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The PMW01 Procedure Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

PMW01 Procedure Mask Level 1

The provided text is a U.S. FDA 510(k) clearance letter for the PMW01 Procedure Mask Level 1. This document confirms the device's substantial equivalence to previously marketed devices. However, this type of document does not contain information about acceptance criteria for device performance, the results of studies proving these criteria are met, sample sizes, expert qualifications, or ground truth establishment.

Instead, the FDA 510(k) clearance process primarily evaluates whether a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. For medical masks, this typically involves testing against recognized industry standards such as ASTM F2100 to show performance levels (e.g., Level 1, 2, or 3).

Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth. These details would typically be found in a separate submission document or a summary of safety and effectiveness, which are not part of the clearance letter itself.

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The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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

This document is a 510(k) clearance letter from the FDA for a medical device, specifically surgical and procedure masks. It does NOT contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device.

Therefore, I cannot extract the requested information like:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set and data provenance.
• Number of experts for ground truth and their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is primarily concerned with regulatory clearance for a physical product (masks) based on substantial equivalence to existing devices, not the evaluation of an AI algorithm's performance.

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