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510(k) Data Aggregation
(49 days)
The Disposable 4 layers surgical face mask is intended to be worn by adults, and protects both patients and healthcare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment. The mask is designed for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single-use, disposable device(s) , provided non-sterile.
The WellBefore 4 Layers disposable surgical mask is an adult-sized surgical mask equipped with earloops, designed to cower the user's nose and mouth. The surgical face masks are consists of Outer Layer(Non-woven fabric made from spunbond polypropylene), Second Layer(meltblown filtration fabric made from polypropylene), Third Layer(Electrostastic cotton made from ethylene-propylene side by side), Inner Layer(Non-woven fabric made from spunbond polypropylene), Nose Bridge(Double-wirenosepinmade by polypropylene, and Earloops(Polyster Fiber and Spandex). The mask acts as a physical barrier from fuids and particulate materials, and providing a level 3 barrier. It is a single-use, disposable device(s) , provided non-sterile.
Here's a breakdown of the acceptance criteria and study information for the Disposable 4 layers surgical face mask based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Requirement (Acceptance Criteria) | Test Method | Reported Device Performance (Proposed Device) | Outcome |
|---|---|---|---|
| Fluid Resistance: $\ge 29$ out of 32 pass at 160mmHg (level 3) | ASTM F1862 | At least 29 out of 32 passing at 160mmHg | Pass |
| Particulate Filtration Efficiency: $\ge 98%$ | ASTM F2299 | $\ge 98%$ | Pass |
| Bacterial Filtration Efficiency: $\ge 98%$ | ASTM F2101 | $99.9%$ | Pass |
| Differential Pressure (Delta P): $< 6.0$ mmH2O/cm$^2$ | EN 14683:2019, Annex C | $< 6.0$ mmH2O/cm$^2$ | Pass |
| Flammability: Class 1 (Non Flammable) | 16 CFR 1610 | Class 1 (Non Flammable) | Pass |
| Biocompatibility: Non-cytotoxic, non-irritating, non-sensitizing | ISO 10993-5, ISO 10993-10 | Met ISO10993 (proved non-cytotoxicity, non-irritating, and non-sensitizing) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For performance testing (Fluid Resistance, PFE, BFE, Differential Pressure), three lots of the device were tested. Specific sample sizes within each test are mentioned (e.g., 32 for Fluid Resistance), but a total number of individual masks tested across all lots is not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data for these performance tests. It states that the tests were performed by "lab bench testing." The manufacturer is located in China (Jiangxi Xianmiyan Medical Technology Co., Itd).
- Retrospective or Prospective: The device testing appears to be prospective as it was conducted specifically for this 510(k) submission to demonstrate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable as the tests described are performance and material characteristic tests (bench testing) and not based on expert-established ground truth.
4. Adjudication Method for the Test Set
This is not applicable for bench testing. The results are quantitative measurements against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study (MRMC) is relevant for AI/imaging devices involving human interpretation. This document pertains to a surgical face mask, which does not involve human readers or AI assistance in its primary function or evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is not applicable for a surgical face mask.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by the specified performance requirements and test methods outlined in recognized standards such as ASTM F2100-19, EN 14683:2019, 16 CFR 1610, and ISO 10993 series. These standards define the expected performance metrics (e.g., filtration efficiency percentages, pressure differential limits) and the laboratory procedures for measuring them.
8. The Sample Size for the Training Set
Not applicable. There is no AI or algorithm involved in this medical device that would require 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.
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