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Opportunity Inc.'s Tracheostomy Care Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing tracheostomy procedures.

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This document is a 510(k) clearance letter from the FDA for several medical kits, including the "Opportunity Tracheostomy Care Kit." It primarily addresses regulatory aspects and does not contain information about the acceptance criteria, study details, or performance of a specific device in the context of a clinical or performance study.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include studies related to the device's efficacy or performance characteristics with specific metrics.

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