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 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/sterile.

The proposed devices are three-layer, flat pleated masks. A mask is composed of a mask body, a nose piece, two ear loops and two side tapes. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are knitted elastic loops (made of polyester and spandex). The nose piece is in the layers of face mask to allow the user to fit the face mask around their nose, which is a iron wire with polypropylene covering. In order to improve the wearing comfort, two side tapes are welded to the mask body along the width direction to cover the mask edges. The side tapes are made of spunbond polypropylene nonwoven fabric (the same material as the inner layer). The proposed device contains two models, and the structure, materials and dimensions of the two models are exactly the same except the status. Disposable Surgical Face Mask is provided non-sterile and Disposable Surgical Face Mask (Sterile) is provided sterile. They are both intended to be single use, disposable devices. The proposed devices can meet the requirements for the performance class of Level 3 specified in ASTM F2100.

This document primarily concerns the regulatory approval (510(k) clearance) of a medical device, specifically a Disposable Surgical Face Mask, by the FDA. The information provided heavily focuses on non-clinical performance testing against established standards, rather than the type of clinical study involving human-in-the-loop performance or expert consensus typically found in AI/CADe device submissions.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not available within this document because the device is a physical product (a face mask) and its evaluation relies on established material and performance standards, not on image interpretation or diagnostic algorithms.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for Disposable Surgical Face Mask

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the requirements for Level 3 as specified in ASTM F2100-19 and other relevant standards.

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

• Sample Size: For the performance tests (Fluid Resistance, BFE, PFE, Differential Pressure, Flammability), the document states "Statistics of three lots, 32 per lot," which means a total of 96 samples were tested for each performance criterion.
• Data Provenance: The document does not explicitly state the country of origin where the tests were performed, but the manufacturer is National Bridge Industrial (S.Z.) Co., Ltd. in China, and the submission correspondent is Shenzhen Joyantech Consulting Co. Ltd, also in China. These were non-clinical (laboratory) tests, not retrospective or prospective patient data studies.

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

• Not Applicable. The ground truth for this device (a surgical face mask) is established through standardized laboratory testing protocols (e.g., ASTM, EN, ISO standards) measuring physical properties like filtration efficiency and fluid resistance, not through expert human interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, the evaluation relies on objective, quantifiable measurements from laboratory tests, not subjective assessments requiring adjudication among experts.

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

• No. This type of study is relevant for diagnostic devices (e.g., AI algorithms for image interpretation) where human readers' performance is compared with and without AI assistance. This document describes the testing of a physical medical device (face mask).

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

• Not Applicable. This is not an algorithmic or software-based device. "Standalone" performance would refer to the device's inherent physical characteristics as measured by the non-clinical tests listed.

7. The Type of Ground Truth Used

• The "ground truth" for the surgical face mask is defined by established engineering and material performance standards (e.g., ASTM F2100-19, ASTM F1862, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993 for biocompatibility) and the test methodologies prescribed within them. These standards define the acceptable range or threshold for various physical and biological properties.

8. The Sample Size for the Training Set

• Not Applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. No training set was used.

Ask a specific question about this device