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The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. Fluidshield* 3 Surgical Masks(s) and Fluidshield* 3 Procedure Face Mask(s) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM F2100 Level 3 (orange in color) Surgical and Procedure Mask(s). The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Masks family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops. A malleable nosepiece is placed within the bindings to conform around the wearer's nose. The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.

This document describes the FDA 510(k) clearance for several Fluidshield® 3 Surgical and Procedure Masks. However, it does not contain the level of detail regarding study design, sample sizes, ground truth establishment, or expert qualifications that would be present in a comprehensive study report for an AI/software device. The information provided is typical for a medical device clearance describing performance characteristics and compliance with standards, not for an AI comparative effectiveness or standalone study.

Based on the provided text, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Based on available information in the document)

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

   • Sample Size: Not specified in the provided document. The document lists "Pass" for various tests, but does not detail the number of masks or samples tested for each criterion.
   • Data Provenance: Not specified. The tests are non-clinical (laboratory-based) tests of the physical properties and performance of the mask materials and construction. They are not based on patient data, but rather on material testing.

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

   • Not applicable as this is not an AI/software device study involving expert interpretation of data. The "ground truth" here refers to the quantitative results of standardized non-clinical material performance tests, performed by laboratory personnel according to the specified ASTM and ISO standards.

4. Adjudication method for the test set:

   • Not applicable. The performance is measured against objective, standardized physical testing methods rather than subjective expert consensus 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:

   • Not applicable. This document is for the premarket notification (510(k)) of physical medical devices (surgical masks), not an AI/software as a medical device (SaMD). Therefore, no MRMC study or AI performance evaluation was conducted.

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

   • Not applicable. This is not an AI/software device.

7. The type of ground truth used:

   • The "ground truth" for the performance claims of these masks is based on standardized non-clinical laboratory testing results as defined by the ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards listed (e.g., ASTM F2100, ASTM F2101, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993). These are objective, measurable physical properties and biocompatibility assessments.

8. The sample size for the training set:

   • Not applicable. This is not an AI/software device and therefore does not involve training sets.

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

   • Not applicable. No training set is involved.

Summary of the Study:

The "study" referenced in this document is a series of non-clinical laboratory tests to demonstrate that the Fluidshield® 3 Surgical and Procedure Masks meet established performance standards for medical face masks, specifically ASTM F2100 Level 3. These tests evaluate properties such as bacterial filtration efficiency, particulate filtration efficiency, differential pressure (breathability), fluid resistance, flammability, and biocompatibility (cytotoxicity, sensitization, irritation).

The conclusion states that the nonclinical tests demonstrate the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, forming the basis for its 510(k) clearance for market.

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The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM F2100 Level 1 (white in color) Procedure and Surgical Mask(s). The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Mask(s) are provided with earloops. A malleable nosepiece is placed within the bindings. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family will be provided in designs with and without a protective visor. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family are single use, disposable devices, provided non-sterile.

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:

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

The document describes non-clinical performance testing. For these types of tests, specific "test sets" of data provenance like country of origin or retrospective/prospective often don't apply in the same way they would for clinical studies. The tests are typically performed on samples of the manufactured device. The document does not specify the exact number of samples used for each test.

3. 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 these performance tests is established by standardized testing protocols and measurement methodologies, not expert consensus. These are objective measurements of material properties.

4. Adjudication method for the test set:

Not applicable. The tests involve objective measurements against predefined acceptance criteria, not subjective interpretation 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:

Not applicable. This is not an AI-powered device or a diagnostic device that would involve human readers. The device is a surgical mask.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:

The ground truth used for these tests is based on standardized test methods and calibrated equipment. For example:

• Bacterial Filtration Efficiency (BFE): Measured using ASTM F2101, which involves generating a biological aerosol and quantifying bacterial penetration. The "ground truth" is the scientific measurement of the filtration efficiency.
• Fluid Resistance: Measured using ASTM F1862, which involves propelling synthetic blood at a known pressure. The "ground truth" is the measured penetration.
• Biocompatibility (Cytotoxicity, Sensitization, Irritation): Evaluated against recognized biological safety standards (ISO 10993) where "non-cytotoxic," "non-sensitizing," and "non-irritant" are the ground truths determined by the specific test methodologies.

8. The sample size for the training set:

Not applicable. This device is a physical medical device (surgical mask) and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable. There is no training set for this device.

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The FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.

The subject devices are ASTM F2100 Level 1 (lavender in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) includes a malleable nosepiece. The FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) includes a visor and nose foam. These masks are single use, disposable devices, provided non-sterile.

The provided document is a 510(k) summary for a medical device (face masks) and describes non-clinical performance testing against established standards, not a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested information regarding AI acceptance criteria, training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the non-clinical testing summary as requested:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each test. The tests are non-clinical (e.g., material testing, not patient data). The provenance is not explicitly stated beyond being conducted for a US FDA 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. These are non-clinical performance tests against established standards (ASTM, ISO, EN), not diagnostic studies requiring expert human review to establish ground truth.

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

Not applicable. This is not a study involving human readers or subjective interpretations that would require 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

Not applicable. This is not an AI-assisted diagnostic device; it is a physical medical device (face mask).

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for these tests is defined by the specific performance and safety standards (e.g., ASTM F2101 for bacterial filtration efficiency, ISO 10993 for biocompatibility). The device's performance is compared directly against the quantitative or qualitative criteria set by these standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) are single use, disposable device(s), provided non-sterile.

The subject device(s) are ASTM Level 1 (blue in color) Surgical and Procedure Mask(s). The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are a three-layer mask, constructed of non-woven materials. The Surgical Masks (28802) are provided with ties while the Procedure Masks (25869) are provided with earloops. A malleable nosepiece is placed within the bindings to conform with the wearer's nose. The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are single use, disposable devices, provided non-sterile.

The provided document is a 510(k) Premarket Notification for a medical device (surgical masks), not for an AI/software device. Therefore, the information requested regarding acceptance criteria, study design, ground truth establishment, and expert involvement for a software/AI device is not applicable and cannot be extracted from this document.

The document describes the non-clinical performance testing for surgical masks, which focuses on physical and biological properties rather than AI algorithm performance.

Here's an analysis of the provided information, specifically addressing the non-AI device context:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the exact sample sizes used for each of these non-clinical performance tests. These are standard laboratory tests typically performed on a statistically relevant number of samples to ensure representativeness. The provenance (country of origin, retrospective/prospective) is not detailed for these laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This is not applicable to the performance testing of surgical masks. Ground truth, in the context of material and product performance, is established by adherence to standardized testing protocols (e.g., ASTM, ISO, EN) and validated laboratory methods, not by expert consensus or interpretations of complex data like medical images.

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

Not applicable. These are objective, quantitative laboratory tests with defined pass/fail criteria, not subjective assessments requiring expert 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:

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI-assisted device.

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

The "ground truth" for these tests is the objective measurement against established performance standards (e.g., specific filtration percentages, pressure differentials, flame spread classes), as defined by the international standards mentioned (ASTM, EN, ISO, CFR).

8. The sample size for the training set:

Not applicable. There is no training set for a non-AI medical device like a surgical mask.

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

Not applicable. There is no training set for a non-AI medical device.

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The Fluidshield* 2 Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Fluidshield* 2 Surgical Mask is a single use, disposable device, provided non-sterile.

The Fluidshield* 2 Procedure Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Fluidshield* 2 Procedure Mask is a single use, disposable device, provided non-sterile.

The subject device(s) are ASTM Level 2 Surgical and Procedure Mask(s). Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops and a malleable nosepiece.

The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.

The provided document is a 510(k) Premarket Notification for medical devices, specifically surgical and procedure masks. It describes non-clinical performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria derived from clinical performance. Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable or cannot be extracted from this document as it pertains to a different type of evaluation.

However, I can extract information related to the acceptance criteria and reported device performance from the non-clinical testing section.

1. Table of acceptance criteria and the reported device performance:

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

• Sample size used for the test set: Not specified in the provided document. The document refers to "testing" the proposed device(s) but does not detail the number of units or samples tested for each criteria.
• Data provenance: Not explicitly stated, but these are non-clinical (laboratory) tests performed on the device by the manufacturer as part of the 510(k) submission process. It's retrospective in the sense that the testing was completed before the submission.

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

• Not applicable. This document describes non-clinical performance testing against established standards, not a study involving expert-established ground truth for a diagnostic device.

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

• Not applicable. This pertains to expert review for diagnostic studies, not laboratory performance testing of physical characteristics.

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:

• Not applicable. This is a 510(k) submission for surgical and procedure masks, not an AI-assisted diagnostic device.

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

• Not applicable. This is a 510(k) submission for surgical and procedure masks, not an algorithm.

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

• For the non-clinical tests, the "ground truth" is defined by the established international and national standards (e.g., ASTM F2100, ASTM F2101, EN 14683, ISO 10993 series). The device's performance is measured against the quantitative or qualitative criteria set forth in these standards.

8. The sample size for the training set:

• Not applicable. This document describes material and physical performance testing of a physical device, not a machine learning algorithm that requires a training set.

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

• Not applicable for the same reason as above.

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The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are single use, disposable device(s), provided non-sterile.

The subject devices are ASTM F2100 Level 1 (yellow in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Procedure Masks are provided with earloops and a malleable nosepiece. The ASTM F2100 Level 1 Procedure Masks that are the subject of this submission are not provided with a fog-free foam or visor. These masks are single use, disposable devices, provided non-sterile.

The provided text describes a 510(k) premarket notification for two medical masks, HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) and HALYARD* Level 1 Procedure Mask (48388). This document is a regulatory filing demonstrating "substantial equivalence" to a legally marketed predicate device, the Kimberly-Clark KC100 Face Masks (K110455).

The information provided does not pertain to an AI/ML-driven device or a comparative effectiveness study involving human readers with and without AI assistance. Instead, it details the performance characteristics and safety of physical medical masks based on standardized non-clinical tests. Therefore, many of the requested criteria regarding AI device studies cannot be answered from this document.

However, I can extract information related to the acceptance criteria and the non-clinical study performed for these masks.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document provides a "Technological Characteristics Comparison Table" and a "Summary of Non-Clinical Testing." These tables effectively outline the acceptance criteria (as defined by the predicate device's performance and relevant ASTM/ISO standards) and the results for the subject devices.

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

The document refers to non-clinical tests (e.g., ASTM F2101, ASTM F1862). For these types of standardized tests, samples are drawn from production lots. The document does not specify the exact sample sizes used for each test. The data provenance is implied to be from the manufacturer's own testing as part of their regulatory submission, likely conducted in certified labs. There is no mention of country of origin of the data beyond the manufacturer's location (Mechanicsville, Virginia, USA). The studies are not retrospective or prospective in the sense of clinical imaging studies; they are laboratory-based performance and safety evaluations.

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

This question is not applicable to this type of device and study. The "ground truth" for mask performance and safety is established by adherence to recognized international standards (e.g., ASTM, ISO, CFR), not by expert consensus on complex imaging data. The tests are objective measurements of physical and biological properties.

4. Adjudication method for the test set:

Not applicable. There is no subjective interpretation requiring adjudication. Results are based on objective pass/fail criteria defined by the 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:

Not applicable. This is not an AI/ML-driven device.

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

Not applicable. This is not an AI/ML-driven device.

7. The type of ground truth used:

The "ground truth" for the performance claims of these medical masks is established through adherence to recognized performance standards and regulations (e.g., ASTM F2101, ASTM F1862, 16 CFR 1610, ISO 10993 series). This involves objective measurements obtained in laboratory settings.

8. The sample size for the training set:

Not applicable. There is no AI/ML model for which a training set would be used.

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

Not applicable, as there is no training set.

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HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is a single use, disposable device, provided non-sterile.

The subject device is an ASTM F2100 Level 1 (green in color) Surgical Mask. The ASTM F2100 Level 1 Surgical Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties and a malleable nosepiece. The HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is provided with fog-free foam. These masks are single use, disposable devices, provided non-sterile.

This information describes the performance testing for a medical device (a surgical mask), not an AI/ML device. Therefore, many of the requested criteria regarding AI/ML studies are not applicable.

Here's the breakdown of the provided information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each test. The tests are non-clinical performance tests on the physical mask, not data-driven tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. These are physical performance tests that follow standardized test methods, not expert-adjudicated ground truth for AI/ML performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring adjudication of results.

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
Not applicable. This is a surgical mask, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests is defined by the specific, recognized international and national standards (ASTM, EN, ISO, 16 CFR Part 1610) that outline the methodologies and acceptance criteria for evaluating the physical and biological properties of surgical masks.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.

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Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from microorganism transfer, body fluids, and particulate matter. The gowns are non-sterile, single use, and meet AAMI PB70:2012 level 3 Liquid Barrier performance requirements. Not intended for use in the operating room.

The Halyard Tri-Layer AAMI 3 Isolation Gown ("Isolation Gown") is a single use gown, supplied non-sterile. The gowns come in the following sizes: Large, X-Large. These surgical gowns are apparel that are intended to be worn by healthcare professionals to protect from varying levels of fluid contact (low to moderate). These surgical gowns meet the AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, Level 3 Requirements. These Isolation Gowns are manufactured from three-layer full length polypropylene SMS material, with neck tape, elastic cuffs, and waist belt closure systems.

The provided document details the non-clinical testing performed on the Halyard Tri-Layer AAMI 3 Isolation Gowns to demonstrate their substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

The sample sizes for the test sets are indicated for each test in the acceptance criteria table. For example, for Spray Impact (AATCC 42) and Hydrostatic Pressure (AATCC 127), the sample size is n=35 with c=3. For Static Decay (STM-00180), the sample size is n=36 with c=0. For Grab Strength and Tear Strength (ASTM D5034, D5733, D1683), the sample size is n=24 for a one-sided 95/95 tolerance limit. For Flammability (CFR 1610), the sample size is n=49 with c=0. For Lint Generation (EN ISO 9073-10), the sample size is n=30.

The document does not specify the country of origin of the data or whether the data is retrospective or prospective.

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

Not applicable. This is a submission for an isolation gown, and the testing involves laboratory measurements against established physical and material standards, not expert clinical evaluation for a diagnostic or AI device.

4. Adjudication Method for the Test Set:

Not applicable. The tests are laboratory-based and measure physical properties against defined 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:

Not applicable. This is not an AI-enabled device.

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

Not applicable. This is not an AI-enabled device.

7. The Type of Ground Truth Used:

The "ground truth" for the performance of the isolation gowns is based on established industry and international standards for protective apparel (e.g., AAMI PB70:2012, AATCC, ASTM, ISO standards). The device's physical and material properties are directly measured and compared against the predefined acceptance criteria within these standards.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable. There is no training set as this is not an AI/machine learning algorithm.

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The HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

Respirator consisting of nonwoven inner facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece

The provided text is a 510(k) Summary for a medical device (HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family). It describes the device, its intended use, and its performance against pre-defined acceptance criteria through non-clinical testing. It does not involve any clinical studies, expert-based ground truth, or MRMC comparative effectiveness studies as it's a device clearance for a respirator mask, not an AI/software-based medical device.

Therefore, many of the requested elements are "Not Applicable" (NA) for this type of submission.

Here's the information extracted from the text:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the exact sample sizes used for each non-clinical test (e.g., number of masks tested for filtration efficiency or breathability). The testing is non-clinical bench testing, not involving human subjects or clinical data in the traditional sense. Data provenance is not specified but is typically internal lab testing by the manufacturer or contracted labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is for a physical medical device (respirator mask) and involves non-clinical bench testing, not expert-based ground truth from medical professionals.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical medical device (respirator mask) and involves non-clinical bench testing, not expert 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:
Not applicable. This is for a physical medical device (respirator mask), not an AI/software-based device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for a physical medical device (respirator mask), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" here refers to established technical standards and test methods (e.g., NIOSH certification requirements for filtration, ASTM F1862 for fluid resistance, ISO 10993 standards for biocompatibility). The device's performance is compared against these objective criteria rather than expert consensus or pathology.

8. The sample size for the training set:
Not applicable. This is for a physical medical device (respirator mask). The concept of a "training set" is not relevant here as there is no algorithm being trained.

9. How the ground truth for the training set was established:
Not applicable. There is no training set for a physical respirator mask.

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The Expanded Chamber Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber that are the subject of this submission are provided with a visor (39124). These masks are single use, disposable devices, provided non-sterile.

The subject devices, the HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124), are the same devices as cleared under K143287.

The subject devices are ASTM F2100 Level 2 (blue and white in color) Surgical Masks. The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) are a four- layer mask, constructed of well-known non-woven materials used in facial protection. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. When compared to a pleated/flat mask, the subject devices have a "duckbill" shape, which expands the volume of the chamber created when the mask is worn.

The provided text is a 510(k) Summary for a medical device (surgical masks). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing. It does not typically contain information about AI/ML models, human reader studies, or detailed ground truth methodologies used in the context of advanced diagnostic or imaging AI.

Therefore, many of the requested points related to AI/ML device studies are not applicable to this document.

Here's the information that can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify exact sample sizes for each non-clinical test (e.g., number of masks tested for BFE, PFE, etc.). It describes non-clinical performance testing against established standards (ASTM, EN, ISO). Data provenance (country of origin, retrospective/prospective) is not mentioned as these are laboratory-based material performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These are non-clinical material performance tests, not studies requiring expert interpretation of medical data (like radiology images). The ground truth is defined by the technical specifications and outcomes of the standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML or diagnostic study requiring expert adjudication of interpretations.

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:
Not applicable. This is for a surgical mask, not an AI-assisted diagnostic device. No "human readers" or "AI assistance" are involved in its performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is for a surgical mask, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the non-clinical tests is based on the specific methodologies and pass/fail criteria defined by the international and national standards cited (e.g., ASTM F2101 for Bacterial Filtration Efficiency, ISO 10993 for biocompatibility). The tests objectively measure physical and biological properties against quantifiable benchmarks.

8. The sample size for the training set:
Not applicable. This device is not an AI/ML product developed with a training set.

9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML product.

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