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The Procedure Masks 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 to blood and body fluids. All models are single use, disposable devices, provided non-sterile.

Model GFM31A Procedure Mask will be provided with a nose wire for general medical use, and without a nose wire for use in an MRI environment. This model of Procedure Mask is manufactured with three layers. The user facing layer is made of white polypropylene spunbond; the filtration/middle layer is made of white polypropylene meltblown; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire, when present, is used to fit the facemask around the user's nose. The product intended to be used in an MRI environment is constructed with the same materials except for the nose wire. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.

Model GFM42A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.

Model GFM43A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.

The provided document contains information on the acceptance criteria and performance testing for a medical device (Procedure Mask). However, it does not include information typically associated with studies proving device performance against acceptance criteria in the context of AI/ML or diagnostic devices, such as:

• Sample size for a test set (it mentions testing on "three non-consecutive production lots" for the ASTM performance tests, which refers to the mask itself, not a dataset for an AI model).
• Data provenance for the test set.
• Number of experts or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of human readers improving with AI assistance.
• Standalone performance (for an AI algorithm).
• Type of ground truth (beyond the mask's physical performance).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a Procedure Mask, a physical medical device, not an AI/ML-driven diagnostic or image analysis device. Therefore, the questions related to AI/ML study design are not applicable to the information contained in this document.

The acceptance criteria here pertain to the physical and functional performance of the mask as per relevant ASTM and ISO standards for medical face mask materials and biocompatibility.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ASTM F2100 levels (Level 1, Level 2, Level 3) which define performance requirements for medical face masks. The tables within the document compare the proposed device's performance to the predicate device's performance against these standards.

Model GFM31A (ASTM Level 1)

*GFM31A uses the same materials as GFM43A, and GFM43A (a Level 3 mask) was subjected to all biocompatibility tests as the "worst case" model. GFM31A was specifically tested for cytotoxicity only.

Model GFM42A (ASTM Level 2)

*GFM42A uses identical materials to GFM43A, which was used for irritation and sensitization testing as a "worst case" model due to an additional layer of material.

Model GFM43A (ASTM Level 3)

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

• Test Set Sample Size: For the ASTM performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure), the tests were conducted "in triplicate on samples obtained from three non-consecutive production lots." For Fluid Resistance (ASTM F1862), it states "32 out of 32 passed at X mmHg, 3 lots," implying a sample size of 32 per lot for that specific test.
• Data Provenance: Not specified, but generally, such tests are conducted by certified laboratories as per industry standards. No information regarding country of origin or retrospective/prospective nature is given, as it's not relevant for a physical product's performance testing in this context.

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 a physical product's performance testing based on established standards (ASTM, EN, ISO). Ground truth is the defined standard performance, not expert opinion.

4. Adjudication method for the test set:

• Not applicable. Performance is measured directly against predefined quantitative 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 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 device.

7. The type of ground truth used:

• The ground truth is based on established industry standards and physical measurements. For example, for fluid resistance, the standard specifies a certain pressure; for filtration efficiency, it specifies a minimum percentage. For biocompatibility, it's defined by the absence of cytotoxicity, irritation, and sensitization as per ISO 10993.

8. The sample size for the training set:

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

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

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

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