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

The Surgical Face Masks are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of outer facing layer and inner facing layer. The colorant is blue polypropylene (PP) master batch.

The outer facing layer and inner facing layer of the mask are made of spun-bond polypropylene, the middle layer is made of melt blown polypropylene. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped aluminium.

The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Surgical Face Masks.

Please find below the acceptance criteria and study information based on the provided text.

Note: The provided document is a 510(k) Premarket Notification for a Surgical Face Mask. It details performance testing against established standards for physical properties and biocompatibility, not for a software-based AI/ML medical device. Therefore, many of the requested categories (e.g., sample size for test set with data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with humans, training set details) are not applicable to this type of device and the information is not present in the document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance

Biocompatibility Testing:

Study Details (Applicable sections based on a non-AI/ML medical device)

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

• Sample Size: The document provides acceptance criteria for tests like "29 out of 32 pass at 80 mmHg" for synthetic blood penetration, indicating a sample size of 32 for that specific test. For other tests (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Flammability, and Biocompatibility tests), the specific sample sizes used in testing are not explicitly stated within the public 510(k) summary, only the "Passed" result against the criteria.
• Data Provenance: Not specified, but generally, such testing is performed in laboratories according to the cited ASTM, EN, and ISO standards. The tests were performed as "Non-clinical Test Conclusion" and "Non-clinical Testing."
• Retrospective or Prospective: Not applicable as this refers to device performance testing against physical and chemical properties as per standards, not clinical data collection.

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

• Not Applicable. This is a physical device subject to standardized performance testing, not an AI/ML device requiring human expert ground truth for image interpretation or similar. The "truth" is established by the test methods and their defined pass/fail criteria.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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/ML medical device.

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

• Not Applicable. This is not an AI/ML medical device.

7. The type of ground truth used:

• For performance criteria (e.g., filtration efficiency, breathability, synthetic blood penetration, flammability), the "ground truth" is established by the specified international and national standards (ASTM, EN, CFR) and their associated validated test methodologies.
• For biocompatibility, the "ground truth" for safety is established by the ISO 10993 series of standards (ISO 10993-5 for Cytotoxicity, ISO 10993-10 for Sensitization and Irritation), specifically evaluating the biological response of the materials.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML medical device that uses a "training set."

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

• Not Applicable. See point 8.

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

The Surgical Face Masks are blue color, four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of outer facing layer, second facing layer and inner facing layer. The colorant is blue polypropylene (PP) master batch.

The outer facing layer and inner facing layer of the mask are made of spun-bond polypropylene, the second facing layer is made of nylon single way filting net, the middle layer is made of melt blown polypropylene. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped aluminium.

The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Surgical Face Masks.

The document describes the acceptance criteria and the results of non-clinical tests for a Surgical Face Mask (HNFM0304) to demonstrate its substantial equivalence to a predicate device (K212097).

Here's the breakdown of the requested information:

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 individual mechanical and filtration tests (e.g., number of masks tested for BFE). However, for Resistance to Penetration by Synthetic Blood, the result explicitly states "32 out of 32 pass at 160 mmHg," indicating a sample size of 32 masks for this specific test.

For Biocompatibility Testing, the document mentions a "biocompatibility evaluation for the Surgical Face Mask was conducted," implying that the testing was performed on the device materials. The specific number of samples (e.g., cell cultures, animal subjects) for cytotoxicity, sensitization, and irritation tests is not provided in this summary.

The data provenance is from non-clinical tests conducted in line with international standards (ASTM, EN, ISO) and FDA guidance for surgical masks. The country of origin of the data is not explicitly mentioned but is presumably related to the manufacturer (Shanghai Hua En Industrial Co Ltd, China) or contracted testing laboratories. The document describes these as non-clinical tests, not retrospective or prospective human studies.

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

This information is not applicable as the document describes non-clinical performance and biocompatibility testing, not clinical studies involving expert interpretation or "ground truth" establishment in the context of medical image analysis or diagnostic performance. The ground truth for these tests is defined by the objective measurement criteria of the respective standards (e.g., percentage filtration, pressure drop, cell viability).

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. The tests are objective measurements against predefined criteria, not subjective interpretations 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. The document explicitly states: "No clinical study is included in this submission."

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

This information is not applicable as the device is a physical surgical face mask, not an AI algorithm or a software device.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established by objective measurement against predefined criteria specified in recognized international standards (e.g., ASTM F2100, EN 14683, ISO 10993). For example:

• Filtration Efficiency: Measured percentage of particles/bacteria blocked.
• Differential Pressure: Measured pressure drop across the material.
• Synthetic Blood Resistance: Observation of penetration at a specific pressure.
• Biocompatibility: In vitro (cytotoxicity) and in vivo (sensitization, irritation) laboratory test results against established biological response criteria.

8. The Sample Size for the Training Set

This information is not applicable. The document describes testing of a physical medical device (surgical face mask), not a machine learning model, so there is no training set in the context of AI/ML.

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

This information is not applicable for the same reason as point 8.

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