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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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The Medical Face 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. This is a single use, disposable device(s), provided non-sterile.

The Medical Face Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric. The Medical Face Masks are single use, disposable device, provided non-sterile.

The provided text describes the acceptance criteria and the study conducted for "Medical Face Masks" (K202627).

Here's the extracted information:

1. Table of Acceptance Criteria and Reported Device Performance:

   Methodology/Standard	Purpose	Acceptance Criteria	Reported Device Performance
   ASTM F1862M-17	Fluid Resistance Performance	29 out of 32 pass at 120mmHg	29 out of 32 pass at 120mmHg
   ASTM F2299	Particulate Filtration Efficiency	≥98%	Average 99.82% at 0.1μm
   ASTM F2101-19	Bacterial Filtration Efficiency	≥98%	Average 99.78%
   EN 14683:2019 Annex C	Differential Pressure	<6mmH2O/cm²	Average 3.3 mmH2O/cm²
   16 CFR 1610	Flammability	Class I Non Flammable	Meet Class I
   ISO 10993-5	In Vitro Cytotoxicity	Device is non-cytotoxic	Device is non-cytotoxic
   ISO 10993-10	Skin Irritation	Device is non-irritating	Device is non-irritating
   ISO 10993-10	Skin Sensitization	Device is non-sensitizing	Device is non-sensitizing

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

   • Fluid Resistance Performance (ASTM F1862M-17): The test involved 32 samples (29 out of 32 passed).
   • For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not explicitly stated in the provided text.
   • Data Provenance: Not specified, but the device manufacturer is based in China (Guilin HBM Sanitary Protections, Inc). The testing appears to be non-clinical laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. These are non-clinical performance and material characterization tests, not reliant on expert clinical interpretation or ground truth establishment in the traditional sense of medical image analysis or diagnostic studies.

4. Adjudication method for the test set:

   • Not applicable. The tests are standardized laboratory procedures with objective measurements.

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 for a Medical Face Mask, not an AI diagnostic device. No MRMC study was conducted.

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

   • Not applicable. This is for a Medical Face Mask. The tests performed are standalone performance tests for the physical product.

7. The type of ground truth used:

   • The "ground truth" for these tests refers to established scientific and regulatory standards (e.g., ASTM, EN, 16 CFR, ISO standards) against which the device's physical properties and performance characteristics are measured. For example, for "Bacterial Filtration Efficiency," the ground truth is the specified bacterial filtration efficiency percentage (≥98%).

8. The sample size for the training set:

   • Not applicable. This is a medical device (face mask) and not an AI/ML algorithm that requires a training set.

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

   • Not applicable, as there is no training set for this device.

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