Search Results

This device is used as a physical barrier for mouth to mouth resuscitation. The use of this device does not guarantee complete protection from disease transmission.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "CPR Face Shield" (K192285) does not contain any information about a study proving the device meets acceptance criteria.

The document is a standard FDA clearance letter, which confirms that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory matters such as registration, listing, manufacturing practices, and adverse event reporting.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

The document details:

• The device name: CPR Face Shield
• Regulation Number: 21 CFR 868.5870 (Nonrebreathing Valve)
• Regulatory Class: Class II
• Product Code: CBP
• Indications for Use: "This device is used as a physical barrier for mouth to mouth resuscitation. The use of this device does not guarantee complete protection from disease transmission."

None of these sections imply or describe performance studies with acceptance criteria as one would expect for an AI/software as a medical device (SaMD) or other complex diagnostic/therapeutic device. For a simple physical barrier like a CPR face shield, the "acceptance criteria" for FDA clearance primarily revolve around substantial equivalence to existing devices, safety considerations inherent to its material and design, and its stated intended use. A formal "study" with the characteristics you outlined (test sets, experts, MRMC, etc.) would not typically be required or relevant for this type of device.

Ask a specific question about this device