Search Results

This product is intended to be worn by operating room personnel to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a Protection Plus Earloop Procedure Mask. This document is a regulatory approval for a medical device and does not contain information about acceptance criteria or a study proving device performance in the way you've requested (e.g., for an AI/algorithm).

The questions you've asked are typically relevant to the validation of AI-powered medical devices, specifically regarding their performance metrics, ground truth establishment, and clinical study designs.

Since the provided text is for a physical medical mask and not an AI device, I cannot extract the information you've requested. The document confirms that the mask is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval, not a separate performance study with associated metrics as you've outlined.

Therefore, I cannot populate the table or answer the specific numbered questions based on the input provided.

Ask a specific question about this device