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MAF Guard is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid 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 single use, disposable device, provided non-sterile.

The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops or tie-on strings and a nose piece. The mask is 175 ± 5 mm by 95 ± 3 mm. The outer, blue layer and the inner, white layer are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. One model of the mask is secured to the face with two ear loops made of polyester Spandex that are 150 ± 10 mm long. The other model is secured with four spin bond polypropylene tie-on strings that are 450 ± 10 mm long. A nosepiece of steel core wire coated with polyethylene resin that is 110 ± 5 mm long conforms the mask to the shape of the nose.

The provided document is a 510(k) Summary for a surgical face mask (MAF Guard). It describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria for an AI/algorithm-based medical device.

Therefore, most of the requested information regarding AI/algorithm performance, such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance, is not applicable to this document.

However, I can extract the acceptance criteria and performance data for the physical characteristics and filtration efficacy of the surgical mask based on the provided tables.

Here's the information that can be extracted from the document, focusing on the appropriate acceptance criteria and "study" (non-clinical testing) for a surgical mask:

Device: MAF Guard Surgical Face Mask (Ear Loop model SM3P-MB25-2511; Tie-on model SM3P-MB25-2521)
Device Type: Surgical Face Mask
Regulatory Class: Class II
Product Code: FXX
Predicate Device: Non Woven Face Mask (K173062)

The study described is non-clinical performance testing to demonstrate that the MAF Guard surgical face mask meets established consensus standards for surgical masks, aligning with the "Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004."

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size for performance tests: The performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, and Flammability) were conducted on three non-consecutive lots of the device. For Fluid Resistance, 32 samples were tested per lot. The specific number of samples for other tests (e.g., for efficiency percentages or differential pressure) within each lot is not explicitly stated beyond "mean for three non-consecutive lots."
• Data Provenance: The document does not specify the country of origin where the testing was performed. It is implicitly retrospective as it's a 510(k) submission summarizing completed testing.

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

• Not applicable. This submission pertains to physical and performance specifications of a medical device (surgical face mask), not an AI/algorithm-based device requiring expert clinical ground truth evaluation. The ground truth is established by laboratory test methods and international/national standards (e.g., ASTM, EN, ISO).

4. Adjudication Method for the Test Set:

• Not applicable. This is not a clinical study involving human readers or subjective interpretations that would require an adjudication method. The testing relies on objective measurement and adherence to defined technical 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 is not an AI/algorithm-based device, and no MRMC study was performed. The device is a physical surgical face mask.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an AI/algorithm-based device. "Standalone performance" in this context refers to the intrinsic performance of the physical mask itself as measured by the specified tests.

7. The Type of Ground Truth Used:

• The ground truth is established by objective laboratory testing methods defined by recognized consensus standards (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration, ASTM F2101 for bacterial filtration, EN 14683 for differential pressure, 16 CFR 1610 for flammability, and ISO 10993 for biocompatibility). The acceptance criteria are derived from these standards, specifically aiming for Level 3 performance for surgical masks.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/algorithm-based device that requires a training set.

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

• Not applicable. This is not an AI/algorithm-based device.

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