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The Medical 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 surgical 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(s), provided non-sterile.

The Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 2 and Level 3 based on ASTM F2100-19. The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask. This is a single use, disposable device(s), provided non-sterile.

The provided FDA 510(k) summary for the Azur Medical Company Inc. Medical Surgical Mask (K231719) details the acceptance criteria and study results for the device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Medical Surgical Mask with two types: Level 2 and Level 3, based on ASTM F2100-19.
The table below combines information from the "VII Comparison of technological characteristics with the predicate device" and "VIII Summary of Non-Clinical Tests" sections. Note that for some performance characteristics, the specific numerical results are given in comparison to the predicate, while for others, only "Pass" is stated against the acceptance criteria.

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Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

The Medical surgical mask is flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is provided non-sterile and is intended to be a single use, disposable device.

The document provided relates to a 510(k) premarket notification for a Biodegradable Medical surgical mask (K231155) and is primarily focused on demonstrating substantial equivalence to a predicate device (K201622) through non-clinical performance testing. It does not contain information about the performance of an AI/ML powered device, nor does it describe a study involving human readers or expert ground truth adjudication in the context of diagnostic accuracy.

Therefore, the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models is not applicable to this document.

The document reports on standard non-clinical performance tests for medical masks. Here is a table summarizing the acceptance criteria and results for these tests:

1. Table of acceptance criteria and the reported device performance:

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Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. The Medical 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.

Medical Surgical Mask includes 6 models, which are ZKM-U02 (Black), ZKM-U03 (Blue), ZKM-U04 (White), ZKM-U05 (Black), ZKM-U06 (Blue), ZKM-U07 (White). The Medical Surgical Mask is a non-sterile, single use, three-layer mask with ear loops and nose piece. These 6 models of Medical Surgical Mask share the same structure and they are manufactured with three layers, the outer and inner layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt spray fabric. The Medical Surgical Mask is held in place over the user's mouth and nose by two ear loops made of polyester textured yarn. The nose piece is made of polyethylene, which allows the users to adjust the nose piece according to the shape of the bridge of the nose.

The provided text describes the acceptance criteria and performance of a Medical Surgical Mask but does not involve an AI-powered device or a study comparing AI assistance with human readers. Therefore, the questions related to AI effects, training data, and expert adjudication are not applicable.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The device, "Medical Surgical Mask," was tested according to various standards (ASTM, EN, CFR, ISO). The results are categorized by Level 1 and Level 3 barrier requirements as per ASTM F2100.

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

The Medical Surgical Masks are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch. The inner layer and outer layer of the mask are made of non-woven fabric (polypropylene), the middle layer is made of melt-blown fabric (polypropylene). The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with polyamide and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped galvanized soft wire. The Medical Surgical Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

This document is a 510(k) premarket notification for a Medical Surgical Mask (Planar type). It focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA. The performance data presented is for the device itself, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML clinical studies are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Medical Surgical Mask, and its performance is evaluated against parameters specified in medical device standards such as ASTM F2100. The acceptance criteria and reported performance are for the physical properties and barrier effectiveness of the mask.

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Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

The medical surgical mask (model: Black mask, Level 3) is a flat pleated style mask with ear loops, and a nose piece design for fitting the mask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt-blown polypropylene. Ear loops are held to cover the users' mouth and nose by two polypropylene bands ultrasonically welded to the mask. The elastic ear loops are not made with natural rubber latex. The nose piece included in the mask is in the middle layer of the mask, to allow the user to fit the mask around their noses. The mask will be provided in black color, the colorant for the masks is Carbon black (CAS No.1333-86-4).

The subject device has 2 kinds of dimensions: 17.5 cm x 9.5 cm and 14.5 cm x 9.5 cm, and 2 kinds of protection performance: Level 1 and Level 3.

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

The requested information pertains to a medical surgical mask, which is a physical device, not an AI/ML powered device. Therefore, acceptance criteria and study details relevant to AI/ML powered devices are not applicable.

However, based on the provided document, I can extract the acceptance criteria and performance data for the physical medical surgical mask for Level 1 and Level 3 performance, as well as biocompatibility testing.

Here's the relevant information about the acceptance criteria and the study that proves the device meets these criteria, focusing on the available context for a physical medical surgical mask:

1. A table of acceptance criteria and the reported device performance

Medical Surgical Mask (Level 1)

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The MEDICAL 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 MEDICAL 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 subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.

The provided text describes the acceptance criteria and performance of a Medical Surgical Mask (Model: JM92, JM92B) based on non-clinical testing for FDA 510(k) clearance, not a study involving human readers or AI. Therefore, I cannot provide information on points 2, 3, 4, 5, 8, and 9 as they are not applicable to this type of device submission.

Here is the information from the document related to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical 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(s), provided sterile.

The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical 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(s), provided sterile.

The proposed device(s) are Blue color, and Flat Pleated type mask(s), utilizing Ear Loops to secure to the users head and a pliable Nose Piece for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene melt-blown fabric.

The Medical Surgical Masks-Sterile is held in place over the users' mouth and nose by two elastic ear loops affixed to the facemask. The elastic ear loops are made with nylon or spandex.

The nose piece contained in the proposed device(s) is contained within the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire.

The proposed device(s) are sold sterile and are intended to be single-use, disposable devices.

The provided document is a 510(k) Summary for a medical device, a "Disposable Medical Surgical Mask". It details the device's technical characteristics, performance, and biocompatibility compared to a predicate device, as well as the non-clinical tests performed to demonstrate substantial equivalence.

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

1. A table of acceptance criteria and the reported device performance

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Medical Surgical Mask is 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 as sterile.

The Medical Surgical Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Surgical Mask is manufactured with three layers, the inner and outer layers are made of 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 piece in the lavers of facemask is to allow the user to fit the facemask around their nose. which is made of Galvanized iron wire. The Medical Surgical Mask will be provided in blue. The Medical Surgical Mask is sold as sterile and are intended to be single use, disposable devices.

Here's a breakdown of the acceptance criteria and study information for the "Medical Surgical Mask" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Lot 1: 31 Out of 32 pass at 160mmHg (21.3 kPa)
• Lot 2: 31 Out of 32 pass at 160mmHg (21.3 kPa)
• Lot 3: 32 Out of 32 pass at 160mmHg (21.3 kPa) |
  | Particulate Filtration Efficiency ASTM F2299 | Evaluate the Particulate Filtration Efficiency | ≥ 98% | Pass
• Lot 1: 99.02%-99.58%
• Lot 2: 99.05%-99.59%
• Lot 3: 99.10%-99.68% |
  | Bacterial Filtration Efficiency ASTM F2101 | Evaluate the Bacterial Filtration Efficiency | ≥ 98% | Pass
• Lot 1: 98.8%-99.7%
• Lot 2: 98.7%-99.5%
• Lot 3: 98.9%-99.5% |
  | Differential Pressure (Delta P) MIL-M-36954C | Evaluate the Differential Pressure (Delta P) |

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The Disposable Medical 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 the potential exposure to blood and body fluids. This a single use, disposable device(s), provided sterile.

The Disposable Medical Surgical Mask is composed of mask body, nose clip and ear loop. The body of the mask is composed of 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 nose clip is made of plastic materials and iron wire, ear loop is made of spandex.

The size of the Disposable Medical Surgical Mask is 17.5*9.5cm with tolerance +/- 0.2cm, the length of the ear loop is 17cm with tolerance +/-5 cm, and the length of the nose clip should no less than 8.0cm.

The outer layer of Disposable Medical Surgical Mask will be provided in blue, the inner layer of the Disposable Medical Surgical Mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.

This document describes the premarket notification for a Disposable Medical Surgical Mask. It does not contain information about an AI/ML powered device, so I cannot answer your questions as they pertain to the criteria for AI/ML powered medical devices.

The document discusses the substantial equivalence of the proposed device to a legally marketed predicate device, focusing on material composition, intended use, and performance characteristics consistent with surgical masks.

However, I can extract the acceptance criteria and performance results for this non-AI medical device.

1. A table of acceptance criteria and the reported device performance

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