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The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask are composed of four-layers and are flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, green), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains tie strings or ear loops to secure the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask may also contain a face shield (FS) made from a polyethylene terephthalate film, which includes an antireflection strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face. The mask is a single use, disposable device, provided non-sterile.

This document is a 510(k) Summary for the 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask. It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a detailed "Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 3" table. This table serves as the primary source for acceptance criteria and the reported performance of the subject device.

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

The document provides the following sample sizes for the performance tests:

• PFE, Fluid Resistance, BFE, Differential Pressure: "32/32 Passed" indicates a sample size of 32 units tested for each of these criteria.
• Flammability: "5/5 Passed" indicates a sample size of 5 units tested.
• Biocompatibility: No specific sample size is mentioned in the table; however, the standards ISO10993-1, ISO10993-5, and ISO10993-10 are referenced, which would involve in vitro and potentially in vivo testing with relevant samples.

The document does not explicitly state the provenance of the data (e.g., country of origin) or whether the studies were retrospective or prospective. Given the context of a 510(k) submission, these would typically be internal testing results conducted by the manufacturer or a contracted lab to demonstrate compliance with recognized standards.

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

The concept of "ground truth" and "experts" is not applicable in this context. This document pertains to the evaluation of a medical device (surgical/procedure masks) based on
physical, chemical, and biological performance characteristics as defined by established industry standards (ASTM, MIL-M, CFR, ISO). The "ground truth" for these tests is the quantitative measurement of the device's properties against predefined thresholds in the standards, not expert subjective assessment.

4. Adjudication Method for the Test Set:

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or interpretations. These methods are not relevant for the type of objective physical and biological performance testing described for surgical masks. The results are quantitative and pass/fail based on the specific test methods and criteria.

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

No MRMC comparative effectiveness study was done. MRMC studies are relevant for evaluating the performance of diagnostic devices or AI algorithms where human readers interpret medical images or data. This document describes the testing of a passive barrier device (surgical masks), not a diagnostic or AI-driven device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No standalone (algorithm only) study was done. This concept is applicable to AI/ML software as a medical device (SaMD) where the algorithm performs a task independently. The device in question is a physical surgical mask and does not involve any algorithms or AI.

7. Type of Ground Truth Used:

As explained in point 3, the "ground truth" for this device's performance evaluation is based on established objective measurements against pre-defined thresholds specified in recognized international and national standards. These standards dictate the test methods and acceptance criteria for:

• Particulate Filtration Efficiency (ASTM F2299)
• Fluid Resistance (ASTM F1862)
• Bacterial Filtration Efficiency (ASTM F2101)
• Differential Pressure (MIL-M-36954C)
• Flammability (16 CFR Part 1610)
• Biocompatibility (ISO 10993 series)

The results indicate whether the device "Passed" or "Failed" these objective criteria in comparison to the predicate device.

8. Sample Size for the Training Set:

The concept of a "training set" is relevant for machine learning algorithms. This document describes the testing and comparison of a physical medical device (surgical mask). Therefore, there is no training set used in the context of this submission.

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

Since there is no training set for this type of device submission, this question is not applicable.

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