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The High Fluid-Resistant Surgical and Procedure 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 potential exposure to blood and body fluids. The face mask is a single use, disposable device, provided non-sterile.

The High Fluid-Resistant Surgical and Procedure Mask is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose. This device is not made from natural rubber latex.

The provided document is a 510(k) premarket notification for a High Fluid-Resistant Surgical and Procedure Mask, which is a Class II medical device. The study described focuses on benchtop performance testing and biocompatibility testing rather than a clinical study involving human readers or AI. Therefore, most of the requested information regarding AI, human readers, and ground truth establishment in a clinical context is not applicable.

Here's the summary of the acceptance criteria and the study performance for the device itself, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Type 3 mask, as per ASTM F2100. The acceptance criteria and performance data are primarily drawn from Table 2 and Table 3.

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

• Sample Size for Benchtop Tests: For each of the benchtop performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability), three non-sequential lots were tested. Each lot consisted of 32 samples, resulting in a total of 96 samples (3 lots * 32 samples/lot) for each specific test.
• Sample Size for Biocompatibility Tests: The document states that Biocompatibility testing was performed, but does not explicitly provide the sample size for these specific tests (Cytotoxicity, Skin Sensitization, Skin Irritation). These are typically laboratory-based tests on material extracts.
• Data Provenance: The document does not specify the country of origin of the data for these tests. The tests are benchtop performance and biocompatibility studies, not clinical studies, so the "retrospective or prospective" designation as it typically applies to patient data is less relevant here. These are laboratory-executed tests.

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

This information is not applicable as the document describes the testing of a physical medical device (a surgical mask) through benchtop performance and biocompatibility tests, not the evaluation of an AI algorithm or a clinical study requiring human expert review for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are relevant to studies involving human interpretation or clinical data, not the physical testing of a mask.

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

This information is not applicable as the document concerns the premarket notification of a surgical mask, which is a passive device. It does not involve AI or human readers for diagnostic interpretation.

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

This information is not applicable as the device is a physical surgical mask, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective, standardized laboratory test methods (ASTM and ISO standards) for physical and biological properties. For example:

• Fluid Resistance: Measured resistance to synthetic blood penetration at a specific pressure.
• Filtration Efficiency: Measured percentage of particulates/bacteria filtered.
• Differential Pressure: Measured breathability.
• Flammability: Measured burn time.
• Biocompatibility: Measured cellular response (cytotoxicity), and skin reactions (sensitization, irritation) to material extracts.

8. The Sample Size for the Training Set

This information is not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. Device specifications and manufacturing processes are developed based on engineering principles and regulatory standards.

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

This information is not applicable for the reasons stated above. The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science, and the requirements outlined in relevant ASTM and ISO standards for surgical masks.

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