(266 days)
Actiprotect™ UC N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of Influenza A viruses (tested against Influenza A subtypes H1N1 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer laver of the respirator when tested in vitro against the following influenza A viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007)) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for use by the general public in public health medical emergencies. Effectiveness tested against specific Influenza A and Influenza A pandemic strains. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. Actiprotect™ UC N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
Actiprotect™ UC N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic elastic straps are stapled or welded to the edge of the respirator and are used to secure the respirator to the user's face.
The provided text describes the Actiprotect™ UC N95 Respirator, a filtering facepiece respirator. The information focuses on its substantial equivalence to predicate devices and its performance in various nonclinical tests, rather than a typical AI-driven diagnostic device study. Therefore, many of the requested categories for AI device studies are not applicable.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for each criterion. Instead, it describes various tests performed and implies that the device passed these tests, leading to a determination of substantial equivalence. The key performance claims relate to filtration efficiency and virus inactivation.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Fluid Penetration Resistance | Passed ASTM F1862 |
| Particulate Filtration Efficiency | Passed NIOSH 42 CFR 84.181 |
| Bacterial Filtration Efficiency (BFE) | Passed MIL M36954C, ASTM F2101 |
| Flammability | Passed 16 CFR 1610 |
| Breathing Resistance | Passed NIOSH 42 CFR 84.180 |
| Virus Inactivation (Influenza A) | Kills (inactivates) 99.99% of Influenza A viruses within one minute of contact with the surface. Includes specific H1N1 (including 2009 pandemic strain), H2N2, H3N2, H5N1, H5N9 subtypes. |
| Virus Inactivation (Influenza B) | 99.99% kill (inactivation) on the surface against specific Influenza B strains under tested contact conditions. |
| Biocompatibility (Cytotoxicity) | Demonstrated biocompatible |
| Biocompatibility (Skin Sensitization/Irritation) | No evidence of sensitization or irritation in Human Repeated Insult Patch Tests. |
2. Sample size used for the test set and the data provenance
- Nonclinical Tests (Fluid Penetration, Filtration Efficiency, Flammability, Breathing Resistance): The document does not specify the sample sizes used for these tests. It simply states that the tests were conducted and passed according to the referenced standards (e.g., ASTM F1862, NIOSH 42 CFR 84.181). The data provenance is implied to be laboratory testing as part of the device development and regulatory submission process.
- Virus Inactivation: This was an "In vitro (laboratory)" test. The document does not specify the sample size (e.g., number of respirators tested) but lists a variety of Influenza A and B subtypes/strains that were tested. Data provenance is laboratory testing.
- Biocompatibility (Human Repeated Insult Patch Tests): The document states "samples of the respirator materials" were used. No specific number of human subjects is provided, but it indicates "There were no adverse reactions reported during the studies." The data provenance is from clinical (human) testing, likely conducted by the manufacturer or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a medical respirator, not an AI diagnostic device that requires expert interpretation for ground truth. Performance is determined by objective physical and chemical tests (e.g., filtration, virus inactivation, material biocompatibility).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable as the device is not an AI diagnostic device requiring human adjudication of results. Test results are based on standardized laboratory protocols.
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
This section is not applicable. The device is a personal protective equipment (respirator), not an AI system designed to assist human readers in interpreting medical cases. No MRMC study was conducted or is relevant. The submission explicitly states: "No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical product (respirator), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective measurements and standardized test methods dictated by regulatory requirements and established scientific principles for respirators and material safety.
- For Filtration and Physical Performance: Compliance with standards (e.g., NIOSH 42 CFR 84.181 for particulate filtration efficiency, ASTM F1862 for fluid penetration). The "ground truth" is the quantitative measurement obtained per the standard.
- For Virus Inactivation: Laboratory in vitro tests demonstrating a 99.99% reduction in live virus on the surface under controlled conditions. The "ground truth" is the measured reduction in viral infectivity.
- For Biocompatibility: Results from established in vitro (cytotoxicity) and in vivo (human repeated insult patch tests) methods, indicating safety for human contact. The "ground truth" is the absence of adverse reactions or toxic effects according to these tests.
8. The sample size for the training set
This section is not applicable as this is not an AI or machine learning device that requires a training set.
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.
§ 880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies.
(a)
Identification. A filtering facepiece respirator for use by the general public in public health medical emergencies is a device that is a disposable half-facepiece non-powered air-purifying particulate respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency. The device is made of polymeric materials and is intended to fit closely to the face and to function by filtering particulate material.(b)
Classification. Class II (special controls). The special controls are:(1) Certification by the National Institute for Occupational Safety and Health (NIOSH) as a non-powered air-purifying particulate respirator with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84.
(2) The FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies.” See § 880.1(e) for information on obtaining a copy of this guidance document.