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The BioFriend™ BioMask™ N95 surgical respirator is a single use NIOSH-approved, disposable N95 surgical respirator 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™ N95 surgical respirator inactivates 99.99% of tested influenza viruses on five minutes contact with the surface of the respirator 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/Californial04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/PuertoRico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/TurkeyWisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine fly sublype: H1N1 (A/Swine/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/Florida/4/2006, B/Lee/1940), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.

The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional BF-200-3013AN is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The device is intended to be worn during seasonal Influenza A or Influenza B, and an Influenza A or Influenza B pandemic. It is intended for occupational use, to help reduce wearer exposure to pathogenic biological airborne particulates, and to protect against the transfer of micro-organisms, body fluids, and particulate material.

The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional (BF-200-3013AN) is flatfolded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The respirator is 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 this device are typical construction materials commonly used in surgical facemasks and N95 surgical respirators and being used in current legally marketed devices. The outer active layer of the respirator is coated with a hydrophilic plastic. The second inner layer is treated with copper and zinc ions. Both layers inactivate influenza viruses using different mechanisms of action.

Here's a breakdown of the acceptance criteria and study information for the BioFriend™ BioMask™ N95 Surgical Respirator, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document details performance against recognized standards, specifically ASTM F2100-11 for Medical Face Masks and NIOSH 42 CFR 84 for Respirator Certification. It also includes virucidal efficacy claims.

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

The document does not explicitly state the sample sizes for each specific test (e.g., number of masks tested for BFE, PFE, etc.). However, it indicates that "All testing was carried out in compliance with the Good Laboratory Practice (GLP) regulations," implying standardized and sufficient sample sizes as per GLP.

• Data Provenance: The tests were conducted by independent laboratories:
  • Nelson Laboratories Inc., Salt Lake City, UT, USA: For bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.
  • Microbiotest Inc., Sterling, VA, USA: For Virucidal Efficacy testing.
• Retrospective or Prospective: These appear to be prospective nonclinical laboratory tests specifically conducted for the device's clearance.

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

This section is Not Applicable as the studies described are non-clinical, laboratory-based performance tests of the device's physical and antimicrobial properties, not assessments requiring expert interpretation of medical images or patient outcomes. The "ground truth" is established by the standardized test methods themselves.

4. Adjudication Method for the Test Set:

This section is Not Applicable for the same reasons as point 3. There is no human interpretation or adjudication required for these objective performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies presented are laboratory performance tests of the device's material properties and virucidal efficacy, not clinical studies involving human readers or patient cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This concept typically applies to AI/software as a medical device. Since the device is an N95 surgical respirator, and not an AI algorithm, this section is Not Applicable. The performance described is the standalone performance of the physical device.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on:

• Standardized Test Methods and Definitions: The "ground truth" for parameters like BFE, PFE, differential pressure, fluid penetration, and flame spread is defined by the specific ASTM, MIL, 16 CFR, and NIOSH standards and their associated methodologies.
• Laboratory-Confirmed Viral Inactivation: For virucidal efficacy, the "ground truth" is the empirically measured reduction in viable virus particles (e.g., cell culture assays) after contact with the mask material under controlled laboratory conditions, as observed and quantified by Microbiotest Inc.

8. The Sample Size for the Training Set:

This section is Not Applicable. The BioFriend™ BioMask™ N95 Surgical Respirator is a physical medical device, not an AI/machine learning model that requires a 'training set.' Its performance characteristics are determined through manufacturing specifications and subsequent testing against established standards.

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

This section is Not Applicable as there is no training set for this type of device.

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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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