Search Results

The Medical 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(s), provided non-sterile.

The Medical Face 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 Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric. The Medical Face Masks are single use, disposable device, provided non-sterile.

The provided text describes the acceptance criteria and the study conducted for "Medical Face Masks" (K202627).

Here's the extracted information:

1. Table of Acceptance Criteria and Reported Device Performance:

   Methodology/Standard	Purpose	Acceptance Criteria	Reported Device Performance
   ASTM F1862M-17	Fluid Resistance Performance	29 out of 32 pass at 120mmHg	29 out of 32 pass at 120mmHg
   ASTM F2299	Particulate Filtration Efficiency	≥98%	Average 99.82% at 0.1μm
   ASTM F2101-19	Bacterial Filtration Efficiency	≥98%	Average 99.78%
   EN 14683:2019 Annex C	Differential Pressure	<6mmH2O/cm²	Average 3.3 mmH2O/cm²
   16 CFR 1610	Flammability	Class I Non Flammable	Meet Class I
   ISO 10993-5	In Vitro Cytotoxicity	Device is non-cytotoxic	Device is non-cytotoxic
   ISO 10993-10	Skin Irritation	Device is non-irritating	Device is non-irritating
   ISO 10993-10	Skin Sensitization	Device is non-sensitizing	Device is non-sensitizing

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

   • Fluid Resistance Performance (ASTM F1862M-17): The test involved 32 samples (29 out of 32 passed).
   • For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not explicitly stated in the provided text.
   • Data Provenance: Not specified, but the device manufacturer is based in China (Guilin HBM Sanitary Protections, Inc). The testing appears to be non-clinical laboratory testing.

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

   • Not applicable. These are non-clinical performance and material characterization tests, not reliant on expert clinical interpretation or ground truth establishment in the traditional sense of medical image analysis or diagnostic studies.

4. Adjudication method for the test set:

   • Not applicable. The tests are standardized laboratory procedures with objective measurements.

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 for a Medical Face Mask, not an AI diagnostic device. No MRMC study was conducted.

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

   • Not applicable. This is for a Medical Face Mask. The tests performed are standalone performance tests for the physical product.

7. The type of ground truth used:

   • The "ground truth" for these tests refers to established scientific and regulatory standards (e.g., ASTM, EN, 16 CFR, ISO standards) against which the device's physical properties and performance characteristics are measured. For example, for "Bacterial Filtration Efficiency," the ground truth is the specified bacterial filtration efficiency percentage (≥98%).

8. The sample size for the training set:

   • Not applicable. This is a medical device (face mask) and not an AI/ML algorithm that requires a training set.

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

   • Not applicable, as there is no training set for this device.

Ask a specific question about this device