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Medical Protective Masks is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.

The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in black color.

The provided document (K223686) is a 510(k) Premarket Notification for Medical Protective Masks. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing and material comparisons.

It is crucial to understand that this document describes the regulatory acceptance of a medical mask device, NOT an AI/ML-driven device. Therefore, many of the requested fields regarding AI/ML-specific details (like training/test sets, ground truth establishment for AI, expert adjudication, MRMC studies, and standalone AI performance) are not applicable to this submission. The "study" referenced in the prompt (as proving the device meets acceptance criteria) refers to the non-clinical performance testing of the physical mask, not a clinical or AI-based study.

Here's the information extracted from the document relevant to the performance of the Medical Protective Masks:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provide non-sterile.

The subject device is a four-layer, single-use, flat-folded shape mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the filter (2 layers) is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and headband. The ear loops and headband are made of polyester. The nose clip is made of polypropylene and wire, user can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.

This document describes the acceptance criteria and the study results for the Guangdong Golden Leaves Technology Development Co., LTD's Medical Protective Mask (models 8862, 8862A, 8862B, 8862C, 8862D, 8862E), as presented in their 510(k) Summary (K223068).

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the ASTM F2100 standard for Medical Face Mask Materials. All models (Level 1, Level 2, and Level 3) of the Medical Protective Mask are stated to meet the performance requirements of all three levels.

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Medical Protective Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.

The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively.

The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in white color.

The provided text is a 510(k) summary for Medical Protective Masks, a Class II medical device. It does not describe an AI medical device. Therefore, it is not possible to answer the questions about acceptance criteria and study proving device performance for an AI device.

The document focuses on non-clinical performance testing of the medical masks to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The tests are for physical properties and biocompatibility of the mask, not for an AI algorithm's performance.

Here's an analysis of what is provided regarding acceptance criteria and performance, as it relates to the physical mask device, to clarify why it doesn't fit the AI-focused query:

1. Table of Acceptance Criteria and Reported Device Performance (for the physical mask):

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The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

The Medical Protective Mask is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a Iron core covered with polypropylene. The dimensions of each mask are length 162±5 mm and width 102±5 mm. The dimensions of nosepiece is length 90±10 mm and width 5±0.5 mm, and the ear loop is length 185±5 mm and width 5±0.5 mm. The mask is a single use, disposable device, provided non-sterile in white color.

This document is an FDA 510(k) premarket notification for a medical protective mask. It does not describe an AI medical device or an MRMC study. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance, especially those related to AI and human reader improvement, cannot be extracted from this document.

However, I can provide the acceptance criteria and reported performance for the physical and biological characteristics of the medical protective mask based on the provided text.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This table details the performance criteria for the Medical Protective Mask (Model: KF-A F02(N)) based on ASTM F2100 Level 2 standards.

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