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The Kangbeier Child Surgical Mask is intended to be worn by the patient (ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The Kangbeier Child Surgical Mask is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.

The Kangbeier Child Surgical Mask is composed of three layers of materials and pleated to form the mask. The inner layer is composed of spun-bond nonwoven polypropylene, the middle layer is meltblown polypropylene filter material, and the outer layer is spunbond nonwoven polypropylenen. The color on the outer layer is consists of Phthalocyanine Blue and PE wax and PP. Masks are held in place on wearer with elastic spun-bond polypropylene earloop and contain a malleable aluminum nosepiece strip.

The Kangbeier Child Surgical Mask is appropriately sized to the smaller faces of children across a diverse population.

The Kangbeier Child Surgical Mask is a single use, disposable device, provided nonsterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices.

The provided text is a 510(k) Summary for the Kangbeier Child Surgical Mask. It demonstrates the device's substantial equivalence to a predicate device, K160100, "Prestige Ameritech Pediatric/Child's Face Mask."

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 sizes used for each performance test. It only mentions that the device "has been tested under the following standards." The provenance of the data (country of origin, retrospective or prospective) is also not specified.

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

This information is not provided in the document. The tests performed are primarily laboratory-based physical and biological performance tests, not human-reader-based assessments requiring expert ground truth establishment in the traditional sense.

4. Adjudication Method for the Test Set:

Not applicable. The tests are scientific measurements against established standards, not judgmental interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is a physical surgical mask, not an AI-based diagnostic or assistive technology.

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.

7. The Type of Ground Truth Used:

For the performance metrics, the "ground truth" is defined by the objective measurement criteria within the listed ASTM, EN, and CFR standards. For example:

• Particulate Filtration Efficiency: Measured electronically against documented particulate sizes.
• Bacterial Filtration Efficiency: Measured using a biological aerosol of Staphylococcus aureus.
• Differential Pressure: Measured as resistance to airflow.
• Flammability: Measured according to defined burn rate criteria.
• Resistance to Penetration by Synthetic Blood: Measured by resistance to a fluid challenge at specified pressure.
• Biocompatibility: In vitro cytotoxicity and irritation/sensitization tests as per ISO 10993 standards.

These are all objective, laboratory-derived measurements rather than expert consensus, pathology, or outcomes data in a clinical context.

8. The Sample Size for the Training Set:

Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

Not applicable.

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The disposable surgical face masks are intended to be worn to protect 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 Kangbeier Surgical Mask (Model: KBR-1001) is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.

The document describes the non-clinical testing performed on the Kangbeier Surgical Mask (Model: KBR-1001) to support its 510(k) submission and demonstrate substantial equivalence to a predicate device. This device is a surgical mask, not an AI-based or image analysis device, therefore, many of the requested items related to AI/MRMC studies, ground truth establishment, and data provenance are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a clear table (Table 2) outlining the acceptance criteria and the results for several non-clinical performance tests.

Additionally, Biocompatibility testing was performed (Table 3):

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

• Sample Size for Test Set: For performance testing (Table 2), the sample sizes are indicated for each test:
  • Fluid Resistance: 3 lots tested, with 32 samples per lot (total 96 samples).
  • Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability: The document indicates results for 3 lots for each, but does not explicitly state the number of samples per lot for these tests. However, standard ASTM methods like F2101 and F2299 specify minimum sample sizes for reliable results. For flammability, it states "Did Not Ignite" for each lot.
• Biocompatibility Testing (Table 3): Standard biological tests (Cytotoxicity, Sensitization, Irritation) were performed according to ISO 10993. The specific sample sizes (e.g., number of cells, guinea pigs) are not detailed within this summary, but these are standardized animal/in-vitro models.
• Data Provenance: The tests are non-clinical (benchtop and biocompatibility) performed on the manufactured device. There is no mention of country of origin of the testing data itself, but the manufacturer is Xinxiang Kangbeier Medical Technology Co., Ltd. from China. These are laboratory tests, not retrospective or prospective patient data studies.

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

N/A. This is a physical device being tested against recognized performance standards (ASTM, ISO, CFR). "Ground truth" in the context of expert consensus (e.g., for image analysis) is not applicable here. The performance criteria are defined by the standards themselves, and the results are quantitatively measured by testing laboratories.

4. Adjudication Method for the Test Set

N/A. As this is a physical device undergoing standardized benchtop and biocompatibility testing, there is no human adjudication process involved in interpreting results in the way there would be for an AI algorithm's output. The criteria are objective measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. This document does not pertain to an AI algorithm or an imaging device, thus, an MRMC study is not relevant or performed.

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

N/A. No algorithm is involved. This is a medical device (surgical mask) that is physically tested.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by international and national standards (ASTM F1862, ASTM F2299, ASTM F2101, ASTM F2100, 16 CFR 1610 for performance, and ISO 10993 for biocompatibility) and regulatory guidance from the FDA. These standards define the acceptable range or threshold for specific physical and biological properties. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in the way it's understood for diagnostic AI/imaging devices.

8. The Sample Size for the Training Set

N/A. This is a medical device, not an AI model, so there is no "training set."

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

N/A. No training set is applicable for this type of device submission.

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