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The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).

The ProGear® Surgical Mask with Oxafence® inactivates of the following test viruses after five minutes of contact with the treated surface of the face mask in laboratory (in vitro) tests under a lighting intensity of 500 ± 25 lux.

Influenza A/PR/8/34/H1N1 (TC adapted, ATCC VR-1469), 3-log or 99.9% inactivation Betacoronavirus 1 OC43 (ATCC VR-1558), 4-log or 99.99% inactivation Feline Calicivirus F-9 (ATCC VR- 782), 4-log or 99.99% inactivation

Antiviral efficacy on other viruses has not been evaluated. Correlations between in vitro testing results and any clinical event have not been evaluated.

The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).

This document is a letter from the FDA regarding the clearance of a surgical mask, not a study report for an AI/ML device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement in the context of an AI/ML device.

The provided text describes the "Indications for Use" for the ProGear® Surgical Mask with Oxafence®, Model AV82030, and lists the antiviral efficacy against specific viruses in laboratory (in vitro) tests. This information pertains to the performance of the physical device as a surgical mask, not a software or AI/ML product.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device from this document.

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The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6%) that inactivate influenza viruses.

The Innonix Anti-Influenza Child's Face Masks, (both Model BF-200-3015A and BF-200-2005A) comprise four layers of material: an outer layer of spun bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bond polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and being used in current legally marketed devices, and are not made with natural rubber latex. The outer active layer of the face mask is coated with a hydrophilic plastic containing citric acid. The second inner layer is treated with copper and zinc ions. Both of these layers inactivate influenza viruses using different mechanisms of action (pH lowering and ionic disruption).

Model: BF-200-3015A is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.

Model: BF-200-2005A is a flat pleated mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.

This document is a 510(k) premarket notification for the Innonix Anti-Influenza Child's Face Mask, detailing its acceptance criteria and non-clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

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The Cufitec Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids and has an anti-influenza agent (active ingredient: Cul at 0.5% wt. concentration) on the outer and inner mask layers.

The Cufitec Surgical Mask inactivates 99.90% of the following influenza viruses on five minutes contact with the surface of the facemask in laboratory (in vitro) tests against the following influenza viruses:

Influenza A/H1N1: A/WS/33, A/Virginia/ATCC2/2009; Influenza A/H3N2: A/Kitakyusyu/159/93, A/Udorn/307/72, A/Hong Kong/8/68, A/Victoria/210/09, A/Virginia/ ATCC6/2012; Influenza B: B/Lee/40, B/Taiwan/2/62; under tested contact conditions.

Correlations between in vitro testing results and any clinical event has not been tested.

The Cufitec® Surgical Mask is a single-use, disposable device, provided non-sterile, and is intended to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids, and particulates and has an added anti-influenza agent which inactivates specific pathogens under specified contact conditions. The mask is comprised of four layers of materials: rayon layers with added anti-influenza coating (outer and inner layers) and polypropylene layers (two middle layers). All of the construction materials used in this device are commonly used in the construction of surgical facemasks used in current legally marketed devices. The inner and outer layers are coated with an anti-influenza agent (CuI, 0.5% wt.), which inactivates influenza viruses under tested contact conditions using the same mechanism of action. Masks are held in place on the wearer with ear loops (polyurethane and nylon) and contains a malleable polyethylene nosepiece strip to conform to the wearer's face.

This document describes the premarket notification for the Cufitec Surgical Mask (K182766), a Class II medical device. While it explicitly states that no clinical testing was required or performed (Section 6, Table on Performance Testing, row "Clinical Testing" states "Not applicable. Same – clinical testing is not required to support the subject device."), it details extensive non-clinical performance and antiviral testing to demonstrate substantial equivalence to its predicate device.

Therefore, the requested information regarding "human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," and the "ground truth used (expert consensus, pathology, outcomes data, etc.)" for AI validation is not applicable to this specific submission, as it concerns a physical surgical mask and not an AI/algorithm-based device.

However, I can extract information related to the acceptance criteria and study proving the physical device meets these criteria, focusing on the non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of masks or viral samples) used for each non-clinical performance and antiviral test. It mentions "test articles" and "samples" but not the quantity for each specific test.

• Data Provenance: The tests are explicitly described as "laboratory (in vitro) tests." The submitter is NBC Meshtec Inc. based in Tokyo, Japan, and the official US correspondent is Globizz Corporation in Gardena, California. It can be inferred that the testing was conducted in a laboratory setting, likely either in Japan or a contracted lab. The data is retrospective in the context of the submission, as the tests were completed and results reported prior to the FDA review.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the submission pertains to a physical medical device (surgical mask) and its non-clinical performance characteristics, not an AI/algorithm-based diagnostic device requiring human expert ground truth.

4. Adjudication Method for the Test Set

Not applicable for a physical device's non-clinical performance testing.

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

Not applicable. No clinical or human-reader studies were conducted for this device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Standardized laboratory protocols and measurements: Adherence to ASTM, ISO, and MIL standards for physical performance (fluid resistance, filtration, flammability).
• Validated laboratory assays: For antiviral efficacy, the "ground truth" is the empirically measured viral reduction (log kill) under controlled in vitro conditions, with specific viral strains and contact times. This is based on established microbiological testing methods.
• Chemical and biological characterization: For biocompatibility and active ingredient concentration, the "ground truth" is based on analytical chemistry and toxicology principles, confirmed by tests like ISO 10993 series.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this product would be the iterative design and manufacturing process of the mask itself, involving material selection and coating application, which is not quantified as a "training set" in the context of AI.

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

Not applicable as there is no "training set" in the AI/ML sense. The product's development would have been guided by engineering and materials science principles, aiming to meet the performance criteria established by relevant standards and the intended antiviral claims.

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The BioFriend™ BioMask™ surgical facemasks are single use disposable devices with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2% w/w, a pH lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% w/w and zinc 1.6% w/w, which form ionic bonds with negatively-charged side-groups on influenza viruses).

The BioFriend™ BioMask™ surgical facemasks inactivate 99.99% of Influenza viruses on five minutes contact with the surface of the facemask in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and equine influenza viruses: influenza A subtypes and strains: H1N1 (the 2009 pandemic flu subtype A/California/07/09, A/Brisbane/59/2007, A/Wisconsin/10/98, A/New Jersev/8/76. A/PR/8/38), A/PR/8/38 H3N2 (A/Brisbane/10/2007.A/Wisconsin/67/2005.). H2N2 (A/2JAPAN/305/57); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/Turkey/Wisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine flu subtype: H1N1 (A/Swine/1976/31); the equine flu subtype: H3N8 (A/Equine/2/Miami/63); and Influenza B strains: (B/Florida/4/2006, B/Lee/40), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.

There are two models: (1) Universal (BF-200-2001A) - a standard flat mask with pleats; (2) Premium (BF-200-3013A) - flat-folded and expanding into a convex-shaped mask with ear adjusters and an antifog nose flap. No clinical studies have been conducted comparing the ability of an untreated facemask and these facemasks to protect the wearer from Influenza infection. They are intended to be worn by operating room personnel during surgical procedures, to protect both the surgical patient, and the operating room personnel, from the transfer of microorganisms, body fluids and particulate material.

The BioFriend™ BioMask™ surgical facemask is offered in two mask styles, Model: BF-200-2001A ("Universal") and Model: BF-200-3013A ("Premium"). The Universal model is a standard flat mask with pleats, while the Premium model is flat-folded and expands into a convex-shaped mask. The Premium model also has ear adjusters and an anti-fog nose flap. Both models are comprised of four layers of material: an outer layer of spun-bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bound polypropylene. All of the construction materials used in these devices are typical construction materials commonly used in surgical facemasks and are being used in current legally marketed devices. The outer is coated with a hydrophilic plastic. The second inner layer is treated with copper and zinc. Both layers inactivate influenza viruses using different mechanisms of action. Masks are held in place on the wearer with elastic loops and contain a malleable metal nosepiece strip.

The provided document describes the BioFriend™ BioMask™ Surgical Facemask and its substantial equivalence to a predicate device, focusing on non-clinical performance criteria rather than acceptance criteria for an AI/ML device study. Therefore, some of the requested information, specifically related to AI/ML study design, ground truth establishment for AI/ML, and expert review, cannot be extracted from this document."

Acceptance Criteria and Device Performance (Non-AI/ML)

The BioFriend™ BioMask™ Surgical Facemask is designed to meet performance standards for surgical facemasks. The primary acceptance criteria provided relate to the mask's ability to inactivate influenza viruses and its physical properties.

Table of Acceptance Criteria and Reported Device Performance

Information Regarding AI/ML Study Design (Not Applicable)

The provided document describes a medical device (surgical facemask) that uses materials science and chemical properties for its functionality, specifically for viral inactivation. It does not describe an Artificial Intelligence (AI) or Machine Learning (ML) device. Therefore, the following requested information points related to AI/ML studies are not applicable and cannot be extracted from this document:

1. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML study. The "test set" in this context refers to samples used for laboratory testing of the mask's physical and viral inactivation properties.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is established through standardized laboratory tests, not through expert consensus on AI/ML outputs.
3. Adjudication method for the test set: Not applicable. Standardized lab test results are typically objective measurements.
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 device does not involve human "readers" or AI assistance. The document explicitly states: "No clinical studies have been conducted comparing the ability of an untreated facemask and these facemasks to protect the wearer from Influenza infection."
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
6. The type of ground truth used: For the viral inactivation, the ground truth is the experimentally measured reduction in virus infectivity in laboratory settings. For physical properties, the ground truth is the direct measurement of these properties against established standards.
7. The sample size for the training set: Not applicable. There is no AI/ML training set.
8. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.

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