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Actiprotect™ UF 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 layer of the respirator when tested in vitro against the following influenza 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 occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Actiprotect™ UF 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 strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.

Here's an analysis of the acceptance criteria and study information for the Actiprotect™ UF N95 Respirator, based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample Size used for the test set and the data provenance:

   • Fluid Penetration Resistance (ASTM F1862): Not specified.
   • Particulate Filtration Efficiency (NIOSH 42 CFR 84.181): Not specified.
   • Bacterial Filtration Efficiency (MIL M36954C, ASTM F2101): Not specified.
   • Flammability (16 CFR 1610): Not specified.
   • Breathing Resistance (NIOSH 42 CFR 84.180): Not specified.
   • Influenza Virus Inactivation (In vitro): Not specified.
   • Human Repeated Insult Patch Tests: Not specified.
   • Data Provenance: The document indicates that the tests (Fluid Penetration, Particulate Filtration, Bacterial Filtration, Flammability, Breathing Resistance) are standardized tests (e.g., ASTM, NIOSH, MIL). The Human Repeated Insult Patch Tests are clinical tests conducted, but the location or specific institution is not mentioned, so the country of origin is unknown. The influenza inactivation tests were performed "in vitro (laboratory) tests."

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

   • This question is not directly applicable to the types of tests reported. The studies described are primarily bench/laboratory tests (e.g., filtration efficiency, fluid penetration, flammability, virus inactivation) adhering to standardized protocols, and biocompatibility tests (human repeated insult patch tests). These types of tests do not typically involve human experts establishing a "ground truth" in the way an imaging study or diagnostic accuracy study would. The pass/fail criteria are defined by the standards themselves.

3. Adjudication method for the test set:

   • Not applicable as the tests are objective, standardized measurements with predefined pass/fail criteria. There isn't a subjective "assessment" by experts that would require adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. The document 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."
   • Effect size of human readers improvement: Not applicable, as no MRMC study was conducted.

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

   • This device is a physical N95 respirator, not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance tests described (filtration, resistance, flammability, virus inactivation, biocompatibility) are inherent to the physical device itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the performance tests (filtration, fluid resistance, etc.), the "ground truth" is defined by the established criteria of the standardized test methods (e.g., ASTM, NIOSH, MIL standards). A device "passes" if its measured performance meets or exceeds these pre-defined thresholds.
   • For the influenza inactivation, the "ground truth" is the measured viral reduction percentage (99.99%) in controlled in vitro laboratory conditions, compared against a baseline.
   • For the biocompatibility tests, the "ground truth" for safety is the absence of adverse reactions (sensitization or irritation) in human subjects and the results of cytotoxicity tests.

7. The sample size for the training set:

   • This question is not applicable to the device described. The Actiprotect™ UF N95 Respirator is a physical medical device, not a machine learning algorithm that requires a "training set" of data.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this type of device.

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Actiprotect™ UF 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 (2009 pandemic strains not tested)) within one minute of contact with the surface of the respirator. In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer layer when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, 2009 pandemic strains not tested), H2N2 (A2JJP/305/57), H3N2 (Hong Kong 8/68) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and an Influenza B strain (JPN/85/2007)) under tested contact conditions. Correlation between in vitro activity and any clinical event has not been tested. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Actiprotect™ UF 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 clastic strips are stapled or welded to the edge of the respirator and are used to secure the mask to the user's face.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Study that proves the device meets the acceptance criteria:

The document describes a series of nonclinical bench tests and clinical (biocompatibility) tests.

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

• Fluid Penetration Resistance, Particulate Filtration Efficiency, BFE, VFE, Flammability, Breathing Resistance: The document states "standardized tests" were performed and the device "passed." Specific sample sizes for these tests are not provided in the document. The data provenance is implied to be from laboratory testing as part of the device's manufacturing and regulatory submission. No specific country of origin for this testing data is explicitly stated, though the manufacturer is based in France and the applicant in the USA.
• Biocompatibility (Cytotoxicity): The document states "cytotoxicity" testing was conducted. Specific sample sizes are not provided. The provenance is laboratory testing.
• Biocompatibility (Human Repeated Insult Patch Tests): The document states "Human Repeated Insult Patch Tests were conducted using samples of the respirator materials held under occlusive patches." Specific subject sample sizes are not provided. The provenance is clinical testing on human subjects.
• Influenza A Virus Inactivation (In vitro testing): The document states "In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer layer when tested in vitro against the following influenza viruses..." The number of samples/replicates for the in-vitro testing is not provided. The provenance is laboratory testing, in vitro.

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 and not provided in the document. The tests performed are primarily objective performance benchmarks (e.g., filtration efficiency, flammability, virus inactivation rates) or biocompatibility studies, which do not typically involve human experts establishing a "ground truth" in the way, for example, a diagnostic imaging study would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. As mentioned above, these are not studies that would typically require an adjudication method. Outcomes are generally based on pass/fail criteria against established standards.

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:

An MRMC comparative effectiveness study was not done. The device is an N95 respirator with a virucidal coating, not an AI-assisted diagnostic tool using human readers.

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

A standalone performance evaluation was done for the device itself against established physical, chemical, and biological performance criteria (e.g. filtration efficiency for particulates, bacteria, and viruses; fluid penetration; flammability; breathing resistance; virus inactivation). These tests are "algorithm only" in the sense that they measure the device's inherent performance without human interpretation as part of the primary measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for most of the performance tests (e.g., filtration, fluid resistance, flammability, breathing resistance) is defined by the standardized test methods and their predetermined pass/fail criteria. For the virus inactivation claims, the ground truth is established by in vitro laboratory assays rigorously measuring reduction in viral infectivity. For biocompatibility, the ground truth is established by absence of cytotoxic effects or adverse skin reactions according to established toxicology and dermatological assessment protocols.

8. The sample size for the training set:

There is no mention of a training set as this product is not a machine learning or AI-based device. The testing described is for the physical and biological performance of a medical device (respirator).

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

Not applicable, as there is no training set for this type of device.

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