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Disposable Medical 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 Disposable Medical Mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into four layers, the inner, second and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of galvanized iron wire, the ear loops are made of polyester and spandex, and the ties are made of polypropylene. The Medical Surgical Mask will be provided in green. The Disposable Medical Mask is sold as sterile and are intended to be single use, disposable devices.

This document primarily details the non-clinical testing and substantial equivalence determination for a Disposable Medical Mask (K222545) in comparison to a predicate device (K211454). It is not a study that proves a device meets acceptance criteria through a clinical or reader study involving human interpretation of AI results.

This submission is for a medical mask, which is a physical device, and the "acceptance criteria" discussed are primarily related to its physical and biological performance characteristics (e.g., filtration efficiency, fluid resistance, biocompatibility), not the performance of an AI algorithm. Therefore, many of the requested points, such as those related to AI algorithm performance, human expert adjudication, MRMC studies, and ground truth establishment for AI training/testing, are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and performance of the mask itself based on the provided text.

Acceptance Criteria and Device Performance (Applicable to the physical mask device)

The document details the performance testing of the Disposable Medical Mask against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Synthetic Blood Penetration: 32 samples (stated as "32 out of 32 pass at 160 mmHg"). For acceptance, it states "29 samples out of 32 pass (AQL 4%)".
• Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): Specific sample sizes are not explicitly stated for each test, but standard test methods (e.g., ASTM, ISO) typically specify the number of samples required.
• Data Provenance: Not explicitly stated as retrospective or prospective given this is laboratory testing of a physical product. The manufacturer is Guangzhou Fuzelong Hygiene Material Co., Ltd, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This document describes laboratory performance testing of a physical medical device (a mask), not the evaluation of an AI algorithm's diagnostic performance requiring human expert ground truth. The "ground truth" here is the objective measurement of the mask's physical properties against defined standards.

4. Adjudication method for the test set:

• Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI device.

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

• No. This is not an AI device.

7. The type of ground truth used:

• The "ground truth" for the mask's performance is based on objective measurements against pre-defined international and national standards (e.g., ASTM, EN, ISO, 16 CFR). For example, "Level 3 pass at ≥98%" for filtration efficiency is the acceptance criterion acting as the "ground truth."

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a "training set."

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

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The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids.

The Disposable Medical Masks are single use, three-layer, flat-folded masks with ear loops and nose clamp. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric, and the middle layer is made of melt blown Fabric. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made of Polyamide & Spandex. The nose clamp in the layers of face mask is to allow the user to fit the face mask around their nose, which is made of galvanized iron wire wrapped with PE material. The Disposable Medical Masks will be provided in white, blue, and purple which are sold non- sterile and are intended to be single use, disposable devices.

This document describes the acceptance criteria and the results of a study demonstrating that the "Disposable Medical Masks" device, manufactured by Hantech Medical Device Co., Ltd., meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable 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. This is a single use, disposable device(s), provided non-sterile.

The Disposable Medical Masks are single use, three-layer, flat -folded masks with ear loops and nose clip. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven 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 strings welded to the facemask. The ear loops are made of 17cm spandex elastic strings(performance of the spandex elastic: Tensile strength> 100N; Elasticity>=2.8times; Breaking tension>=100N) The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.

This document is a 510(k) premarket notification for a Disposable Medical Mask. It is for a physical medical device (mask), not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as multi-reader multi-case studies, expert adjudication, training set ground truth, etc.) are not applicable here.

However, I can extract information related to the acceptance criteria and non-clinical testing performed for this medical mask.

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Medical 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. It is a single use, disposable device(s), provided non-sterile.

The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's 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 mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device. This product contains no components made from natural rubber latex.

This document is a 510(k) premarket notification for a medical device: a Disposable Medical Mask (K212826). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a set of acceptance criteria through a clinical study that uses AI or human readers for diagnosis. Therefore, several aspects of your request (related to AI, human readers, ground truth establishment for a training set, the number of experts, and adjudication methods for a test set) are not applicable to the content provided.

However, I can extract the acceptance criteria and performance data for the physical properties and biocompatibility of the medical mask, as these are the "device performance" aspects evaluated in this submission for regulatory clearance.

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

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

The document presents performance criteria for the Disposable Medical Mask based on established ASTM and EN standards for medical face masks.

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The surgical face masks (Ear loops) 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 are Non-sterile, single use, 3 layers, flat-pleated style with mask belt and nose clip. The outer layer and inner facing layer of face mask consist of spunbond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains mask belt to secure the mask over the user's face and mouth with nose clip to firmly fit over the nose. This device is not made from any natural rubber latex.

The provided document (K210222) is a 510(k) premarket notification for a Disposable Medical Mask. This type of device is a Class II medical device, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device (K160269) through performance testing against established standards for medical masks, rather than a clinical study involving human subjects or AI algorithm validation data.

Therefore, many of the requested points, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "training set establishment," etc., are not applicable to this specific submission. The "acceptance criteria" here refer to meeting the performance requirements for physical properties of the mask as per recognized standards (e.g., ASTM F2100-19), not diagnostic accuracy or clinical outcomes assessed by an algorithm.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data are primarily derived from standard test methodologies for medical face masks.

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The Disposable 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. This is a single use, disposable device(s), provided non-sterile.

The Disposable Medical Masks are non-sterile, single use, 3 layers, flat-pleated style surgical masks. Each mask contains ear loops made of nylon and spandex to secure the mask over the user's face and mouth with nose piece made of polypropylene to firmly fit over the nose. The size of the mask body is 14 cm×9 cm and the dimension of the ear loop is 8 cm × 0.3 cm, the dimension of nose piece is 9.4 cm×0.3 cm. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene. Color of the inner facing layer of the mask is white and color of the outer facing layer is blue. The middle layer consists of white Melt Blown Polypropylene Filter.

50 masks are packed in a polyethylene plastic bag and placed in the package box made of white cardboard. Outside the package box there is also a PE plastic film cover on the box. This device is not made from any natural rubber latex.

The document describes the acceptance criteria and performance of the Disposable Medical Mask (Model: RYSM001) manufactured by Yangzhou Runyi Arts & Crafts CO., LTD. It is a 510(k) summary demonstrating substantial equivalence to a predicate device (Single-use Medical Face Mask, K203591 from Conod Medical Co., Limited).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Medical 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 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.

Model: k0450, blue color, and Level 2 barrier level per ASTM F2100.

Disposable Medical Mask are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.

This document is a 510(k) summary for a Disposable Medical Mask (Model: k0450). It focuses on demonstrating substantial equivalence to a predicate device. The information provided is for a medical device (surgical mask), not a software or AI device. Therefore, the concepts of human readers, AI assistance, effect size, training sets, and ground truth establishment in the context of AI/ML models are not applicable to this document.

The acceptance criteria and performance data pertain to the physical characteristics and barrier performance of the surgical mask.

1. Table of acceptance criteria and the reported device performance

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Disposable Medical Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Disposable Medical Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Mask is sold non-sterile and is intended to be a single use, disposable device.

Here's a breakdown of the acceptance criteria and study information for the "Disposable Medical Mask," based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face 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 non-sterile. It is intended for adults only (greater than 21 years of age).

The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's 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 mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device.

The provided document is a 510(k) summary for a disposable medical mask. It details the device's technical characteristics and performance testing against established standards, primarily for determining substantial equivalence to a predicate device.

Here's the information requested based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is seeking to meet Level 2 classification according to ASTM F2100-19.

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