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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.

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.

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This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies - Pasture™ A520G Respirator and Pasture™ F550G Respirator

Pasture F550G respirator is a duck bill mask as described in NIOSH N95 standard It 1s in 5 layers and composed of spunbond, meltblown and polyester, also with nose cushion, elastic loops and/or strip and nosepiece which is the combination of zinc wires and embedded polyester inside of layers

Pasture A520G respirator is a cone shaped mask as described in NIOSH N95 standard It is in 4 layers and composed of spunbond, meltblown and polyester, also with synthetic rubber band which is coated with polyester and free of latex

The provided text describes a 510(k) summary for Filtering Facepiece Respirators (Pasture™ F550G & A520G). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria, sample sizes, and expert evaluations as would be expected for a diagnostic or AI-driven device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test/training sets, training set size) are not applicable or not available in this type of submission. This 510(k) is for a physical device (respirator), and the "performance" discussed is related to its physical properties and NIOSH certification, not an AI algorithm.

Here's the information that can be extracted or derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are typically the requirements for NIOSH certification and meeting the performance of the predicate device. The document primarily relies on comparative testing to the predicate device and NIOSH certification.

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

• Sample Size: Not specified in the 510(k) summary. For physical products like respirators, testing typically involves a sufficient number of units to demonstrate consistent performance against standards (e.g., NIOSH testing protocols would define sample sizes for particle filtration, breathability, fit, etc.). However, these specific numbers are not provided here.
• Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. The testing would have been conducted to support the NIOSH certification and biocompatibility claims. This is prospective testing specifically for the device submission.

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

• Not Applicable. This is a physical device (respirator), not an AI diagnostic. "Ground truth" in the context of diagnostic performance by experts is not relevant here. Performance is assessed against physical and biochemical standards.

4. Adjudication Method for the Test Set

• Not Applicable. As above, no expert adjudication is involved for physical performance testing of a respirator.

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

• No. This is not an AI diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. There is no algorithm. The device itself is the "standalone" product.

7. The Type of Ground Truth Used

• Physical/Chemical Standards: The "ground truth" for a respirator's performance is established by standardized testing methods defined by bodies like NIOSH (e.g., particle filtration efficiency, breathing resistance, fit testing protocols) and biocompatibility standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation). The predicate device's performance also acts as a reference for substantial equivalence.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. No training set is involved.

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