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The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).

The ProGear® Surgical Mask with Oxafence® inactivates of the following test viruses after five minutes of contact with the treated surface of the face mask in laboratory (in vitro) tests under a lighting intensity of 500 ± 25 lux.

Influenza A/PR/8/34/H1N1 (TC adapted, ATCC VR-1469), 3-log or 99.9% inactivation Betacoronavirus 1 OC43 (ATCC VR-1558), 4-log or 99.99% inactivation Feline Calicivirus F-9 (ATCC VR- 782), 4-log or 99.99% inactivation

Antiviral efficacy on other viruses has not been evaluated. Correlations between in vitro testing results and any clinical event have not been evaluated.

The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).

This document is a letter from the FDA regarding the clearance of a surgical mask, not a study report for an AI/ML device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement in the context of an AI/ML device.

The provided text describes the "Indications for Use" for the ProGear® Surgical Mask with Oxafence®, Model AV82030, and lists the antiviral efficacy against specific viruses in laboratory (in vitro) tests. This information pertains to the performance of the physical device as a surgical mask, not a software or AI/ML product.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device from this document.

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The Surgical Earloop Face Mask with Bottom Gap Shield 7410E and Surgical Tie-On Face Mask with Bottom Gap Shield 7410T are single use disposable devices 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.

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{
  "1. A table of acceptance criteria and the reported device performance": {
    "Fluid Resistance": {
      "Acceptance Criteria (mmHg)": "120",
      "Reported Device Performance (mmHg)": "Pass at 120"
    },
    "Bacterial Filtration Efficiency (BFE)": {
      "Acceptance Criteria (%)": "≥98",
      "Reported Device Performance (%)": "≥98"
    },
    "Particulate Filtration Efficiency (PFE)": {
      "Acceptance Criteria (%)": "≥98",
      "Reported Device Performance (%)": "≥98"
    },
    "Breathability (Delta P)": {
      "Acceptance Criteria (mm H2O/cm²)": "

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The Prestige Ameritech Pediatric/Child Face Mask is intended to be worn by the patient/Child Facemask is a single use, disposable device, provided non-sterile. The Pediatric/Child Facemask is intended to be worn by the patient (ages 4-12) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions where transfer of microorganisms, body fluids, and particulates can occur.

The Prestige Ameritech Pediatric/Childs Face Mask is manufactured using ultrasonic bonding, composed of three layers of materials and pleated to form the mask. The inner layer is composed of nonwoven, the middle layer is meltblown polypropylene filter material, and the outer layer is cellulose. Decorative patterns are printed with colored inks. Masks are held in place on wearer with knitted polyester/spandex elastic earloop and contain a malleable aluminum nosepiece strip. The Pediatric/Child's Face Mask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/Child's Face Mask is a single use, disposable device, provided non-sterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices. This product is not made with natural rubber latex.

The provided text describes the acceptance criteria and performance of the Prestige Ameritech Pediatric/Child's Face Mask, comparing it 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 for each test performed on the Prestige Ameritech Pediatric/Child's Face Mask. It mentions that the anthropometric study sample for determining fit was "representative of the current US population in both gender and racial distribution," implying a prospective study, but exact numbers are not given. The origin of the data is not specified beyond being generated for a U.S. 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)

This document pertains to the performance testing of a physical medical device (a face mask) against established industry standards. There is no mention of "experts" in the context of establishing ground truth for a test set, as the evaluation relies on standardized laboratory testing methods rather than expert interpretation of data like in an AI/imaging study.

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

Not applicable. The evaluation is based on objective laboratory test results against predefined standards, not on human 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 a review of a physical medical device (face mask) and does not involve AI or human "readers."

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

Not applicable. This is a review of a physical medical device (face mask) and does not involve an algorithm.

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

The "ground truth" for the device's performance is based on the results of standardized laboratory tests conducted according to recognized national and international standards (e.g., ASTM F2101, Mil M36954C, ISO 10993, CPSC, EN 71-3). These standards define the methodology and expected outcomes for measuring properties like filtration efficiency, breathability, flammability, and biocompatibility. For anthropometry, it's based on measurements against a "representative" population sample.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical device evaluation, not an AI model.

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

Not applicable. There is no "training set" as this is a physical device evaluation, not an AI model.

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The Communicator Surgical Facemask with Clear Window, FM86000, is single use disposable 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.

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This document is a 510(k) premarket notification for a medical device: the "Communicator Surgical Facemask with Clear Window". It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is an FDA letter to the applicant, Prestige Ameritech, Ltd., stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as classification, general controls, and compliance with federal statutes.

Therefore, I cannot extract the requested information.

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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 following Prestige Ameritech Surgical Masks are single use disposable devices 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.

Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, Peach Prestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, Peach Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, Yellow Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, Peach Prestige Ameritech Tie on Surgical Mask with splash shield-Blue, Green, White, Peach

The Prestige Ameritech Surgical Mask device is composed of three layers of material flat folded and pleated to form the Mask. The inner layer is composed of cellulose or spunbonded polypropylene, the middle layer is a meltblown polypropylene filter material and the outer layer is a medical grade tissue or spunbonded polypropylene. Masks with splash shields have anti-fog plastic shields attached to masks. Masks are held in place on wearer with tie strips or latex free elastic loops and contain a malleable aluminum nosepiece strip. All of the materials used in this device are typical materials commonly used in the construction of Surgical Face Masks and are being used in current legally marketed devices.

The provided 510(k) summary describes the Prestige Ameritech Face Mask, a surgical face mask. The acceptance criteria and device performance are based on bench testing of physical properties rather than clinical studies with human participants. Therefore, several of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information) are not applicable or cannot be extracted from this document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the results of the predicate devices, as the Prestige Ameritech device aims to demonstrate substantial equivalence by performing similarly or better.

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

• Sample Size: Not specified in the document. These are bench tests, so sample sizes would refer to the number of mask samples tested for each characteristic.
• Data Provenance: The data is generated from laboratory bench testing (non-clinical tests) of the device and predicate devices. No information about the country of origin or whether it's retrospective or prospective is provided, but it's understood to be prospective testing for the submission.

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 characteristics is established through standardized laboratory test methods (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL M36954C, 16CFR 1610). Experts are involved in designing and executing these tests, but "ground truth" isn't established through expert consensus in the typical sense for medical imaging or diagnostic devices.

4. Adjudication method for the test set

Not applicable. This is not a study involving human interpretation or subjective assessments 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 a surgical mask, not an AI-powered diagnostic device, so MRMC studies and AI assistance are not relevant.

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

Not applicable. This is a surgical mask, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is objective measurement against established industry standards and test methodologies. For example:

• Fluid Resistance: Visual observation of penetration after exposure to synthetic blood.
• Particulate Filtration Efficiency: Quantitative measurement of particle removal at a specific micron size.
• Bacterial Filtration Efficiency: Quantitative measurement of bacterial removal.
• Differential Pressure: Measurement of airflow resistance.
• Flammability: Classification based on burn rate.

8. The sample size for the training set

Not applicable. This is a physical device, and the submission does not describe a training set in the context of machine learning or AI.

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

Not applicable. No training set is described.

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