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The Procedure mask/Surgical mask/Face 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 is a single-use, disposable device, provided non-sterile.

The subject device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The subject device is available in one type, ear loop. The ear loops are made of polyester and spandex. The ear loops model is held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is made of Iron and polypropylene. 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 loop masks are available in two size, 17.5 × 9.5 cm and 14.5 × 9.5 cm. And the colors for the ear loop mask are yellow, blue and white. The ear loop masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-23. This is a single-use, disposable device, provided non-sterile.

The provided document is a 510(k) Clearance Letter for a medical device: Procedure mask/Surgical mask/Face mask. This type of document, specifically the "Summary of Non-Clinical Test" section, details the performance characteristics required for the device to meet regulatory standards.

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

Important Note: The provided document is for a medical mask, not an AI-powered diagnostic device. Therefore, many of the typical questions regarding AI/software performance studies (e.g., sample size for test set, number of experts, adjudication, MRMC studies, training set details, ground truth for AI) are not applicable to this submission. The "study" here refers to physical and biological performance testing of the mask material itself.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on established standards like ASTM F2100-23, ASTM F1862/F1862M-24, ASTM F2101-23, EN 14683:2019+AC:2019, 16 CFR Part 1610, and ISO 10993 series. The table below summarizes these criteria and the reported performance:

Table 1: Acceptance Criteria and Reported Device Performance

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The Procedure mask/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 is a single-use, disposable device, provided non-sterile.

The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 3 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.

This document is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). The information provided demonstrates that the device meets the acceptance criteria through non-clinical testing.

Here's the breakdown of your requested information:

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

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The Procedure mask/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 is a single-use, disposable device, provided non-sterile.

The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 1 and level 2 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.

The provided text is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). It details non-clinical tests conducted to prove substantial equivalence to a predicate device, rather than the development and validation of an AI-powered diagnostic device.

Therefore, I cannot extract information related to:

• Study that proves the device meets acceptance criteria: The document describes non-clinical performance testing of a physical product (face mask) against established standards, not an AI model's performance.
• Sample size used for the test set and data provenance: No test set of patient data, images, or cases is mentioned. The tests are on material properties of the mask.
• Number of experts used to establish ground truth and qualifications: Ground truth for a face mask's performance is established by standardized physical and biological tests, not expert consensus on medical images or patient data.
• Adjudication method for the test set: Not applicable as there's no diagnostic test set requiring adjudication.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating human reader performance with and without AI assistance for interpretation tasks.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to the measured physical and biological properties of the mask.
• Sample size for the training set: There is no training set mentioned, as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

Instead, I can present the acceptance criteria and reported device performance from the non-clinical tests for the traditional medical device (face mask) as provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare 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 Procedure Masks / Surgical Masks with Polyethylene nose wire can be used in MRI environment.

Procedure Mask / Surgical Mask, Ear loops and Tie-On. This is a single use, disposable device(s), provided non-sterile.

The provided text is a U.S. FDA 510(k) clearance letter for a Procedure Mask/Surgical Mask. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain any information regarding the acceptance criteria, device performance testing (including details on sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details) for an AI/ML-driven device.

This document pertains to traditional medical device clearance (a surgical mask), which goes through a different evaluation process than AI/ML-driven software as a medical device (SaMD). The questions you've asked are highly relevant to the regulatory clearance of AI/ML-driven medical devices, but the provided text does not offer this information.

Therefore, I cannot fulfill your request using the given input, as the necessary information is absent.

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The Procedure Masks / 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(s), provided non-sterile.

The Procedure Masks (68-8506-G (Green, ear loop, level 1) & 68-8508-G (Green, ear loop, level 3) are single use, three-layer, flat-folded masks with ear loops, and nose wire. The Procedure Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops welded are used to keep the mask close to the nose. The elastic ear loops are not made with natural rubber latex. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The procedure masks will be provided in green. The Surgical Masks (68-8536-B (Blue, tie-on, level 1) & 68-8538-B (Blue, tie-on, level 3) are single use, threelayer, flat-folded masks with Ties, and nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in Blue. The procedure masks are sold non-sterile and are intended to be single use, disposable device.

The provided document is a 510(k) Premarket Notification for a Procedure Mask/Surgical Mask. It describes the device's technical specifications and performance testing. However, it is important to note that this document is for a medical device (a mask) and not a software or AI-based device. Therefore, many of the requested elements for describing an AI study, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or training set details, are not applicable in this context.

The document focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device by meeting certain performance criteria.

Here's the information derived from the document that is applicable to your request, formatted as closely as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against the ASTM F2100 requirements for Level 1 and Level 3 masks.

Acceptance Criteria and Device Performance for Level 1 Masks:

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DermAssist ™ Fluid Resistant Surgical Mask / Procedure Mask is a high filtration 3 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials.

Not Found

This document is a 510(k) clearance letter from the FDA for a surgical mask. It does not contain information about acceptance criteria or a study proving device performance in the way typically found for AI/ML powered medical devices. The clearance is based on substantial equivalence to a predicate device, not on specific performance metrics derived from a study like those described in your questions.

Therefore, I cannot extract the requested information from the provided text. The questions you've asked are relevant for AI/ML devices, but this document pertains to a traditional medical device (a surgical mask).

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