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The Surgical face 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. This is a single-use, disposable device, provided non-sterile.

The Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use. The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.

The provided document is a 510(k) premarket notification for a Surgical Face Mask. It details the device's technical specifications and comparative performance against a predicate device, primarily through non-clinical testing. It does not describe a study involving an AI/Machine Learning device or associated clinical performance evaluation. Therefore, I cannot provide information on acceptance criteria and study data related to AI/Machine Learning algorithm performance, ground truth establishment, expert adjudication, or MRMC studies.

However, I can extract the acceptance criteria and performance data for the physical properties and biological safety of the surgical face masks as presented in the document.

1. A table of acceptance criteria and the reported device performance for physical properties and biocompatibility:

The document presents performance data for both Level 2 and Level 3 surgical face mask models, as per ASTM F2100-19 standards. The testing was conducted on samples from "3 non-consecutive lots."

Table of Acceptance Criteria and Reported Device Performance (Surgical Face Mask - Physical and Biocompatibility Testing)

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The 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 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, and provided as sterile.

Level 3 Surgical mask model (Ear-loop): XT10A1
Level 3 Surgical mask model (Tie-on): XT10B1

The surgical mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into three layers, the inner and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of polyethylene coated steel wire, the ear loops are made of polyester silk & polyurethane filament, and the ties are made of polypropylene.

The size specification of the surgical mask:

• Mask body for ear-loop type: 17.5cm×9.5cm & 14.5cm×9.5cm;
• Mask body for Tie-on type: 17.5cm×9.5cm

The provided text is a 510(k) summary for a surgical mask (K211454) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving human readers or AI assistance. Therefore, information related to AI performance, human reader improvement with AI, or MRMC studies is not available in this document.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical 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 surgical mask is a three-layer flat-pleated mask made of nonwoven polypropylene materials. The inner layer (white color) and the outer layer (blue color) are made of spunbonded polypropylene to provide comfort and breathability; the middle filtration layer is made of melt-blown polypropylene. The three layers are bonded together sonically along the four edges with the inner layer slightly folded over the outer layer along the long edges.

The mask is fitted to cover the wearer's nose and mouth with ear-loops. The ear-loops are made of knitted polyester/ elastane. They are welded to the mask. The materials do not contain natural rubber latex.

A malleable polyethylene laminated aluminum nosepiece is placed between the layers along the top edge of the mask for extra comfort and fit around the wearer's nose.

The surgical mask is intended to be a single-use disposable device, provided non-sterile.

The provided text is a 510(k) Summary for a Surgical Mask, specifically K210524 from Changzhou Holymed Products Co., Ltd. It details the device, its intended use, comparison to a predicate device, and performance testing to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the performance testing is summarized in Table 2: Non-Clinical Performance Testing Table on page 6.

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The Surgical 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.

The surgical mask is composed of three-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, white), filter middle layer (polypropylene melt-blown, white) and inner layer (spunbond polypropylene, white). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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