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The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring 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 subject Disposable Surgical Face Masks has two models, that is Model: 3P00B, ASTM F2100 Level 2 and Model: C2900, ASTM F2100 Level 3.

The Disposable Surgical Face Masks (Model: 3P00B, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, middle layer and outer layer. The colorant is blue master batch. The inner layer and outer layer of 3P00B mask are made of spun-bond non-woven fabric, the middle layer is made of Polyethylene Melt-blown non-woven fabric.

The Disposable Surgical Face Masks (Model: C2900, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, second layer, filtration layer and outer layer. The colorant is blue master batch.

The inner layer and outer layer of C2900 are made of spun-bonded non-woven fabric, the second layer is made of Polyethylene PE film, the filtration layer is made of Polyethylene Melt-blown non-woven fabric.

The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with Polyester and spandex. The aluminum nose piece in the layers of face mask is to allow the user to form the mask around their nose.

The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.

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The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical 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.

The Disposable Medical Face Mask is single use, three-layer, 3-pleated or 4-pleated flat-folded masks with nose piece and ear loops or ties. The masks will be provided in blue or black color with option for a visor. The colorant is polypropylene (PP) master batch.

The body of the mask is composed of three layers: the inner and outer layers are made of spun-bond polypropylene, the 2nd layer is made of melt blown polypropylene. The only difference between Level 1, Level 2, and Level 3 masks is the material density in the middle layer. The nose piece is made of Iron wire covered with polypropylene plastic, ear loop is made of elastic band, the ties are made of spun-bond polypropylene, and the visor is made of polyethylene terephthalate (PET).

Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex.

The disposable medical face masks are sold non-sterile and are intended to be single use, disposable devices.

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The KP Protective Face Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The KP Protective Face Mask is a non-sterile, single-use surgical mask intended to cover the user's nose and mouth, providing a physical barrier to fluids, microorganisms, and particulate matter.

The mask consists of three nonwoven polypropylene layers, including:

• Outer layer: Spunbond non-woven
• Filter layer: Melt-blown polypropylene
• Inner comfort layer: Spunbond non-woven
• Nose wire: Polypropylene-clad adjustable wire
• Attachment: Elastic earloops (A mixture of nylon and polyurethane)

The mask is white, flat-fold style, supplied non-sterile, and packaged in standard pouches.

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The VR® Personal Protective Level 3 Gown is intended to protect healthcare patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The VR® Personal Protective Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the VR Gown is open and non-protective. The VR Gown is not intended for use in the operating room.

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The HALYARD* Adult Face Mask(s) 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 of the wearer to blood and body fluids. These are single use, disposable device(s), provided non-sterile.

The HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops, is a three-layer mask, constructed of well-known non-woven materials. The mask is provided with earloops and a malleable nosepiece, placed within the bindings for comfort, to conform to the curvature of the wearer's nose.

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Level 3 Surgical Gown (Standard & Reinforced) are sterile, single-use surgical apparel intended to be worn by healthcare professionals during surgical procedures to provide barrier protection against the transfer of microorganisms, body fluids, and particulate matter in critical surgical zones for both patients and healthcare personnel.

The products meet the respective liquid barrier performance requirements for Level 3 as specified in ANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities".

Surgical Gowns are class II medical devices under the FDA product code FYA, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The subject surgical gowns are single use, disposable and provided sterile. They are available as Standard or Reinforced at Critical areas of the gown to increase its resistance to fluid penetration. The gowns are designed for short to medium length procedures and procedures where there is moderate risk (AAMI PB70 level 3).

The subject gowns are single-use and provided sterile (Ethylene Oxide sterilization). The subject gowns provide barrier protection against the transfer of microorganisms, body fluids, and particulate matter in critical zones of the gowns for both patients and healthcare personnel.

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PRIMED Surgical masks are single use, non-sterile, disposable products intended to be worn by healthcare personnel in healthcare settings and during surgical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials.

PRIMED Procedure Masks are single use, non-sterile, disposable products intended to be worn by healthcare personnel in healthcare settings to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials.

PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a melt-blown filter layer placed between layers of non-woven inner and SS outer layer(s) material. PRIMED Medical Products Inc. offers various models in two main categories: Procedure masks with ear loops and Surgical masks with head ties. The level of protection varies based on the basis weight of the inner layer and the number of outer layers used in the mask's construction, in accordance with ASTM F2100:2023 specifications.

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Vitaform Procedural Masks are intended to be worn to protect both the patient and the healthcare worker from transfer of microorganisms, body fluids, and particulate material. They are single-use and intended for use in infection control practices to reduce potential exposure to blood and body fluids.

Vitaform Procedural Mask (henceforth referred to as "Vitaform")

The Vitaform Procedural Mask is a single-use, three-layered, fish-shaped surgical mask with ear loops and an aluminum nose piece. The inner and outer layers are made of spunbond polypropylene, and the middle filter layer consists of meltblown polypropylene. The ear loops are made of PET and Spandex material, and worn around the ears to keep the mask close to the face. The nose piece is a flexible aluminum strip that is fitted over the nose so that the mask conforms better to the user's face.

The Vitaform Procedural Mask is provided in the color blue. It is non-sterile and intended to be a single-use, disposable medical device.

Vitaform Procedural Mask with Shield (henceforth referred to as "Vitaform-FS")

The Vitaform Procedural Mask with Shield is a single-use, fish-shaped surgical mask with ear loops and an aluminum nose piece. The inner and outer layers are made of spunbond polypropylene, and the middle filter layer consists of meltblown polypropylene. The insertion layer that provides structural support is made of thermal-bonded polypropylene. The ear loops are made of PET and Spandex material, and is worn around the ears to keep the mask close to the face. The nose piece is a flexible aluminum strip that is fitted over the nose so that the mask conforms better to the user's face. The mask also contains a face shield (FS) made from a polyethylene terephthalate film, and an anti-reflective flap. The face shield is welded to the upper half of the mask to cover the upper part of the face.

The Vitaform Procedural Mask with Shield is provided in the color blue. It is non-sterile and intended to be a single-use, disposable medical device.

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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

Study Details (Applicable to Face Mask Device)

Given that the device is a medical face mask, the "study" primarily consists of non-clinical, laboratory-based performance and biocompatibility testing, not clinical trials or AI performance evaluations as would be done for software.

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

   • Sample Size: Not explicitly stated in terms of number of masks or test replicates for each test, but standard test methodologies (e.g., ASTM F1862/F1862M-24, ASTM F2101-23) typically specify a minimum number of samples. The results are given for specific "lots" (e.g., Yellow mask (Level 1), White mask (Level 1), Blue mask (Level 1, 2, 3)), implying that multiple samples from these production lots were tested.
   • Data Provenance: Not explicitly stated. The manufacturer is Winner Medical Co., Ltd. from Shenzhen, China. This indicates the testing was likely conducted in China or by labs accredited to perform these standards. The tests are "Non clinical tests," meaning they are laboratory experiments rather than human subject or retrospective studies.

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

   • Not Applicable. For this type of device (medical mask), "ground truth" is established by adherence to validated, objective, and standardized laboratory test methodologies and measurements, not by expert human interpretation (like in imaging for AI). The tests measure physical and biological properties directly.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable. Adjudication methods are relevant for human interpretation tasks (e.g., reading medical images) where there can be inter-reader variability. These are objective, quantitative laboratory tests.

4. 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:

   • Not Applicable. This is a physical medical device (mask), not an AI-powered diagnostic tool. MRMC studies are used to assess the performance of AI systems in combination with human readers.

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

   • Not Applicable. This is a physical medical device (mask), not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Objective Laboratory Measurements/Standards. The "ground truth" for this device is based on the objective measurements obtained through the specified ASTM, EN, CFR, and ISO standards (e.g., bacterial filtration efficiency percentage, differential pressure values, absence of penetration by synthetic blood, flammability class, cellular toxicity grading, sensitization response). These are empirical, quantitative, and qualitative results from standardized test protocols.

7. The sample size for the training set:

   • Not Applicable. This is a physical device being tested against performance standards, not an AI/ML algorithm that requires a "training set."

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

   • Not Applicable. As above, no training set for an algorithm is involved.

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The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) 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 of the wearer to blood and body fluids. Fluidshield* 3 Surgical Masks(s) and Fluidshield* 3 Procedure Face Mask(s) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM F2100 Level 3 (orange in color) Surgical and Procedure Mask(s). The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Masks family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops. A malleable nosepiece is placed within the bindings to conform around the wearer's nose. The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.

This document describes the FDA 510(k) clearance for several Fluidshield® 3 Surgical and Procedure Masks. However, it does not contain the level of detail regarding study design, sample sizes, ground truth establishment, or expert qualifications that would be present in a comprehensive study report for an AI/software device. The information provided is typical for a medical device clearance describing performance characteristics and compliance with standards, not for an AI comparative effectiveness or standalone study.

Based on the provided text, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Based on available information in the document)

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

   • Sample Size: Not specified in the provided document. The document lists "Pass" for various tests, but does not detail the number of masks or samples tested for each criterion.
   • Data Provenance: Not specified. The tests are non-clinical (laboratory-based) tests of the physical properties and performance of the mask materials and construction. They are not based on patient data, but rather on material testing.

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

   • Not applicable as this is not an AI/software device study involving expert interpretation of data. The "ground truth" here refers to the quantitative results of standardized non-clinical material performance tests, performed by laboratory personnel according to the specified ASTM and ISO standards.

4. Adjudication method for the test set:

   • Not applicable. The performance is measured against objective, standardized physical testing methods rather than subjective expert consensus requiring adjudication.

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:

   • Not applicable. This document is for the premarket notification (510(k)) of physical medical devices (surgical masks), not an AI/software as a medical device (SaMD). Therefore, no MRMC study or AI performance evaluation was conducted.

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

   • Not applicable. This is not an AI/software device.

7. The type of ground truth used:

   • The "ground truth" for the performance claims of these masks is based on standardized non-clinical laboratory testing results as defined by the ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards listed (e.g., ASTM F2100, ASTM F2101, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993). These are objective, measurable physical properties and biocompatibility assessments.

8. The sample size for the training set:

   • Not applicable. This is not an AI/software device and therefore does not involve training sets.

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

   • Not applicable. No training set is involved.

Summary of the Study:

The "study" referenced in this document is a series of non-clinical laboratory tests to demonstrate that the Fluidshield® 3 Surgical and Procedure Masks meet established performance standards for medical face masks, specifically ASTM F2100 Level 3. These tests evaluate properties such as bacterial filtration efficiency, particulate filtration efficiency, differential pressure (breathability), fluid resistance, flammability, and biocompatibility (cytotoxicity, sensitization, irritation).

The conclusion states that the nonclinical tests demonstrate the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, forming the basis for its 510(k) clearance for market.

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