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The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator, and inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.

In vitro tests have demonstrated 99.99% inactivation on the surface of the mask when tested against the following seasonal, pandemic, avian, swine influenza viruses: Influenza A subtypes: H1N1 (A/ California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/ Lee/40.

No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator.

The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.

The SpectraShield model 9500 Surgical Mask is a molded shape surgical mask composed of 4 layers of material, molded to form the mask. A 2-ply meltblown polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include fibers that have been embedded with an antibacterial/antiviral agent to provide antibacterial and antiviral performance. The mask has 2 elastic straps (not made with natural latex) and an aluminum nose strip.

The provided document is a 510(k) Summary for the SpectraShield Model 9500 Surgical Mask, describing its characteristics and comparing it to predicate devices to demonstrate substantial equivalence. It does not describe an AI medical device. Therefore, it is not possible to answer the request by extracting information about acceptance criteria for an AI device.

However, I can extract the acceptance criteria and performance data for the surgical mask as presented in the document, which are based on standard tests for such devices.

Here's the information regarding the SpectraShield Model 9500 Surgical Mask, formatted as requested for an "AI device," but adapted to fit the context of a physical medical device (surgical mask):

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test. However, it indicates that the tests performed are in vitro (laboratory) tests. Data provenance is not explicitly stated beyond "in vitro (laboratory) tests," implying laboratory settings and not human clinical data or geographical origin. The study is a pre-market notification (510k) using performance data to demonstrate substantial equivalence to predicate devices, not a clinical study on patient outcomes.

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

This is not applicable as the tests described are in vitro laboratory tests measuring physical and microbiological properties of the mask, not evaluations requiring expert interpretation of medical images or patient data to establish ground truth.

4. Adjudication method for the test set

This is not applicable as the tests are objective laboratory measurements, not subjective evaluations requiring adjudication.

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 is not applicable. The device is a surgical mask, not an AI diagnostic or assistive tool.

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

This is not applicable. The device is a surgical mask, not an AI algorithm. The performance data presented are for the mask itself in laboratory settings.

7. The type of ground truth used

For the physical and biological tests (fluid resistance, filtration, pressure, flammability, cytotoxicity, skin irritation, systemic toxicity, physico-chemical, gas/leach-off), the "ground truth" is defined by the objective measurement adhering to established ASTM, Mil, CFR, ISO, and USP standards.

For bacterial and viral reduction, the "ground truth" is the quantitative reduction in viable microorganisms as measured in the in vitro laboratory tests.

8. The sample size for the training set

This is not applicable. The device is a physical product (surgical mask), not an AI model that requires a training set.

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

This is not applicable, as there is no AI training set involved. The product's characteristics are inherent to its design and manufacturing.

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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 SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgical N95 respirator, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.

No clinical studies have been conducted comparing the ability of an untreated surgical N95 respirator and the SpectraShield model 9500 surgical N95 respirator to protect the wearer from infection, and the antibacterial treatment cannot effect pathogens that are inhaled around the edges of the respirator.

The SpectraShield 9500 Surgical N95 respirator is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.

The SpectraShield model 9500 Surgical Mask is a molded shape surgical mask composed of 4 layers of material, molded to form the mask. A 2-ply meitblown polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include fibers that have been embedded with an antibacterial agent to provide antibacterial performance. The mask has 2 latex-free non-allergenic elastic straps and an aluminum nose strip.

The SpectraShield 9500 Surgical N95 Respirator, as described in K120244, demonstrates its performance through a series of laboratory-based tests comparing it to a predicate device (K090414). The primary goal of this 510(k) submission was to amend the Intended Use Statement of the SpectraShield 9500 Surgical N95 Respirator to include "tested for continuous use up to 8 hours," based on existing bioefficacy data showing sustained performance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by meeting or exceeding the performance of the predicate device (K090414) in various standardized tests. The new device is essentially the same as the predicate, with the requested change being an update to the Intended Use Statement.

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample sizes used for each specific test in the "test set" in terms of number of masks. Instead, it references standardized ASTM, Mil, ISO, and USP test methods, which typically define their own sample size requirements. The data provenance is described as "in vitro (laboratory) tests," indicating that the tests were conducted in a controlled lab environment. There is no information about country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

This type of submission (510(k) for a surgical mask with an amended intended use) relies on objective, repeatable physical and biological performance tests, not human expert interpretation of results for ground truth. Therefore, there were no "experts" in the traditional sense (e.g., radiologists) used to establish ground truth for a test set. The ground truth for performance measures (e.g., filtration efficiency, bacterial kill) is based on the results of the specified laboratory tests performed according to recognized standards.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is described or applicable, as the evaluation of this device is based on quantifiable laboratory test results against predefined standards, not on subjective human assessments that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There was no MRMC comparative effectiveness study done. The device is a surgical mask, and its performance is evaluated through material science and microbiology testing rather than clinical interpretation by human readers. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable.

6. Standalone Performance (Algorithm Only)

A standalone performance evaluation was conducted for various physical and biological parameters of the mask. The "algorithm only" concept does not apply here as the device is a physical product (a mask), not an AI algorithm. The performance metrics presented in the table above represent the standalone performance of the device without human-in-the-loop for the core functionalities tested.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance is based on objective laboratory test results according to established national and international standards (e.g., ASTM, Mil, ISO, USP). For bioefficacy, the ground truth is the measured bacterial reduction percentage based on controlled in vitro bacterial challenges. No pathology or outcomes data is mentioned in this summary for establishing ground truth.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI, as this device submission is for a physical medical device. The tests performed are part of a product validation rather than an AI model development.

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

As there is no "training set" in the context of this traditional medical device submission, the concept of establishing ground truth for a training set is not applicable.

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The SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgical N95 respirator, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.

No clinical studies have been conducted comparing the ability of an untreated surgical N95 respirator and the SpectraShield model 9500 surgical N95 respirator to protect the wearer from infection, and the antibacterial treatment cannot effect pathogens that are inhaled around the edges of the respirator.

The SpectraShield 9500 Surgical N95 respirator is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material,

The SpectraShield model 9500 Surgical Respirator is a molded shape surgical respirator composed of 4 layers of material, molded to form the respirator. A 2-ply meltblown polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include fibers that have been embedded with an antimicrobial agent to provide antimicrobial performance. The respirator has 2 latex-free non-allergenic elastic straps and an aluminum nose strip.

Here's an analysis of the acceptance criteria and study information for the SpectraShield model 9500 Surgical Respirator based on the provided text:

Device: SpectraShield model 9500 Surgical Respirator

1. Table of Acceptance Criteria and Reported Device Performance:

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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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