Search Results

The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided nonsterile.

The Surgical Face Masks are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of outer facing layer and inner facing layer. The colorant is blue polypropylene (PP) master batch.

The outer facing layer and inner facing layer of the mask are made of spun-bond polypropylene, the middle layer is made of melt blown polypropylene. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped aluminium.

The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Surgical Face Masks.

Please find below the acceptance criteria and study information based on the provided text.

Note: The provided document is a 510(k) Premarket Notification for a Surgical Face Mask. It details performance testing against established standards for physical properties and biocompatibility, not for a software-based AI/ML medical device. Therefore, many of the requested categories (e.g., sample size for test set with data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with humans, training set details) are not applicable to this type of device and the information is not present in the document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance

Biocompatibility Testing:

Study Details (Applicable sections based on a non-AI/ML medical device)

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

• Sample Size: The document provides acceptance criteria for tests like "29 out of 32 pass at 80 mmHg" for synthetic blood penetration, indicating a sample size of 32 for that specific test. For other tests (Bacterial Filtration Efficiency, Differential Pressure, Particulate Filtration Efficiency, Flammability, and Biocompatibility tests), the specific sample sizes used in testing are not explicitly stated within the public 510(k) summary, only the "Passed" result against the criteria.
• Data Provenance: Not specified, but generally, such testing is performed in laboratories according to the cited ASTM, EN, and ISO standards. The tests were performed as "Non-clinical Test Conclusion" and "Non-clinical Testing."
• Retrospective or Prospective: Not applicable as this refers to device performance testing against physical and chemical properties as per standards, not clinical data collection.

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

• Not Applicable. This is a physical device subject to standardized performance testing, not an AI/ML device requiring human expert ground truth for image interpretation or similar. The "truth" is established by the test methods and their defined pass/fail criteria.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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 is not an AI/ML medical device.

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

• Not Applicable. This is not an AI/ML medical device.

7. The type of ground truth used:

• For performance criteria (e.g., filtration efficiency, breathability, synthetic blood penetration, flammability), the "ground truth" is established by the specified international and national standards (ASTM, EN, CFR) and their associated validated test methodologies.
• For biocompatibility, the "ground truth" for safety is established by the ISO 10993 series of standards (ISO 10993-5 for Cytotoxicity, ISO 10993-10 for Sensitization and Irritation), specifically evaluating the biological response of the materials.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML medical device that uses a "training set."

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

• Not Applicable. See point 8.

Ask a specific question about this device