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The Disposable Medical Face Masks are 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 the potential exposure to blood and body fluids. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.

Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (Spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (galvanized iron wire) to provide a firm fit over the nose.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the Disposable Medical Face Mask:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each performance test. It mentions for Fluid Resistance (ASTM F1862) that "32 out of 32 Pass at 120mmHg". This implies a sample size of 32 for that specific test. For other performance tests (BFE, Delta-P, PFE, Flammability) and biocompatibility tests, the sample sizes are not explicitly provided within this summary.

The data provenance is not specified (e.g., country of origin, retrospective/prospective). The submitting company is Suzhou Bolisi Medical Technology Co., Ltd in China, which suggests the testing was likely conducted in China or a contracted lab. It's safe to assume these are prospective tests performed specifically for this submission.

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

This information is not applicable to this type of device. The ground truth for performance standards of medical masks is established by standardized test methods (e.g., ASTM, EN, ISO) and the results are objectively measured by laboratories, not through expert consensus on cases.

For biocompatibility testing, the results are also determined by standardized laboratory assays, not by expert review of "cases."

4. Adjudication Method for the Test Set

This is not applicable as the tests performed are objective, quantitative measurements against predefined criteria, not subjective assessments requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices where human interpretation is involved. For a product like a disposable medical face mask, the assessment relies on objective performance testing and biocompatibility.

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

No, this is not applicable. This device is not an algorithm or AI system. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established performance standards and test methodologies for medical face masks and biocompatibility. Specifically:

• Performance Standards: ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610. These standards define the acceptable physical and filtration properties.
• Biocompatibility Standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization). These standards define the acceptable biological response to the device materials.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" for this type of medical device. The device's performance is not based on a machine learning model that needs training data.

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

This is not applicable for the same reason as above.

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