(17 days)
The MIST Therapy System produces a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.
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The provided text is a 510(k) clearance letter from the FDA for a device called the MIST® 360° Therapy System. This type of document primarily confirms that a device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements. It does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way a clinical study report or a technical summary would.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications from the provided text. This document is a regulatory communication, not a performance study summary.
§ 878.4410 Low energy ultrasound wound cleaner.
(a)
Identification. A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.