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The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 2 and Level 3 based on ASTM F2100-19. The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask. This is a single use, disposable device(s), provided non-sterile.

The provided FDA 510(k) summary for the Azur Medical Company Inc. Medical Surgical Mask (K231719) details the acceptance criteria and study results for the device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Medical Surgical Mask with two types: Level 2 and Level 3, based on ASTM F2100-19.
The table below combines information from the "VII Comparison of technological characteristics with the predicate device" and "VIII Summary of Non-Clinical Tests" sections. Note that for some performance characteristics, the specific numerical results are given in comparison to the predicate, while for others, only "Pass" is stated against the acceptance criteria.

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

The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., how many masks were tested for PFE, BFE, etc.). It only reports the overall "Test results" as "Pass" or an average value for the proposed device.

The data provenance is not specified in terms of country of origin, but the testing would typically be performed by accredited labs. The studies described are non-clinical (laboratory-based performance testing and biocompatibility testing), not clinical trials, so the terms "retrospective" or "prospective" do not apply in the same way they would for patient data.

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

This information is not applicable to this document. The "ground truth" for non-clinical testing of a surgical mask is established by validated standardized test methods (e.g., ASTM, ISO standards) and their defined acceptance criteria. It does not involve expert consensus in the way clinical diagnostic studies might.

4. Adjudication Method for the Test Set

This is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers independently review cases and then resolve discrepancies. Non-clinical performance tests follow predefined protocols and acceptance criteria.

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 is not applicable to this document. This submission is for a physical medical device (surgical masks), not an AI/software as a medical device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or would be relevant.

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

This is not applicable to this document. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth for this device's evaluation is based on standardized test methods and their defined performance criteria, primarily from ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). For example:

• Particulate Filtration Efficiency: ASTM F2299/F2299M-03
• Differential Pressure: ASTM F2100: 2019
• Bacterial Filtration Efficiency: ASTM F2101: 2019
• Flammability: 16 CFR Part 1610
• Synthetic Blood Penetration Resistance: ASTM F1862/F1862M-17
• Biocompatibility: ISO 10993 series (ISO10993-5, ISO10993-23, ISO10993-10)

These standards define the methodology and the quantitative or qualitative criteria for "passing" the test, which serves as the ground truth.

8. The Sample Size for the Training Set

This is not applicable to this document. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device, not an AI/ML device, so there is no training set in this context.

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

This is not applicable to this document, as there is no training set for an AI/ML model for this device.

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