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Single-use medical face mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.

The proposed device is single-use medical face mask. It is non-sterile and for single use. The single-use medical face mask is manufactured with three-layers, the inner and outer layers are made of spun-bond polyethylene, and the middle layer is made of melt blown Polyethylene. The elastic ear loop of proposed device is made of spandex and polyester, not natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from zinc strip. It is a self-inhalation filter mask, which works by filtering the air through the filter material of the mask before being inhaled or exhaled.

This document is a 510(k) summary for a Single-use medical face mask. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each performance test. It only mentions that "Performance testing was conducted on the single-use medical face mask." The data provenance is North America (as per ASTM standards), but the manufacturing country is China. The study is a non-clinical, retrospective study based on laboratory testing of the device.

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

Not applicable. The ground truth for this device's performance is established through standardized laboratory testing (e.g., ASTM standards) rather than expert consensus on images or clinical cases. The "experts" would be the certified laboratories performing these specific biomechanical/material tests, adhering to the outlined standards. Their qualifications are inherent in their accreditation to perform such tests.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.

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 a medical face mask, not an AI-powered diagnostic device. No human reader or AI comparative effectiveness study was performed or is relevant.

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

Not applicable. This is a physical medical device (face mask), not an algorithm.

7. The type of ground truth used

The ground truth used is based on standardized test methods and predefined quantitative acceptance criteria from regulatory and industry standards such as ASTM F2100-19, ASTM F1862, ASTM F2299, ASTM F2101-19, 16 CFR Part 1610, EN 14683:2019+AC:2019(E) Annex C, and ISO 10993 for biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for a physical medical device.

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