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The Safe Life B130 and B150 N95 Respirators and Surgical Masks are single-use disposable devices intended to protect healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. These respirators/surgical masks may be used during medical, surgical and dental procedures, and may also be used as isolation masks.

The Safe Life B130 and B150 N95 Respirators and Surgical Masks are single-use disposable devices.

This document is a 510(k) clearance letter from the FDA for a medical device: "Safe Life N95 Respirator and Surgical Mask, Models B130 and B150".

The provided text does not contain any information about acceptance criteria or the study that proves the device meets those criteria.

Instead, it's a regulatory letter confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses general controls, regulations, and reporting requirements, but not specific performance testing data.

Therefore, I cannot fulfill your request for the table of acceptance criteria, study details, sample sizes, ground truth information, or MRMC study results because this information is not present in the provided document.

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