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Allmed Surgical Face Masks(Ear Loops) are intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The surgical face mask is a single use, disposable device provided non-sterile.

Allmed surgical face masks (ear loops) are composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene meltblown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical face mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.

The document describes the acceptance criteria and performance of the Allmed Surgical Face Masks (Ear Loops) as per their 510(k) summary. This is not a study of an AI-powered device, but rather a regulatory submission for a medical device (surgical face mask). Therefore, information related to AI-specific studies, such as multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth, or training set details, is not applicable or present in this document.

Here's the information available:

1. Table of acceptance criteria and the reported device performance:

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

The document does not specify the exact sample sizes used for each performance test (e.g., number of masks tested for BFE, PFE, etc.). It mentions AQL (Acceptable Quality Level) values for some tests, which implies a sampling plan was used, but the specific sample size "n" is not provided. The data provenance is presumed to be from testing conducted by or for Allmed Medical Products Co., LTD, based in China (No.180, GongYuan Road, Majiadian Town, Zhijiang City, Hubei Province), as they are the submitter of the 510(k). The tests appear to be a prospective evaluation of the manufactured device.

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

Not applicable. This is a medical device (surgical face mask) performance evaluation against established ISO/ASTM standards, not an AI or diagnostic imaging device requiring expert ground truth for interpretation.

4. Adjudication method for the test set:

Not applicable. Device performance is determined by passing predefined thresholds in standardized laboratory tests, not by expert 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 not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

The "ground truth" for the performance criteria is based on established international standards (ASTM, EN, ISO, CFR) for surgical face masks. These standards define the acceptable physical and biological properties for the device to perform its intended function.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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