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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, there-layer, flat-pleaded masks with nose piece and ear loops/ties, which are composed of outer layer, middle layer and inner layer. The outer layer and inner layer of the mask are made of polypropylene, the middle layer is made of melt-blown polypropylene. The ear loop/ties of the subject mask is held in place over the users' mouth and nose by two ear loops/ties welded to the face mask. The ear loop is made with polyester 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 high density polyethylene. 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 Standard Specification for Performance of Materials Used in Surgical Face Masks.

The provided document is a 510(k) summary for a Surgical Face Mask. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is categorized as a "Level 3 Barrier" surgical face mask.

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

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of masks tested for BFE, PFE, etc.). It only indicates "Passed" for the results.

The data provenance is from non-clinical tests performed on the "Surgical Face Mask" manufactured by Xiantao Sanda Industrial Co., Ltd. The tests were conducted according to FDA guidance and international standards (ASTM, EN, ISO). The country of origin of the data is implied to be where the manufacturer is located or where the testing was contracted, which is China (Xiantao, Hubei). These are laboratory tests, not human data, so "retrospective or prospective" does not directly apply in the same way it would for clinical studies.

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

This section is not applicable as the ground truth for device performance in this context is established by objective, standardized test methodologies and established acceptance criteria from recognized international standards (ASTM, EN, ISO) and FDA guidance documents. There are no human experts establishing ground truth for these physical and biological performance tests.

4. Adjudication Method for the Test Set

This section is not applicable. The "adjudication method" primarily refers to expert review processes for cases, which is relevant for clinical studies or image-based diagnostic AI. For non-clinical device performance tests like those described (e.g., filtration efficiency, breathability, flammability), the results are quantitative and objective, determined by the test procedures outlined in the standards.

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. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images or data, often in the context of AI assistance. This document describes a physical medical device (surgical face mask) with performance evaluated through non-clinical laboratory testing.

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

This section is not applicable. This document describes a physical surgical face mask, not an algorithm or AI-based device. The term "standalone performance" typically refers to the performance of an algorithm without human intervention, which does not apply here.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established scientific and engineering standards and their specified test methodologies. For example:

• Bacterial Filtration Efficiency (BFE): Measured according to ASTM F2101, using a biological aerosol of Staphylococcus Aureus. The "ground truth" is the empirically measured percentage of bacteria filtered.
• Differential Pressure: Measured according to EN 14683:2019 Annex C, the "ground truth" is the physical measurement of pressure drop across the mask.
• Sub-micron Particulate Filtration Efficiency (PFE): Measured according to ASTM F2299-17, using latex spheres. The "ground truth" is the empirically measured percentage of particles filtered.
• Resistance to Penetration by Synthetic Blood: Measured according to ASTM F1862-17. The "ground truth" is whether the synthetic blood penetrates the material at a specific pressure.
• Flammability: Assessed according to 16 CFR Part 1610-2008. The "ground truth" is the material's flammability classification.
• Biocompatibility: Evaluated according to ISO 10993 series (ISO 10993-5 for Cytotoxicity, ISO 10993-10 for Sensitization and Irritation). The "ground truth" is the biological response observed in standardized in vitro or in vivo tests.

These tests provide objective, measurable outcomes against predefined criteria.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The performance is assessed through direct physical and biological testing.

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

This section is not applicable for the same reason as point 8; there is no training set mentioned or implied for a physical medical device like a surgical face mask.

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The Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face 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, provided non-sterile.

The proposed device is a three-layers, flat-pleated mask. Its size is 17.5 cm x 9.5 cm, and it is available in two types, Ear-loop and Tie-On. Both the ear loop and tie-on masks are available in three barrier levels (Level 1, Level 3) based on ASTM F2100: 2019. The mask body is composed of three layers which is made of PP non-woven cloth. The difference between the three levels mask is the density of middle material. The ear loop or tie strings is used to secure the mask over the users' mouth and face. The nosepiece provides a firm fit over the nose. Ear loops are made of Nylon and spandex, and tie strings are made of PP non-woven cloth. The nose clip is made of Aluminum wire.

The provided text is a 510(k) summary for a Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask. It describes the device, its intended use, and comparative testing against a predicate device (K160269) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

Acceptance Criteria and Device Performance

The device acceptance criteria are based on established standards for medical face masks, primarily ASTM F2100:2019, as well as standards for flammability and biocompatibility (ISO 10993 series). The performance of the proposed device is compared against these criteria and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comprehensive table (Table 2: Summary of Non-clinical Testing) outlining the test methodology, purpose, acceptance criteria, and results for the proposed device, categorized by three levels of performance (Level 1, Level 2, Level 3).

Study Proving Device Meets Acceptance Criteria

The study performed is a series of non-clinical, laboratory-based physical and biological performance tests.

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

• Sample Size: "Nonclinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results from three nonconsecutive lots of 32 samples per lots (total of 96 samples) for each level claimed below demonstrated that the proposed device complies with the following standards."
  • This means for each of the three levels (Level 1, Level 2, Level 3) of masks, 96 samples were tested. Thus, a total of 96 * 3 = 288 samples were tested across all levels for the performance and biocompatibility tests.
• Data Provenance: The document does not explicitly state the country of origin where the tests themselves were conducted, but the sponsor and designated submission correspondent are based in China. The study is retrospective, as it involves testing completed products against established standards.

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

• Not Applicable. For medical face masks, ground truth is established through standardized laboratory testing protocols (e.g., ASTM, EN, ISO standards), rather than expert consensus on individual "cases" or interpretations. The results are quantitative measurements or pass/fail determinations based on predefined acceptance criteria.

4. Adjudication Method for the Test Set:

• None. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., radiologists reading images) where disagreement or subjective assessment might occur. In this context of laboratory performance testing, the results are objective measurements against set criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study is not relevant here as the device is a medical face mask, not an AI-powered diagnostic tool, and the evaluation is based on physical and biological performance, not human reader interpretation (with or without AI assistance).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, by definition, these are standalone tests. The tests performed (fluid resistance, particulate filtration, bacterial filtration, differential pressure, flammability, biocompatibility) are all laboratory tests assessing the intrinsic properties and performance of the mask materials and construction. There is no "human-in-the-loop" component in the testing methodology itself beyond conducting the standardized procedures.

7. The Type of Ground Truth Used:

• Standardized Laboratory Test Results and Regulatory Standards/Acceptance Criteria. The ground truth for this device is based on the quantitative and qualitative outcomes of the physical and biological tests as defined by recognized national and international standards (e.g., ASTM F2100 for medical face mask performance, ISO 10993 for biocompatibility, 16 CFR Part 1610 for flammability). The device "meets acceptance criteria" if its measured performance falls within the specified ranges or passes the qualitative thresholds set by these standards.

8. The Sample Size for the Training Set:

• Not Applicable. This device is a manufactured product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML development. The consistency and quality of the production are assured through manufacturing controls and testing samples from production lots.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described device. The "ground truth" for ensuring the quality of the manufactured product is adherence to the established material specifications, manufacturing processes, and final product testing against the performance standards, validated with samples from production lots.

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