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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 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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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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Aurelia Surgical Masks ASTM Level-3 (2130) is intended for use to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device and provided non-sterile

The Aurelia Surgical Masks ASTM Level 3 are constructed with three layers of nonwoven polypropylene. The direct body contact materials include polypropylene, polyurethane, and nylon. The indirect body contacting materials include polypropylene and aluminum wire coated with melt-blown polypropylene embedded within the three layers.

The provided text is a 510(k) summary for the Aurelia Surgical Mask ASTM Level-3 (2130). It details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than a study proving a device meets AI/ML acceptance criteria.

Therefore, many of the requested data points (like sample size for test/training sets in an AI/ML context, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training) are not applicable to this document. This document describes the testing of a physical medical device (a surgical mask) against established performance standards for such devices.

Here's a breakdown based on the provided text, focusing on the relevant information:

Acceptance Criteria and Device Performance for Aurelia Surgical Mask ASTM Level-3 (2130)

This section describes the performance testing of a physical product (surgical mask) against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of masks) used for each individual test. It refers to "non-clinical tests" conducted to verify design specifications. The data provenance is implied to be from laboratory testing related to the device manufacturer (Supermax Healthcare Canada), rather than patient data. The tests are "non-clinical" and therefore do not involve retrospective or prospective human subject data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is not an AI/ML diagnostic device requiring expert consensus for ground truth on medical images or conditions. The "ground truth" here refers to the physical properties and performance metrics of the surgical mask, established through standardized laboratory testing methods (e.g., measuring filtration efficiency, pressure differential).

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML medical device.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth is based on established objective performance standards and test methods (e.g., ASTM F2101-19 for Bacterial Filtration Efficiency, ISO 10993 for biocompatibility). These standards define what constitutes a "pass" or "fail" for the specified performance characteristics of a medical face mask.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is involved for this type of device.

In summary, this document is a regulatory submission for a physical medical device (surgical mask), providing evidence of its performance against established industry standards. It does not pertain to the development or validation of an AI/ML diagnostic or therapeutic device.

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Surgical Face 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 non sterile.

The Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ties and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the straps are made of nonwoven fabrics, the middle layer is made of melt blown fabrics.

The model of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.

The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.

The ties/ear loops are not made with natural rubber latex. The nose piece on the layers of face mask is to allow the user to fit the face mask around their nose, which is made of Polypropylene with iron core. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

This document is a 510(k) summary for a Surgical Face Mask. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual performance test (BFE, differential pressure, PFE). However, for Resistance to penetration by synthetic blood and Flame spread, it states that 32 test articles were used.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. Given this is a 510(k) submission for a Chinese manufacturer (Xiantao Daoqi Plastic Co., Ltd.) and tests are cited against international (ISO) and US (ASTM) standards, the testing was likely conducted in laboratories, possibly in China or other accredited facilities. The nature of these tests (bench testing) implies they are prospective assessments of product samples.

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

This information is not applicable to this type of submission. The ground truth for these medical device tests (surgical face mask performance and biocompatibility) is established by adherence to recognized international and national standards (ASTM, ISO). These standards define specific methodologies and acceptance criteria. No human experts are involved in establishing "ground truth" in the way they would for a diagnostic AI study. The "experts" are the technicians performing the standardized tests and interpreting the results against the defined criteria.

4. Adjudication method for the test set

This information is not applicable. The tests are objective measurements against predefined criteria in recognized standards. There is no adjudication process involving multiple human observers or adjudicators for these types of physical and chemical tests.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-powered clinical decision support systems, not for a physical device like a surgical face mask.

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

No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device. The device is a physical surgical face mask.

7. The type of ground truth used

The "ground truth" for this device is established by objective measurements and assessments against recognized performance and biocompatibility standards (ASTM F2100-23, ASTM F2101-23, ASTM F1862/F1862M-17, ISO 10993-5, ISO 10993-23, ISO 10993-10). These standards define the acceptable range of physical properties and biological responses for surgical masks.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI or machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for a training set.

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