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The surgical 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided nonsterile.

The Surgical Face Masks (Ear loops and Tie-on) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.

The provided document describes the acceptance criteria and performance of Surgical Face Masks (Ear loops and Tie-on) as part of a 510(k) premarket notification. The study aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove device meets an absolute acceptance criteria.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" but rather "performance requirements" as outlined by recognized standards (ASTM F2100-11 for various levels) and then reports the device's performance against these requirements. It also compares the proposed device's performance to predicate devices.

Acceptance Criteria (Performance Requirements from ASTM F2100-11) and Reported Device Performance

Note: For ASTM F2299 and ASTM F2101, the document reports "Pass at" a certain percentage. The acceptance criteria for these would typically be a minimum percentage, which the reported values exceed.
Note: For Differential Pressure, the acceptance criteria are maximum values (e.g., <5.0 mmH2O/cm²), and the device's reported values fall within these limits.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for the individual performance tests (e.g., how many masks were tested for fluid resistance). The nature of these tests (e.g., ASTM F1862, F2299, F2101) typically involves standardized replicates as specified by the respective standards.

The data provenance is from non-clinical tests conducted on the proposed device. The country of origin of the data is not specified, but the applicant is from Japan (SAN-M PACKAGE CO., LTD.) and the US Correspondent is Globizz Corporation. The tests are "non-clinical tests" as opposed to human studies, so the retrospective or prospective nature in the clinical sense is not directly applicable. These are laboratory-based performance tests usually conducted in a controlled environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of device and study. The "ground truth" for these tests are the established performance requirements of the referenced ASTM and ISO standards, which are objective, quantifiable measurements (e.g., pass/fail for fluid penetration, percentage filtration, pressure drop). These are not subjective interpretations requiring expert consensus.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving subjective assessments by human readers/experts to resolve discrepancies. The performance tests for surgical masks are objective laboratory measurements against predefined 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

This is not applicable. The device is a surgical face mask, not an AI-powered diagnostic device. No MRMC study was conducted.

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

This is not applicable as the device is a physical product (surgical face mask), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for these tests are the established performance requirements defined by recognized international and national standards:

• ASTM F2100-11: Standard Specification for Performance of Materials Used in Medical Face Masks
• ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
• ASTM F2299: Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulate Matter Using a Latex Sphere Aerosol
• ASTM F2101: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
• MIL-M36945C: General Performance Requirements for Filtering Facepiece Respirators (likely referenced for differential pressure, though the specific ASTM equivalent is often used now)
• 16 CFR 1610: Standard for the Flammability of Clothing Textiles
• ISO 10993 (specifically ISO 10993-5 and ISO 10993-10): Biological evaluation of medical devices for cytotoxicity, irritation, and sensitization.

These standards provide objective, measurable criteria, not expert consensus or pathology on individual cases.

8. The sample size for the training set

This is not applicable. This is a physical product, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This is not applicable as there is no "training set."

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