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The WYZ Surgical Mask is 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 a single use, disposable device(s), provided non-sterile.

The proposed device (model: WYZ201) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed devices are manufactured with three layers, the inner and outer layers are made of Polypropylene (PP) spun-bond, and the middle layer is made of Polypropylene (PP) melt-blown. The WYZ201 model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Elastic film based on styrene block copolymer (SBC) with polyolefin (PO) outer layer. Hotmelt based on styrene-isoprene block copolymers (SIS) Nonwoven on both sides based on polypropylene (PP) spun-bond. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Galvanized iron wire with PP+PE coating. The proposed devices are sold non-sterile and are intended to be single use, disposable device.

Here's an analysis of the provided text regarding the WYZ Surgical Mask (K211576), focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are presented in the "Non-Clinical Test Conclusion" section (pages 6-7).

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

For the performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability), the sample size used was 32 units per lot for each of 3 non-consecutive lots. This means a total of 96 units were tested for each of these performance metrics.

The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) summary for a new device, the testing would generally be prospective, meaning it was conducted specifically for this submission. The applicant is WYZ Medical Supplies LLC, located in College Station, TX, U.S.A., but the submission correspondent is in Shanghai, China. The testing labs are not specified, so the data provenance regarding the country of origin of the data from the testing itself is not clear from this document.

For biocompatibility testing (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly stated as a number of units, but rather "Under the conditions of the study," which typically implies sufficient samples were used to meet the standard's requirements.

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

This document describes non-clinical testing of a surgical mask, not a diagnostic device involving human interpretation of images or patient data. Therefore, the concept of "experts used to establish ground truth" (e.g., radiologists) is not applicable here. The ground truth is established by the standardized test methods themselves (e.g., ASTM, EN, ISO standards), which define objective measurements and criteria.

4. Adjudication Method for the Test Set

Since this is non-clinical performance and biocompatibility testing against predefined standards, there is no adjudication method (like 2+1 or 3+1) involving human experts. The results are objective measurements against specified criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-powered diagnostic devices with human readers, which is not the case for a surgical mask.

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

Not Applicable. The device is a physical surgical mask, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply. The tests summarized are for the physical properties and biological safety of the mask itself.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on objective, quantifiable measurements derived from internationally recognized and FDA-referenced standards (e.g., ASTM F1862, ASTM F2101, EN 14683, ISO 10993). These standards define specific test methodologies and criteria for evaluating the performance and safety of surgical masks.

8. The Sample Size for the Training Set

Not Applicable. This document pertains to the evaluation of a physical medical device (surgical mask), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not Applicable. As there is no AI algorithm being trained, there is no training set and therefore no ground truth establishment for a training set.

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