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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. It 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(s), provided non sterile.

The medical surgical mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

The provided text describes the performance criteria and testing for a Medical Surgical Mask to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: For performance tests, the number of samples varied by test:
  • Bacterial filtration efficiency: 32 samples
  • Differential pressure: 32 samples
  • Sub-micron particulate filtration efficiency: 32 samples
  • Resistance to penetration by synthetic blood: 32 samples
  • Flame spread: 32 samples
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It only refers to "Non-Clinical Test Conclusion."

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

• Not Applicable: For this type of medical device (surgical mask), the "ground truth" is established through standardized laboratory testing against objective criteria, not through expert consensus or interpretation of medical images. The tests listed are objective physical and microbiological measurements.

4. Adjudication Method for the Test Set:

• Not Applicable: As the "ground truth" is established by standardized test methods with objective pass/fail criteria, an adjudication method in the sense of multiple expert reviews is not relevant. The results are based on the direct output of the specified ASTM and EN standards.

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 device is a physical surgical mask and does not involve AI or human "readers" interpreting data. Therefore, an MRMC study is not relevant.

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

• Not Applicable: This device is a physical surgical mask and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

• The ground truth for the performance criteria is based on standardized laboratory test methods (e.g., ASTM F2101-19, EN 14683:2019, ASTM F2299-03, ASTM F1862M-17, 16 CFR Part 1610, ISO 10993-1/5/10). These methods define objective parameters and thresholds for acceptable performance.

8. The Sample Size for the Training Set:

• Not Applicable: This device is a physical product, not an AI or machine learning model, so there is no "training set."

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

• Not Applicable: As there is no training set for a physical device, this question is not applicable.

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