Search Results

The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.

The medical face mask is designed and manufactured by Jiangsu Province Jianerkang Medical Dressing Co., Ltd. It is non-sterile and for single use. The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from steel wire. It is a self-inhalation filter mask, which works by filtering the air containing microorganisms, body fluids, and particulate matters through the filter material of the mask before being inhaled or exhaled. The product is level 1 according to ASTM F2100-19.

The document describes the acceptance criteria and performance data for a Medical Face Mask (K202061).

1. Table of Acceptance Criteria and Reported Device Performance:

Note: While the device is classified as Level 1 according to ASTM F2100-19 in the device description, the performance data often reports results that meet Level 3 criteria, indicating a higher performance than the minimum required for Level 1 for those specific tests.

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

• The document does not explicitly state the sample size used for each performance or biocompatibility test.
• The data provenance is from Jiangsu Province Jianerkang Medical Dressing Co., Ltd. in China. The data is retrospective, collected during the device's development and testing to support the 510(k) submission.

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

• This information is not applicable as the document describes performance testing for a medical face mask, not an AI/ML-based diagnostic device requiring expert interpretation for ground truth. The acceptance criteria are based on established international and national standards (ASTM, ISO, CFR).

4. Adjudication method for the test set:

• This information is not applicable for the same reason as point 3. Testing is based on objective, standardized laboratory methods rather than subjective expert adjudication.

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 information is not applicable. The device is a medical face mask, not an AI-assisted diagnostic tool.

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

• This information is not applicable. The device is a medical face mask, not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" for the device's performance is established by adherence to internationally recognized standards and test methods. For example, Flammability is tested per ASTM F2100-19 and 16 CFR Part 1610-2008. BFE is tested per ASTM F2101-2019. Biocompatibility is tested per ISO 10993 series. These standards define the objective measurements and criteria for performance.

8. The sample size for the training set:

• This information is not applicable. The device is a physical medical face mask, not a machine learning model that requires a training set.

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

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

Ask a specific question about this device