(161 days)
The Baxter Emergency Relief TM System consists of color-coded mini first aid kits. Each kit is intended to be used as a basic first aid treatment for various emergency situations, while seeking further professional medical assistance.
The Baxter Emergency Relief ™ System is designed as one large unit which houses various first aid kits Each mini kit contains various individual components traditionally used for first aid treatment. Each individual component is a finished good with an established regulatory path where applicable. All components are purchased as finished goods and packaged in the appropriate mini kit, including direction for use inserts. All direction for use inserts correspond to the instruction manual accompanying the system.
The provided text does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria. The document is a summary of safety and effectiveness for the Baxter Emergency Relief™ Kit System, detailing its components, classification, intended use, and substantial equivalence to predicate devices. It explicitly states: "Testing of the system was deemed not applicable as all regulated devices has an established regulatory path and is obtained in finished good form." This indicates that no specific performance study was conducted for the overall kit system as its components are already approved finished goods.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
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