(99 days)
The MedCare Tracheostomy Care Tray is a single patient, single use, disposable device which is intended to be used for the administration of tracheostomy care.
The Medcare Tracheostomy Care Tray is intended to provide the components necessary for the care and cleaning of tracheostomy tubes and their insertion sites. The procedure of tracheostomy care includes wound care of the stoma, oral/nasal/pharyngeal/tracheal suctioning, and tracheostomy tube or inner cannula cleaning or inner cannula replacement (in the case of a disposable inner cannula (D.I.C.) system). The kits are provided sterile, disposable, and for single patient use.
The provided text describes a medical device, a Tracheostomy Care Tray, and its intended use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies as requested in your prompt.
Therefore, I cannot populate the table or answer the specific questions about device performance and studies based on the provided input. The text is a 510(k) summary focusing on the device's description, intended use, and comparison to predicate devices, but it lacks the detailed performance study information you are looking for.
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