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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 N95 Particulate Respirator (MF01) is single-use, disposable device, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

The N95 particulate respirator (Model MF-01) is NIOSH certified (TC-84A-7697), pouched-shaped respirators when worn. The flat-folded respirator is composed of four layers-inner layer, filter (2 layers) and outer layer. The four layers are combined via ultrasonically welded. The respirator also contains a nose-piece enclosed in a binding tape welding the top edge to conform to the contours of the face. The respirator contains straps to secure the respirator in place on the wearer. The respirator is offered in white. The respirator is provided non-sterile and for single use only.

This document is a 510(k) Premarket Notification for a Master-Frank N95 Particulate Respirator. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of diagnostic AI. Thus, much of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types for AI models) is not applicable or present in this document.

However, I can extract the acceptance criteria and reported device performance from the "Non-Clinical Performance Data" and "Performance testing" sections, which are focused on the physical performance and biocompatibility of the respirator.

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 of the biocompatibility and physical performance tests. It refers to established standards (e.g., ISO 10993, ASTM F1862, 16 CFR 1610, NIOSH certification), which would have their own specified sample sizes. The data provenance is from tests conducted on the Master-Frank N95 Particulate Respirator (Model MF-01) by accredited labs for NIOSH certification and other standards. The document doesn't specify the country of origin of the testing data itself, but the manufacturer is based in China. The data is prospective as it pertains to the device being submitted for clearance.

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

Not applicable in the context of this device clearance. The "ground truth" for these tests is defined by the objective measurement criteria within the specified international standards and NIOSH certification protocols. These tests are conducted by trained technicians in certified laboratories, following stringent procedures rather than subjective expert interpretation.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, quantitative measurements following standardized protocols (e.g., measuring filter efficiency, fluid penetration, flame spread). There is no "adjudication" in the sense of reconciling differing expert opinions. The results are either "pass" or "fail" against defined thresholds.

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 clearance of an N95 particulate respirator, not an AI-powered diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was performed or reported.

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

Not applicable. This device is a physical respirator, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance claims of the N95 respirator is based on objective, standardized physical and biocompatibility testing criteria. Examples include:

• Physical Measurements: Filtration efficiency (% of particles filtered), differential pressure (airflow resistance), fluid penetration (absence of synthetic blood penetration at a given pressure), and flame spread time.
• Biocompatibility Assessments: Observational and analytical results from in vitro cytotoxicity assays, irritation tests (e.g., skin irritation), and sensitization tests (e.g., skin sensitization) performed according to ISO 10993 standards.

These are verifiable, objective measures against international standards and regulatory requirements.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device. The device is a physical product designed and manufactured to meet specific performance standards.

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

Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for a training set does not apply here. The device's performance is established through direct physical and biological testing against predefined standards.

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3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1804/1804S is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S are provided as a flat-folded Surgical N95 Respirator composed of multi layers of materials consisting of polypropylene spunbond (inner web), polypropylene (filter web), polypropylene spunbond (outer web). The product contains an aluminum nose clip within the layers of the top edge of the product to conform to the contours of the face. In addition, the product contains two steel staples used to secure the two polyisoprene elastic headbands (not made with natural rubber latex) to the product and the headbands are to secure the product in place on the wearer. The products are provided only in white and provided in two sizes one being small.

The 3MM VFlex™ Health Care Particulate Respirator and Surgical Mask, 1804/1804S is an particulate respirator. Particulate respirators help reduce the wearer exposure to certain airborne particles. including those generated by electrocautery, laser surgery and other powered medical instruments. This respirator has a filter efficiency level of at least 95% against particulate aerosols free of oilt. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials and meets >99% bacterial filtration efficiency (BFE) ±. It is cleared to be worn in surgery. It can fit a wide range of face sizes. CDC guidelines state N95 respirators may be used for M. tuberculosis. *

This document is a 510(k) Premarket Notification for a medical device: 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870).

The provided text describes the device, its intended use, and a comparison to a predicate device based on various features and performance specifications. However, this document does not describe a study involving an AI/Machine Learning device, human readers, or image analysis for medical diagnosis. It details the acceptance criteria and performance data for a physical product, specifically a surgical mask/respirator.

Therefore, many of the questions regarding AI/ML study design (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training) are not applicable to this type of device submission.

Here's a breakdown of the information that is relevant to the provided text, structured as requested where possible:

Acceptance Criteria and Device Performance for a Surgical Mask/Respirator:

Study Proving Device Meets Acceptance Criteria:

The document describes pre-market testing and comparison to a predicate device, not a "study" in the typical sense of a clinical trial or AI model validation. The "proof" relies on adherence to recognized standards and certifications.

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

   • Sample Size: Not explicitly stated as a "sample size" in the context of subject recruitment. The tests are conducted on manufactured products. The number of masks/respirators tested for each performance metric (e.g., fluid resistance, BFE, PFE, flammability) is not specified in this summary, but would adhere to the sample size requirements defined by the respective ASTM, NIOSH, or CFR standards.
   • Data Provenance: The tests are standard performance evaluations for the device, likely conducted by the manufacturer (3M Health Care) or certified laboratories. The information does not specify the country of origin of testing, nor does it distinguish between retrospective or prospective data generation, as it pertains to product performance testing rather than patient data.

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

   • Not applicable. "Ground truth" in this context refers to the defined performance standards (e.g., ASTM F1862 for fluid resistance) and the physical properties of the device, measured by laboratory equipment, rather than expert interpretation of medical images or clinical outcomes.

3. Adjudication method:

   • Not applicable, as there are no human interpretations or disagreements that require adjudication. Performance metrics are objectively measured against established standards.

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

   • No. This is a physical product (respirator/mask), not an AI-assisted diagnostic tool.

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

   • No. This is a physical product.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is based on recognized industry standards and laboratory test methods (e.g., NIOSH certification for PFE and differential pressure, ASTM F1862 for fluid resistance, ASTM F2101 for BFE, 16 CFR 1610 for flammability, and ISO 10993-1 for biocompatibility). These standards define the acceptable range or threshold for a product to be considered effective and safe for its intended use.

7. The sample size for the training set:

   • Not applicable. This is not an AI/Machine Learning device that requires a training set.

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

   • Not applicable.

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The N95 Particulate Respirator and Surgical Mask, Models TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

The N95 Particulate Respirator and Surgical Mask, Models #TN01-11 and #TN01-12 are NIOSH certified (TC 84A-3348), pouchedshaped respirators when worn. The flat-folded masks are composed of four layers of materials consisting of polypropylene and polyethylene (inner layer), polypropylene meltblown (two filter layers), and polypropylene spunbond (outer layer). The masks contain a conformable nose clamp enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, polyurethane elastic headband not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in orange or white.

The provided document describes the acceptance criteria and performance of the N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12, in comparison to a predicate device.

Here's a breakdown of the requested 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 explicitly state the specific sample sizes used for each performance test (e.g., number of masks tested for fluid resistance or flammability). It simply states that the models meet the requirements of the standards. The provenance of the data is not specified beyond indicating it was a submission to the FDA. The tests are described as performance testing and non-clinical tests, which are typically prospective.

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 information is not applicable to the type of device and testing described. The "ground truth" for N95 masks is established through standardized laboratory performance tests according to recognized standards (e.g., ASTM, NIOSH, ISO) and not through expert consensus or interpretation of medical images.

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

This information is not applicable. Adjudication methods like 2+1 are typically used in studies where human readers interpret medical data (e.g., radiology studies) and their findings need to be reconciled. For performance testing of a physical device like an N95 mask, objective laboratory measurements are taken against predefined criteria.

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 information is not applicable. The device is a physical N95 mask, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this document.

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

This information is not applicable. The device is a physical N95 mask; there is no algorithm or AI component involved. The testing described is for the physical performance of the mask.

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

The ground truth for the performance of the N95 mask is based on objective measurements against established performance standards set by regulatory bodies and testing organizations. These include:

• ASTM F1862 for Fluid Resistance
• NIOSH Certification (TC 84A-3348) for Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure
• 16 CFR 1610 for Flammability
• ISO 10993 series for Biocompatibility (cytotoxicity, irritation, sensitization)

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of performance testing for a physical medical device like an N95 mask. Training sets are relevant for machine learning or AI models.

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

This information is not applicable, as there is no training set for this type of device and study.

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Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS is a NIOSH certified N95 respirator, and is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

Pasture F550S and Pasture F550CS respirators are disposable duck bill shaped N95 respirators with NIOSH certification number TC-84A-7504. They contain 5 layers composed of polypropylene, with a nose cushion, a synthetic elastic loop or strap, and a nosepiece which is the combination of zinc wires and embedded polyester inside of layers. F550CS is the same respirator as the F550S, but F550CS contains an adjustable buckle on the headband.

Pasture A520S and Pasture A520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7454. They contain 4 layers composed of polypropylene with a synthetic elastic loop or a strap. A520CS is the same respirator as the A520S, but A520CS contains an adjustable buckle on the headband.

Pasture E520S and Pasture E520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7453. They contain 4 layers composed of polypropylene with a nose cushion, synthetic elastic loop or strap, and an aluminum nosepiece. E520CS is the same respirator as E520S, but E520CS contains an adjustable buckle on the headband.

This document describes the premarket notification for several models of Pasture Surgical N95 Respirators (F550S, F550CS, A520S, A520CS, E520S, E520CS). The provided information is insufficient to answer all parts of the request as it pertains to medical device AI/ML performance studies. However, I can extract the relevant information from the document regarding the acceptance criteria and performance of these N95 respirators. The questions asked are typically for AI/ML devices, not for surgical respirators.

Here's an analysis based on the provided text, adapted to the context of a physical medical device (N95 respirator) and its regulatory submission.

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

The acceptance criteria for these N95 respirators are based on various performance standards and regulatory requirements for surgical masks and N95 respirators. The document primarily demonstrates substantial equivalence to a predicate device (WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095) through performance testing.

The following questions are not applicable to the provided document, as it concerns a physical medical device (N95 respirator) and not an AI/ML algorithm or software as a medical device (SaMD). The document does not describe a study involving readers, ground truth establishment by experts, or training/test sets in the context of an AI/ML device.

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

• Not Applicable. This document describes a 510(k) premarket notification for physical N95 respirators, not an AI/ML device or its test set. Performance testing is typically conducted on a sample of manufactured devices according to established test methods for physical properties and biocompatibility. The specific sample sizes for each test (e.g., fluid resistance, flammability) are not detailed in this summary but would be specified in the full test reports referenced by the NIOSH certification and ASTM standards. The provenance of the data would be from the laboratories that performed these physical 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. Ground truth in the context of expert consensus is relevant for diagnostic AI/ML algorithms. For N95 respirators, the "ground truth" is determined by physical and chemical test results against a defined standard (e.g., NIOSH standards, ASTM F1862). Expert qualifications would pertain to the technicians conducting these standardized tests, ensuring they follow protocols, not to clinical interpretation of data.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML performance studies to resolve discrepancies in expert interpretations to establish a robust ground truth. For N95 respirators, performance is objectively measured by standardized tests, not by expert consensus on clinical findings.

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. MRMC studies are designed to assess the impact of AI assistance on human reader performance, typically in diagnostic imaging. This document does not pertain to an AI device.

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

• Not Applicable. This question relates to the performance of an AI algorithm in isolation. The product is a physical N95 respirator.

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

• For physical devices like N95 respirators, the "ground truth" for performance is defined by adherence to established industry standards and regulatory requirements (e.g., NIOSH N95 certification, ASTM F1862 for fluid resistance, 16 CFR 1610 for flammability, ISO 10993 for biocompatibility). The tests objectively measure specific characteristics.

8. The sample size for the training set

• Not Applicable. Training sets are used for machine learning algorithms. This document describes a hardware device.

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

• Not Applicable. As above, training sets are not relevant to this type of device.

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3M™ VFlex™Health Care Particulate Respirator and Surgical Mask 1805/1805S is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1805/1805S is an N95 particulate respirator. Particulate respirators help reduce wearer exposure to certain airborne particles, including those generated by electrocautery, laser surgery and other powered medical instruments. This respirator has a filter efficiency level of at least 95% against particulate aerosols free of oil . As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials+ and meets > 99% bacterial filtration efficiency (BFE) *. It is cleared to be worn in surgery. It can fit a wide range of face sizes. This respirator contains no components made from natural rubber latex.

The provided text is a 510(k) summary for the 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S. It describes the device and claims substantial equivalence to a predicate device (3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870) rather than presenting a study to prove a device meets specific acceptance criteria based on novel performance.

Therefore, the information required for the requested output (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone studies, ground truth types, and training set information) is not applicable to this document as it details a substantial equivalence claim for regulatory clearance, not a performance study against predefined acceptance criteria for a novel device or AI algorithm.

The document focuses on comparing the new device's characteristics and performance to those of a previously cleared predicate device to assert that there are "no new questions of safety or effectiveness."

However, I can extract the comparison table that shows the specifications and performance characteristics of both the subject device and the predicate device, which implicitly defines the "acceptance criteria" in the context of substantial equivalence.

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

In the context of a 510(k) substantial equivalence claim, the "acceptance criteria" are implied by the performance characteristics of the predicate device. The new device is considered to "meet acceptance criteria" if its performance is substantially equivalent to the predicate device, such that there are no new questions of safety or effectiveness.

*This is a common performance standard for all N95 respirators, specified in the description but implied as a meeting criterion for both predicate and subject.
**This is a common performance standard for surgical masks, specified in the description but implied as a meeting criterion for both predicate and subject.

Key conclusions from the document:

• The subject device (3M™ VFlex™ 1805/1805S) is substantially equivalent to the predicate device (3M™ 1870).
• Both devices are fluid resistant (though at different pressure levels: predicate at 160 mmHg, subject at 120 mmHg), classified as Class I for flammability, and NIOSH certified with N95 filtration efficiency.
• The differences in materials ("Stiffener web" and "Nose foam" present in predicate but "NA" for subject) and fluid resistance pressure threshold did not raise new questions of safety or effectiveness in the FDA's determination.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) summary for substantial equivalence, not a report of a clinical or performance study with a test set of data in the AI/medical device sense. The "tests" mentioned are standard industry tests for mask performance (e.g., NaCl load test, fluid resistance, flammability, NIOSH certification), which are typically done on samples of the manufactured product. Specific sample sizes for these manufacturing quality/performance tests are not detailed in this regulatory summary.

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. No ground truth establishment by experts for a test set is described, as this is not an AI/diagnostic device performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is described.

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.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth, in the context of AI or diagnostic device evaluation, is not relevant here. The "truth" for this device relates to meeting physical and performance specifications for filtration, fluid resistance, and flammability, tested by established laboratory methods.

8. The sample size for the training set
Not applicable. No training set is involved 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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The device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Barrier® N95 Particulate Respirators. Models #4273 are NIOSH certified (TC-84A-4350), trapezoid shaped respirators. Barrier® N95 Particulate Respirators, Models #4273 consists of a flat folded disposable face mask that is a piece of three layered non-woven fabric folded in two. An aluminum filament is enclosed in a binding tape welding the top edge, which forms a conformable nose clamp for the purpose of shaping the mask to the contours of the face. It features elastic head bands, ultrasonically welded, to secure the masks in place for the wearer.

Here's a breakdown of the acceptance criteria and the study information for the Barrier® N95 Particulate Respirators, Models #4272 and #4273, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by various standards and NIOSH certifications. The document states that the device "meets the requirements" of these standards and certifications.

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

The document does not explicitly state the sample size used for the test set for each characteristic. It refers to meeting the requirements of established standards and NIOSH certifications. For example, for Fluid Resistance, it states it meets ASTM F1862, which would have its own defined sample sizes for testing. The data provenance is not explicitly mentioned as a specific "country of origin" for testing, but given the applicant is a US LLC and the submission is to the FDA, it is likely that testing adhered to US regulations or internationally recognized standards. The study appears to be retrospective in the sense that it relies on existing standardized tests and certifications rather than a new prospective clinical trial.

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

This information is not provided in the document. The "ground truth" for the performance characteristics is established by the methods, parameters, and pass/fail criteria defined within the referenced standards (e.g., ASTM F1862, NIOSH TC 84A-4350, 16 CFR 1610). These standards are developed by expert committees, but the specific number and qualifications of individuals involved in the testing that led to these results are not detailed here.

4. Adjudication Method for the Test Set

This information is not applicable in the context of this submission. The "adjudication method" usually refers to how discrepancies are resolved when multiple human readers interpret data, often in medical imaging studies. Here, the performance is measured against objective technical standards which typically have clear pass/fail criteria, not subjective interpretations requiring adjudication.

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 document explicitly states: "No clinical data was required." The clearance is based on substantial equivalence to a predicate device, supported by technical performance testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is a physical N95 respirator, not an algorithm or AI system. The performance evaluated is that of the physical product itself.

7. The Type of Ground Truth Used

The ground truth used is primarily objective technical standards and certifications. These include:

• ASTM F1862 (for Fluid Resistance)
• NIOSH Certification Number (TC 84A-4350 for filtration efficiency and differential pressure)
• 16 CFR 1610 Standard for Flammability of Clothing Textiles
• Implied biological reactivity testing standards (for cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI or machine learning 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 training set for this device.

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The Prestige Ameritech N95 Respirator and Surgical Mask RP88020 is a single use non-sterile disposable device intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

The Prestige Ameritech N95 Particulate Filter Respirator & Surgical mask is manufactured using ultrasonic bonding, composed of four layers of materials pouched and pleated to form the Mask. The inner layer is composed of nonwoven, the two middle layers is meltblown polypropylene filter material and the outer layer is spunbond polypropylene. Masks are held in place on wearer with latex free elastic headband and contain a malleable aluminum nosepiece strip. All of the materials used in this device are typical materials commonly used in the construction of Respirator and Surgical Masks and are being used in current legally marketed devices.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

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 explicitly state the numerical sample size used for the test set for each performance metric. It consistently uses the phrase "Subject device samples," which indicates that a representative subset of the manufactured devices was tested for each criterion. The data provenance is not specified (e.g., country of origin). The studies appear to be prospective as they are tests performed on the manufactured device to demonstrate compliance.

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 to this type of device and study. The "ground truth" for the performance criteria of a respirator and surgical mask is established by widely accepted international and national standards (e.g., ASTM, NIOSH, ISO, CFR). The tests are objective measurements against these predefined standards, not subjective evaluations by experts to establish a "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are objective measurements against established standards, there is no need for an adjudication method involving experts. The results are quantitative and either meet the standard or they do not.

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 information is not applicable. The device is a physical medical product (respirator/surgical mask), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This information is not applicable. The device is a physical product and does not involve any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for each performance criterion is the established test methods and acceptance criteria set forth by recognized standards organizations. For example:

• Fluid Resistance: ASTM F1862
• Particulate Filtration Efficiency: ASTM F2299
• Bacterial Filtration Efficiency: ASTM F2101
• Differential Pressure: Mil M36954C
• Flammability: 16CFR 1610
• Biocompatibility: ISO-10993-10-2002
• Sodium Chloride Penetration, Inhalation Resistance, Exhalation Resistance: NIOSH standards

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical product, not an AI model that requires a training set. The manufacturing process is designed to consistently produce devices that meet the specifications.

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

This information is not applicable for the same reasons as point 8.

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The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask meets CDC Guidelines for TB Exposure Control within healthcare facilities. This device is also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

The Moldex-Metric type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.

The provided document is a 510(k) summary for the Moldex-Metric Model 1712 N95 Healthcare Particulate Respirator and Surgical Mask. It describes the device, its intended use, and performance tests conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Fluid Resistance: 32 samples were tested. Data provenance is not explicitly stated (e.g., country of origin), but the test was conducted in accordance with ASTM F 1862, a recognized international standard. The test appears to be prospective for the Model 1712.
• Flammability: 10 samples were tested. Data provenance is not explicitly stated, but the test was conducted in accordance with 16 CFR 1610. The test appears to be prospective for the Model 1712.
• Filter Efficiency: 20 samples were tested. Data provenance is not explicitly stated, but the test was conducted by NIOSH in accordance with 42 CFR Part 84, suggesting a U.S. regulatory context. The test appears to be prospective; the device was certified by NIOSH.
• Breathing Resistance (Inhalation and Exhalation): 3 samples were tested for each. Data provenance is not explicitly stated, but the test was conducted by NIOSH in accordance with 42 CFR Part 84, suggesting a U.S. regulatory context. The test appears to be prospective; the device was certified by NIOSH.
• Biocompatibility (Cytotoxicity, Sensitization, Primary Skin Irritation): The document states these tests were conducted on predicate devices made from the same material. The specific number of samples for these predicate device tests is not detailed in this summary.
• Bacterial Filtration Efficiency: The document states this test was conducted using the Modified Greene and Vesley Method. The specific sample size is not detailed for the Model 1712 directly, but it indicates "Greater than 99.9%" results derived from "Test results show a bacterial filtration efficiency greater than 99.9%." It also notes that this test was "conducted using the Modified Green and Vesley Method... for the predicate devices."

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

This document describes the performance testing of a physical device (respirator mask) against established technical standards and regulatory requirements. It does not involve human expert interpretation of medical images or data where "ground truth" is established by medical experts in the traditional sense (e.g., radiologists interpreting images). The "ground truth" here is objective measurement against specified physical and biological performance standards.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements and compliance with numerical or categorical standards (e.g., "32 of 32 pass," ">95% efficient," "Score of 0"). There is no subjective interpretation requiring an adjudication process for consensus among experts.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical product (respirator mask), not an AI algorithm for diagnostic interpretation that would involve human readers.

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

Yes, the device's performance was evaluated in a standalone manner against objective performance criteria. The tests (fluid resistance, flammability, filter efficiency, breathing resistance, biocompatibility, bacterial filtration efficiency) assess the physical and biological characteristics of the mask itself, without human-in-the-loop performance being a variable in these specific tests.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests described are:

• Objective physical and biological measurements: This includes quantified values (e.g., percentage efficiency, pressure measurements in mm H2O) and qualitative assessments (e.g., pass/fail for fluid resistance, flame spread classification, biocompatibility scores) against established industry and regulatory standards (ASTM, NIOSH, CFR, ISO).
• Predicate device performance data: For some tests (like biocompatibility and bacterial filtration efficiency), the ground truth for the new device's substantial equivalence is established by demonstrating that it performs similarly to or better than a legally marketed predicate device, which itself met regulatory ground truth requirements.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and the testing described does not involve machine learning or AI that would require a "training set" of data.

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

Not applicable, as no training set was used.

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The Safe Life B130 and B150 N95 Respirators and Surgical Masks are single-use disposable devices intended to protect healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. These respirators/surgical masks may be used during medical, surgical and dental procedures, and may also be used as isolation masks.

The Safe Life B130 and B150 N95 Respirators and Surgical Masks are single-use disposable devices.

This document is a 510(k) clearance letter from the FDA for a medical device: "Safe Life N95 Respirator and Surgical Mask, Models B130 and B150".

The provided text does not contain any information about acceptance criteria or the study that proves the device meets those criteria.

Instead, it's a regulatory letter confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses general controls, regulations, and reporting requirements, but not specific performance testing data.

Therefore, I cannot fulfill your request for the table of acceptance criteria, study details, sample sizes, ground truth information, or MRMC study results because this information is not present in the provided document.

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