(399 days)
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
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|---|---|
| Viral Inactivation | Influenza virus inactivation (in vitro) | Inactivate 99.99% of Influenza viruses on five minutes contact with the surface of the facemask. | Inactivates 99.99% (≥4-logs) of 15 different strains of Influenza A and B viruses (including specific H1N1, H3N2, H2N2, H5N1, H9N2, H5N2, H3N8, and Influenza B strains) after 5 minutes contact with the mask surface. | Laboratory (in vitro) |
| Physical Barrier & Filtration | Bacterial Filtration Efficiency | Conform to recognized FDA consensus standard ASTM F2100-07. | Appropriately passed standardized tests for Bacterial Filtration Efficiency (ASTM F2101). | Non-clinical |
| Sub-micron Particulate Filtration Efficiency | Conform to recognized FDA consensus standard ASTM F2100-07. | Appropriately passed standardized tests for Sub-micron Particulate Filtration Efficiency (ASTM F2299). | Non-clinical | |
| Fluid Penetration Resistance | Conform to recognized FDA consensus standard ASTM F2100-07. | Appropriately passed standardized tests for Fluid Penetration Resistance (ASTM F1862). | Non-clinical | |
| Breathing Resistance | Conform to recognized FDA consensus standard ASTM F2100-07. | Appropriately passed standardized tests for Breathing Resistance (MIL-M-3654C). | Non-clinical | |
| Flammability | Conform to recognized FDA consensus standard ASTM F2100-07. | Appropriately passed standardized tests for Flammability (16 CFR 1610). | Non-clinical | |
| Biocompatibility | Irritation | Device as a whole shown to be biocompatible. | Appropriately passed standardized tests for Irritation (ISO 10993-10). | Non-clinical |
| Sensitization | Device as a whole shown to be biocompatible. | Appropriately passed standardized tests for Sensitization (ISO 10993-10). | Non-clinical | |
| Chemical Characterization (Extractables) | Device as a whole shown to be biocompatible. | Appropriately passed standardized tests for Chemical Characterization (ISO 10993-18). | Non-clinical |
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:
- 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.
- 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.
- Adjudication method for the test set: Not applicable. Standardized lab test results are typically objective measurements.
- 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."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- 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.
- The sample size for the training set: Not applicable. There is no AI/ML training set.
- How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.