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The "MEDICAL FACE MASKS " is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided nonsterile.

The "MEDICAL FACE MASKS" is single use, white color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical face masks are manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene. The "MEDICAL FACE MASKS" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.

Here's a breakdown of the acceptance criteria and study information for the "MEDICAL FACE MASKS, Model Name: MY020003" based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Performance Tests: For BFE, PFE, Differential Pressure, and Synthetic Blood Penetration Resistance, the reported sample size is 32 samples (indicated by "32pass/32tested"). For Flammability, the number of specimens is not explicitly stated but implied to be sufficient for 16 CFR Part 1610 testing (which typically involves multiple specimens).
• Sample Size for Biocompatibility Tests: The documentation does not specify the exact number of L-929 cells for cytotoxicity, guinea pigs for skin sensitization, or New Zealand white Rabbits for skin irritation. It describes the test methods from the ISO standards, which define typical sample sizes.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. However, given that it is a 510(k) submission for a Chinese manufacturer (Huizhou Jie Bai Purification Co.,Ltd. in Huizhou, Guangdong, China), it can be inferred that the testing was likely conducted in China, often by contract research organizations (CROs) that adhere to international standards. These tests are part of a regulatory submission, so they are inherently prospective for the purpose of demonstrating device safety and effectiveness.

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

This section is not applicable to this type of device and study. The "Medical Face Masks" is a physical product, and its performance and biocompatibility are evaluated through standardized laboratory tests (e.g., ASTM, EN, ISO standards), not through expert consensus on diagnostic interpretations. The "ground truth" for these tests is the objective measurement of physical and biological properties against defined standards.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies) where an agreement between multiple readers is required to establish a ground truth when a definitive external standard (like pathology) is unavailable. For medical device performance testing, the results are objectively measured according to the specified test methods.

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 is not applicable. This submission details the performance and biocompatibility of a medical face mask, which is a physical barrier device. It does not involve any AI components, human readers, or diagnostic interpretation, therefore, an MRMC comparative effectiveness study is not relevant.

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

This is not applicable. As stated, the device is a medical face mask, not an algorithm or AI-powered system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance and biocompatibility of this device is established by objective measurements and observations against pre-defined scientific and regulatory standards. For example:

• Performance: Measured values (e.g., BFE %, PFE %, ΔP, blood penetration resistance) are compared directly to the numerical acceptance criteria specified in the ASTM and EN standards. Flammability is observed and categorized based on burn times.
• Biocompatibility: Cell viability, skin reactions (erythema, edema), and sensitization responses are observed and categorized according to the methodologies and criteria outlined in the ISO 10993 standards and then compared to the acceptance criteria to determine "non-cytotoxic," "non-sensitizing," and "non-irritating."

8. The Sample Size for the Training Set

This is not applicable. The device is not an AI algorithm or a trainable system. Therefore, there is no "training set."

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

This is not applicable because there is no training set.

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