Search Results

The Surgical face masks are 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 Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use. The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.

The provided document is a 510(k) premarket notification for a Surgical Face Mask. It details the device's technical specifications and comparative performance against a predicate device, primarily through non-clinical testing. It does not describe a study involving an AI/Machine Learning device or associated clinical performance evaluation. Therefore, I cannot provide information on acceptance criteria and study data related to AI/Machine Learning algorithm performance, ground truth establishment, expert adjudication, or MRMC studies.

However, I can extract the acceptance criteria and performance data for the physical properties and biological safety of the surgical face masks as presented in the document.

1. A table of acceptance criteria and the reported device performance for physical properties and biocompatibility:

The document presents performance data for both Level 2 and Level 3 surgical face mask models, as per ASTM F2100-19 standards. The testing was conducted on samples from "3 non-consecutive lots."

Table of Acceptance Criteria and Reported Device Performance (Surgical Face Mask - Physical and Biocompatibility Testing)

Note on Cytotoxicity: The comparison table explicitly states "Fail" for cytotoxicity, even though the reported result in the detailed performance tables states "show potential cytotoxicity" and a criterion of "Grade ≤ 2". This is a critical point of difference from the predicate device which was "not cytotoxic." The FDA's clearance likely implies that this difference did not raise new questions of safety or effectiveness given the overall risk-benefit profile for this type of device.

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

• Sample Size: For Flammability, Bacterial Filtration Efficiency, Differential Pressure, Sub-Micron Particle Filtration Efficiency, and Resistance to Penetration by Synthetic Blood, the testing was conducted on samples from "3 non-consecutive lots." The number of individual samples tested per lot is indicated for Flammability and Resistance to Penetration by Synthetic Blood, showing 32 out of 32 pass for flammability and ≥29 out of 32 pass for synthetic blood penetration. The exact sample sizes for BFE, Differential Pressure, and PFE for each lot are not explicitly stated as a count, but they are implied to be sufficient for generating the reported average percentages/values from the 3 lots.
• Data Provenance: The document does not specify the country of origin of the data. It is a submission from "Foshan Nanhai Plus Medical CO LTD" in China. The testing appears to be retrospective as it is presented as completed performance data for a device already manufactured.

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

• This is not applicable to the tests described. The "ground truth" for the performance tests (e.g., BFE, PFE) is established by the standardized testing protocols (e.g., ASTM F2100) and laboratory measurements, not by expert consensus or interpretation of images/clinical data. For biocompatibility, it's based on standard biological evaluation protocols (e.g., ISO 10993 series).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. The tests are laboratory-based measurements with defined pass/fail criteria, not subjective assessments requiring 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:

• Not applicable. This document pertains to a physical medical device (surgical face mask) and its performance characteristics, not an AI/Machine Learning algorithm. No MRMC study was conducted or is relevant to this device's evaluation.

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

• Not applicable. This document is for a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the device's performance is derived from standardized physical and chemical testing methods using established protocols (e.g., ASTM F2100 for filtration, differential pressure, flammability, synthetic blood penetration; ISO 10993 for biocompatibility). The results are quantitative measurements against predefined criteria.

8. The sample size for the training set:

• Not applicable. This is not an AI/Machine Learning device; thus, there is no "training set."

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

• Not applicable for the same reason as above.

Ask a specific question about this device