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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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