical Coupling Gel facilitates thermal contact of the Juniper Cooling Device XTRA with a patient's skin by mitigating minor variances in device-to-skin contact.

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The provided text does NOT describe acceptance criteria for a device, nor does it detail a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the Juniper Cooling Device XTRA, which is a premarket notification to the FDA for a medical device. The core purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its performance against specific acceptance criteria through a clinical study.

Therefore, I cannot provide the requested information from the provided text. The document focuses on:

• Device Identification: Trade name, common name, classification, product codes.
• Predicate Device: Explaining which existing devices the new device is substantially equivalent to.
• Intended Use/Indications for Use: What the device is meant to do (skin cooling, localized thermal therapy, massage).
• Regulatory Clearance: The FDA's letter granting clearance based on substantial equivalence.

There is no mention of a study involving sample sizes, experts, ground truth, or any specific performance metrics (like sensitivity, specificity, accuracy) that would be typically found in a study designed to meet acceptance criteria for device performance.

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