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This mask is intended to be worn to protect both the patient and healthcare personnel fromtransfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

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This document is a 510(k) premarket notification letter from the FDA regarding a surgical mask (Amerishield Surgical Mask). It is a regulatory clearance document and does not contain information about software or AI/ML-based medical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as these concepts do not apply to the provided text.

The document discusses:

• The device name: Amerishield Surgical Mask
• Regulation Number: 21 CFR 878.4040
• Regulation Name: Surgical apparel
• Regulatory Class: Class II
• Product Code: FXX
• Indications for Use: "This mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile."

If you have a document pertaining to an AI/ML medical device, please provide that for analysis.

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This mask is intended to be worn to protect both the patient and healthcare personnel fromtransfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "AirMax Procedure Mask." This document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to a predicate device, and outlines the general controls and regulations applicable to such a device.

Crucially, the document does not contain information about acceptance criteria, specific device performance metrics (other than general indications for use), details of a study that proves the device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request for this information based on the provided text. The document is administrative and regulatory in nature, not a technical report detailing performance study results.

Ask a specific question about this device