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The surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials. This face mask is 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 as sterile.

The surgical face mask is provided as sterile, single use, 3 lavers, flat-pleated style with ear loops and nose-piece. The outer layer and inner layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt-blown fabric (polypropylene). Each mask contains ear loops to secure the mask over the user's face and mouth with nose-piece to firmly fit over the nose. This device is not made from any natural rubber latex.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for a Surgical Face Mask. It is important to note that this is a medical device, not an AI/Software as a Medical Device (SaMD), so the questions related to AI performance, such as MRMC studies, training sets, and expert adjudication, are not applicable in this context. The document focuses on physical, biological, and sterilization performance of the mask.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data are primarily found in section 7.2 Physical performance testing and the Biocompatibility section within the comparison table.

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

• Sample Size for Fluid Resistance Test: 32 samples (indicated by "32 out of 32 pass"). For other physical performance tests, the results are noted as "Statistics of three lots," but specific sample sizes are not explicitly stated for each test (e.g., how many masks constitute a "lot" for testing).
• Data Provenance: The tests were performed on the "proposed device" by the manufacturer, RFX+CARE Manufacturing Co., Ltd., which is based in Shaoxing, Zhejiang, People's Republic of China. The testing appears to be prospective as it was conducted specifically to support this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This submission is for a physical medical device (surgical face mask), not an AI/software device that requires expert adjudication for ground truth. The ground truth for performance is established through standardized laboratory testing (e.g., ASTM, EN standards).

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Testing is conducted according to established methodologies in laboratory settings, not through human adjudication of data.

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

• No. This is not an AI-assisted device. The comparison is made against a legally marketed predicate device (K182515) based on technical characteristics and performance standards. Human clinical studies are explicitly stated as not included in this submission (Section 7.4).

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

• Not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• The ground truth is established by validated laboratory test methods and established international and national standards (e.g., ASTM F2100-19, ASTM F1862-17, ASTM F2101-19, ASTM F2299-2007, EN 14683: 2019, 16 CFR Part 1610, ISO 10993-1, ISO 11135:2014, ISO 11737-1:2018, ISO 10993-7:2008). These standards define the acceptable performance parameters for surgical face masks and biocompatibility.

8. The Sample Size for the Training Set

• Not applicable. This refers to machine learning models, which are not relevant to this device.

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

• Not applicable. See point 8.

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