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The Surgical Face Mask is intended for single use by operation room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

The proposed device, Surgical Face Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m² PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of 25g/m² PP non-woven cloth. The nose clip which is made of high-density polyethylene and Galvanized wire. The device is provided in sterile.

This document is a 510(k) Premarket Notification for a Surgical Face Mask. The request asks for details about acceptance criteria and a study proving the device meets those criteria, typically found in AI/ML medical device submissions. However, this document is for a physical medical device (a surgical face mask), not an AI/ML device. Therefore, many of the requested categories (like number of experts for ground truth, MRMC studies, training set details, etc.) are not applicable and are not present in the provided text.

This document focuses on the performance of the surgical face mask based on established ASTM and ISO standards for biocompatibility and barrier protection.

Here's a breakdown of the available information based on your request, with a clear indication of what is not applicable for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides two tables: "Table 1 Summary of Biocompatibility Test Results" and "Table 2 Summary of Performance Testing".

Table 1: Summary of Biocompatibility Test Results

Table 2: Summary of Performance Testing (for Level 2 Mask - as per ASTM F2100-19)

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

• Sample Size: The document refers to testing "Lot #1, Lot #2, Lot #3" for performance tests. The specific number of masks/samples within each lot that were tested for each criterion is not stated in the provided text. This information would typically be found in the full test reports, which are summarized here.
• Data Provenance: The device manufacturer is "Shandong Haidike Medical Products Co., Ltd." located in Heze City, Shandong Province, China. The testing was performed according to international standards (ASTM, ISO, EN) and US regulations (CFR). This implies an origin from China, and the data is prospective as it's generated from physical testing of the manufactured product lots for the purpose of this submission.

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

Not Applicable. This is a physical device. "Ground truth" in this context refers to the measured performance against established physical standards rather than expert interpretation of medical images or data. The "ground truth" is defined by the test methods and the acceptance criteria established by the various ASTM, ISO, and EN standards.

4. Adjudication Method for the Test Set

Not Applicable. As this is a physical device, there's no "adjudication" in the sense of reconciling human expert opinions on a test set. Objective physical measurements are taken.

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 physical medical device (surgical mask), not an AI/ML device. There are no "human readers" or AI assistance involved in its function or evaluation.

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

Not Applicable. This is for a physical medical device. There is no algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is based on:

• Standardized Test Methods and Acceptance Criteria: As defined by the listed ASTM, ISO, and EN standards (e.g., ISO 10993 for biocompatibility, ASTM F2101 for bacterial filtration, EN 14683 for differential pressure).
• Objective Physical Measurements: The device's performance is measured against these established quantitative and qualitative criteria.

8. The Sample Size for the Training Set

Not Applicable. This is a physical product, not an AI/ML model that requires a "training set." The masks are manufactured and then tested to meet standards.

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

Not Applicable. See point 8.

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