Search Results

The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood 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 Fluid Resistant Procedure Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Fluid Resistant Procedure Masks are manufactured with three layers. The outer layer is made of spun-bond polypropylene non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene non-woven fabric. The inner layer which contacts with face is made of spun-bond polypropylene non-woven fabric. The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.

The provided document is a 510(k) summary for a Disposable Surgical Mask/Fluid Resistant Procedure Mask. This document describes the device's technical specifications and non-clinical performance testing against established standards to demonstrate substantial equivalence to a predicate device. It does not involve AI or algorithms, so many of the requested categories (like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Training set sample size," and "Ground truth for training set") are not applicable.

Here's the summary of the acceptance criteria and study information found in the document:

1. Table of acceptance criteria and reported device performance:

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

• Sample size: For each performance testing (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), 32 samples from each of 3 non-consecutive lots were used, totaling 96 samples per test. Biocompatibility tests (Cytotoxicity, Skin Irritation, Skin Sensitization) also indicated testing was performed, with results confirming acceptance criteria, but specific sample sizes for these individual biocompatibility tests are not explicitly stated beyond "under the conditions of the study."
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It describes non-clinical performance tests conducted by the submitter to verify the device met design specifications.

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

• Not Applicable. This document describes non-clinical performance testing of a physical medical device (surgical masks) against established industry standards for material properties and performance. It does not involve expert interpretation or subjective evaluation typically associated with establishing ground truth for diagnostic or AI devices.

4. Adjudication method for the test set:

• Not Applicable. As per point 3, this is non-clinical device performance testing against objective standards, not a clinical study requiring adjudication of findings.

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-powered device or a study involving human readers.

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

• Not Applicable. This is not an algorithm or AI device. The testing describes the standalone performance of the physical surgical mask itself against specified metrics.

7. The type of ground truth used:

• The "ground truth" for the device's performance is based on established objective industry standards and testing methodologies (e.g., ASTM F1862M-17 for Fluid Resistance, ASTM F2299 for Particulate Filtration Efficiency, ISO 10993 for Biocompatibility). The device's performance is measured against the predefined acceptance criteria of these standards.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. This is not an AI/machine learning device.

Ask a specific question about this device