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510(k) Data Aggregation
(78 days)
The Motex Anti-Fog 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. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop, is flat pleated 3-ply device, which consists of four layers, i.e., Inner layer (Bicomponent thermal-bonded nonwoven, Polypropylene / Polyethylene, PP/PE), Filter layer (Polypropylene Melt-blown), Outer layer (Polypropylene Spunbond, blue/ green/ white/ pink color) and Anti-Fog films (EP coated Polyethylene). Each mask contains tie-on strips or elastic ear loops and of steel wire coated with Polyethylene resin to secure the mask fit over the user's mouth and nose. The dimensions of each mask are length 165±5 mm and width 95±2 mm.
The provided text describes the acceptance criteria and performance data for the Motex Anti-Fog Surgical Face Mask.
1. A table of acceptance criteria and the reported device performance
| Test item (Performance Level 3) | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Bacterial filtration efficiency | ≥ 98% | ≥99% | Pass |
| Differential pressure (Delta-P) | < 5 mm H2O/cm² | 2.6 mm H2O/cm² | Pass |
| Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres | ≥ 98% | 99.75% | Pass |
| Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result | Fluid resistant claimed at 80, 120, 160 mm Hg | Fluid Resistant claimed at 160 mm Hg | Pass |
| Flame spread | Class 1 | Class 1 | Pass |
| In vitro Cytotoxicity Test | Pass ISO 10993-5:2009 | Pass ISO 10993-5:2009 | Pass |
| Skin Sensitization Test | Pass ISO 10993-10:2010 | Pass ISO 10993-10:2010 | Pass |
| Skin Irritation Test | Pass ISO 10993-10:2010 | Pass ISO 10993-10:2010 | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of masks tested) for each non-clinical test. The tests are described as "Performance Testing summary" and "Biocompatibility Testing." Given the nature of these tests for medical devices, they were likely conducted in a controlled laboratory setting. The manufacturer is Modern Healthcare Corp., located in Hsin-Chu City, Taiwan. The provenance of the data is therefore Taiwan, and the tests were prospective in nature, performed to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation is based on non-clinical, objective performance tests (e.g., filtration efficiency, pressure differential, flame spread) and biocompatibility tests, not subjective expert assessment of images or medical cases.
4. Adjudication method for the test set
This information is not applicable as the evaluation is based on objective performance tests with predefined pass/fail criteria, not subjective human assessment requiring 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or image analysis, which is not the case for a surgical face mask.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance test for an algorithm was not done. This medical device is a physical product (a surgical face mask), not a software algorithm.
7. The type of ground truth used
The ground truth used for verifying the device's performance relies on objective measurements and standardized test methods. These include:
- ASTM F2101-14 for Bacterial filtration efficiency.
- MIL-M-36954C, Section 4.4.1.2 for Differential pressure.
- ASTM F2299-03 for Sub-micron particulate filtration efficiency.
- ASTM F1862-17 or ISO 22609:14 for Resistance to penetration by synthetic blood.
- 16 CFR Part 1610 for Flame spread.
- ISO 10993-5:2009 for In vitro Cytotoxicity Test.
- ISO 10993-10:2010 for Skin Sensitization Tests and Skin Irritation Tests.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device (surgical face mask), not a machine learning or AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
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