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The surgical 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, provided non-sterile.
Level 2 Face Mask Models: FCY-L2-E, FCY-L2-T
Level 3 Face Mask Models: FCY-L3-E, FCY-L3-T

The Proposed device has one size 17.5 cm x 9.5 cm and two wear types of Ear Loops and Tie-On. They are available in blue and white colors and three barrier levels (Level 3) according to ASTM F2100:2019. The proposed Level 2 and Level 3 masks are the same product which can pass ASTM F2100-19 Level 2 & 3 at the same time; they are classified into level 3 just because of the marketing strategies. All the materials of proposed tie-on masks are included in ear loops masks. The outer layer, inner layer, middle melt-blown layer and PET coated iron wire nose clip of tie-on masks are exactly the same with ear-loop masks, the tie tapes of tie-on masks are same as the outer layer of white mask body but 3 layers folded and physically ultrasonic welding together. The proposed mask can form a physical barrier by being worn on the mouth and nose of medical staff to protect both the patient and healthcare personnel from the spread of microorganisms, blood and body fluids, and particulate materials. The proposed subject device, surgical face mask, operates by acting as a physical barrier. The barrier protects the medical staff, patient, and healthcare personnel from the spread of microorganisms, blood and body fluids, and particulate materials. The barrier goes over the mouth and nose of the user.

This document is a 510(k) Pre-Market Notification for a Surgical Face Mask. It details the performance criteria and the testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for surgical face masks are standardized by ASTM F2100-19. The table below outlines these criteria and the reported performance of the proposed device (K210225) for Level 2 and Level 3 masks. The predicate device (K160269) is also included for comparison.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many masks were tested for BFE, PFE). However, it indicates compliance with recognized standards. Typically, these standards (like ASTM F2100) specify minimum sample sizes for testing.

The data provenance is from non-clinical tests conducted to evaluate the device's performance against established standards. The country of origin of the data is not explicitly stated, but the submission is from Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd, which is located in China, suggesting the testing was likely conducted or commissioned in China. The data is retrospective in the sense that the tests were performed on finished devices to gather data for the pre-market submission.

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

This type of information is not applicable to this submission. The "ground truth" for evaluating surgical face masks in this context is based on objective, standardized test methods defined by recognized consensus standards (e.g., ASTM F2100), not on expert consensus or interpretation of images/data. The compliance with these standards is measured by laboratory testing.

4. Adjudication Method for the Test Set

This is not applicable to this type of device evaluation. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human interpretation (e.g., radiology reads) where there can be disagreement among experts. For performance testing of masks, the results are typically quantitative and objective, based on machine or laboratory measurements according to a defined protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. This document describes the performance of a physical medical device (surgical face mask), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable. As mentioned above, this is not an AI-powered device.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on objective measurements derived from standardized non-clinical test methods. These tests evaluate specific physical and performance characteristics of the mask materials and construction. Examples include:

• Synthetic Blood Penetration Test (ASTM F1862/F1862M-17) for fluid resistance.
• Particulate Penetration Test using Latex Spheres (ASTM F2299/F2299M-03(2017)) for particulate filtration efficiency.
• Bacterial Filtration Efficiency (BFE) Test (ASTM F2101-19) for bacterial filtration efficiency.
• Differential Pressure Test (EN 14683:2019+AC: 2019 Annex C) for breathability.
• Flammability Standard (16 CFR 1610) for fire resistance.
• Biological Evaluation Tests (ISO 10993-5 and ISO 10993-10) for biocompatibility (cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device and its evaluation. Training sets are relevant for machine learning or AI models, which are not involved here.

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

This is not applicable, as there is no training set.

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