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Aearo Surgical N95 Respirators, N9504C, N9504CS and N9514 are intended for single 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. This includes use as a procedure mask. isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.

These masks are molded cup masks, with a center layer of polypropylene meltblown material sandwiched by inner and outer layers of nonwoven material. The mask has 2 elastic headbands. No fiberglass media is used in this product.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on Acceptance Criteria:

• The document sometimes states the acceptance criteria in the narrative and sometimes directly in the table. The table combines this information.
• For Fluid Resistance, the narrative states "29 of 32 show no fluid penetration," while the table states "32 of 32 pass." The reported performance of "32 of 32 pass" clearly meets both.
• The breathing resistance acceptance criteria are derived from NIOSH 42CFR Part 84, which specifies maximum allowed resistance for inhalation and exhalation. The provided data are for inhalation.

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

• Fluid Resistance: 32 masks
• Flammability Class: 10 samples
• Filter Efficiency: 20 samples
• Breathing Resistance: 3 samples for each model (N9514C, N9504C, N9504CS), totaling 9 samples.
• Bacterial Filtration Efficiency (BFE): "all samples tested" (specific number not given, but described using a biological aerosol of Staphylococcus aureus)
• Biocompatibility - Cytotoxicity: "None of the mask samples tested" (specific number not given)
• Biocompatibility - Primary Skin Irritation: 3 rabbits
• Biocompatibility - Delayed Hypersensitivity: Albino guinea pigs (specific number not given, but based on ISO 10993-10, 2002 requirements)

Data Provenance: The studies were conducted by various laboratories, including Nelson Laboratories and AppTec Laboratory Services. The location of these labs (e.g., country of origin) is not specified. The studies appear to be prospective tests performed specifically for this 510(k) submission, confirming the device's performance against established standards.

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

This section is not applicable to this type of device (N95 respirators) and testing. The "ground truth" for these performance characteristics (fluid resistance, flammability, filtration efficiency, biocompatibility) is established by adherence to standardized, objective test methods (e.g., ASTM, NIOSH, ISO) and laboratory measurements, not by expert consensus or interpretations of complex data like medical images. The expertise lies in conducting the tests according to the specified protocols and interpreting the objective results.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies where individual expert assessments need to be combined or resolved, such as in clinical image interpretation or diagnostic evaluations. The tests performed for this device are objective laboratory measurements with numerical or categorical outcomes (e.g., pass/fail, percentage, score of X).

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 section is not applicable. MRMC studies are used to evaluate the diagnostic performance of medical devices that involve human interpretation, often assisted by AI. This submission is for an N95 respirator, which is a physical barrier device, not a diagnostic tool requiring human interpretation or AI assistance.

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

This section is not applicable. "Standalone performance" refers to the performance of an AI algorithm without human involvement. As stated above, this device is not an AI algorithm or a diagnostic tool.

7. The Type of Ground Truth Used:

The ground truth for these tests is based on objective, standardized laboratory measurements and physical property assessments using internationally recognized standards (ASTM, NIOSH, ISO).

• Fluid Resistance: Direct measurement of liquid penetration.
• Flammability: Observation of flame spread under controlled conditions.
• Filter Efficiency: Measurement of particle penetration through the material.
• Breathing Resistance: Measurement of pressure drop across the respirator.
• Bacterial Filtration Efficiency: Measurement of bacterial penetration.
• Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization on rabbits/guinea pigs) biological responses as per ISO standards.

8. The Sample Size for the Training Set:

This section is not applicable. The N95 respirator is a manufactured physical product, not a learning algorithm. Therefore, there is no "training set" in the context of machine learning or AI.

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

This section is not applicable for the same reason as point 8.

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