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When properly worn, the Ear-Friendly Masks are intended to protect and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.

The Ear-Friendly Masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) Summary for the "Ear-Friendly Mask."

Device Description:
The Ear-Friendly Mask is a non-sterile, single-use, 3-layer, flat-pleated surgical face mask with ear loops and a nose piece. It is intended to protect both patients and healthcare workers from the transfer of microorganisms, body fluids, and particulate material.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Ear-Friendly Mask are based on the ASTM F2100 standard for the performance of materials used in surgical face masks, specifically for Level 3 performance. The table below outlines the acceptance criteria and the device's reported performance:

The document states, "All Result of testing met ASTM F2100 Level 3 acceptance Criteria."

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

The document does not explicitly state the specific sample sizes used for each of the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability, Biocompatibility).

Data Provenance: The studies were non-clinical (bench testing and biocompatibility), conducted by the manufacturer, RAY Co., Ltd., based in Anyang-si, Gyeonggi-do, Korea. The provenance is therefore prospective industrial testing aimed at regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable (N/A). This submission pertains to a physical medical device (surgical face mask) and its performance characteristics (filtration, fluid resistance, etc.), along with its biocompatibility. The "ground truth" for these tests is established through standardized laboratory methods (e.g., ASTM F tests, ISO 10993). There is no mention or requirement for human experts (e.g., radiologists) to establish ground truth as would be the case for an AI/CADe device interpreting medical images.

4. Adjudication Method for the Test Set

• Not applicable (N/A). As these are objective, standardized physical and chemical tests, there is no need for an adjudication method in the way one would adjudicate human expert interpretations in a clinical study. The tests yield quantitative results that are compared directly against the predefined numerical acceptance criteria.

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 (surgical face mask), not an AI-assisted diagnostic or imaging device. Therefore, studies involving human readers or their improvement with AI assistance are not relevant.

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

• Not applicable (N/A). This device is a physical medical product, not an algorithm or software device. The concept of "standalone performance" for an algorithm is not relevant here. The tests performed are purely bench and biocompatibility tests on the physical mask itself.

7. The Type of Ground Truth Used

The ground truth for this device's performance relies on objective, standardized laboratory test results as defined by:

• Consensus Standards: ASTM F2100 (for mask performance) and ISO 10993 (for biocompatibility).
• Specific Test Methods: ASTM F1862 (Fluid Resistance), ASTM F2299 (PFE), ASTM F2101 (BFE), MIL-M-36954C (Differential Pressure), 16 CFR part 1610 (Flammability), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization/Irritation).

The "ground truth" is whether the quantitative results obtained from these tests meet the specified numerical acceptance criteria for a Level 3 surgical mask.

8. The Sample Size for the Training Set

• Not applicable (N/A). This device is not an AI/ML product developed using training datasets. The 'training set' concept does not apply to the manufacturing and testing of a physical product like a surgical face mask.

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

• Not applicable (N/A). As there is no training set for an AI/ML model, there is no ground truth to be established for it. The product's compliance is demonstrated through a series of physical and chemical performance tests.

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