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The Medical 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 masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.

The Medical Masks are single use, three-layer, flat masks with ear loops/straps and nose clamp. The Medical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt blown polvpropylene filter.

The model of proposed device, Ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.

The model of proposed device. Tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.

The nose clamp contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of metal core plastic.

The proposed devices are single use, disposable device, provided in both non-sterile and sterile forms.

The provided text is a 510(k) summary for a Medical Mask (K210020). It describes the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically focusing on non-clinical performance standards for medical face masks.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for this medical mask are based on established performance standards for surgical masks, primarily ASTM F2100-19 (Standard Specification For Performance of Materials used in Medical Face Masks) for Level 3 categorization, and other supporting standards for specific properties.

Table of Acceptance Criteria and Reported Device Performance:

3. Adjudication Method for the Test Set:

   • Not applicable. Performance testing of physical products against defined standards does not involve an adjudication method in the same way clinical trials or image readings might. The results are quantitative measurements or pass/fail determinations based on predefined criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was not done. The document explicitly states: "No clinical tests were performed." MRMC studies are typically used for diagnostic devices involving human interpretation of medical data (e.g., radiology AI tools). This device is a medical mask, which is evaluated based on its physical and biological barrier properties.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is slightly misapplied to a medical mask. If interpreted as "was the device's performance evaluated independently of human use for its intended function (e.g., filtration efficiency tested on a machine)?" then yes. The performance metrics like BFE, PFE, fluid resistance, flammability, differential pressure, and biocompatibility are all measured in a standalone laboratory setting, independent of human interaction during the test itself. The mask's performance is the algorithm in this context – its material composition and design dictate its performance.

6. The Type of Ground Truth Used:

   • The "ground truth" for this device's performance is based on pre-defined, internationally recognized technical standards and specifications. These standards (e.g., ASTM F2100-19 for medical face masks) lay out the specific performance thresholds (e.g., >98% BFE, >98% PFE,

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The Medical 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 masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Medical Masks are single use, three-layer, flat –folded masks with ear loops and nose clamp. The Medical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Medical Masks will be provided in blue. The medical masks are sold non-sterile and are intended to be single use, disposable devices.

The provided text describes the acceptance criteria and the study conducted for the Medical Mask (Model L1171801) by Zhende Medical Co., Ltd. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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