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510(k) Data Aggregation
(174 days)
The Disposable 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 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 proposed devices are single use, three-layer, flat masks with ear loops and nose piece. The Disposable Medical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The proposed device, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene with steel wire. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) summary for the Wanxinda (Guangzhou) Technology Product Co., Ltd's Disposable Medical Face Mask. It details the device's characteristics, intended use, and a comparison with a predicate device to demonstrate substantial equivalence.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100-19 standard for Level 1 classification.
| Performance Metric | Acceptance Criteria (ASTM F2100 Level 1) | Reported Device Performance (Disposable Medical Face Mask) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 80 mmHg | Pass at 80 mmHg |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | $\geq$ 0.1 microns, $\geq$ 95% | 99.8% |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | $\geq$ 3.0 microns, $\geq$ 95% | 99.8% |
| Differential Pressure (EN 14683) | $<\text{5.0 mm H2O/cm}^2$ | $<\text{5.0 mm H2O/cm}^2$ |
| Flammability (16CFR 1610) | Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic |
| Irritation (ISO 10993-10) | Non-irritating | Non-irritating |
| Sensitization (ISO 10993-10) | Non-sensitizing | Non-sensitizing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific bench test performed. However, it mentions that the tests were conducted according to the listed standards (ASTM F2100-19, ISO 10993-1, ISO 10993-5, ISO 10993-10). These standards typically specify the number of samples required for testing.
The data provenance is not specified in terms of country of origin but is from non-clinical (bench) testing performed by the manufacturer to support the 510(k) submission. All provided information refers to the manufacturer's own testing for their device. The studies are retrospective as they present results of tests performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical face mask, and its performance is evaluated through standardized bench testing (physical, chemical, and biological properties) against established standards rather than through subjective expert assessment of images or clinical outcomes. The "ground truth" for the test set is defined by the requirements of the ASTM and ISO standards themselves.
4. Adjudication Method for the Test Set
Not applicable. As noted above, performance is assessed against objective, quantifiable metrics defined by international standards (ASTM and ISO). There is no "adjudication" in the sense of expert review for consensus; rather, the test results either meet or do not meet the predefined numerical criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human reader performance is a key factor. This document pertains to a physical medical device (face mask) evaluated through bench testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is not an algorithm or AI system. It is a physical medical device. The "standalone" performance here refers to the device's physical and biological properties as measured by bench tests, without human intervention in its function (beyond wearing it).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance relies on objective, quantifiable measurements derived from recognized international standards and protocols. Specifically:
- Physical performance (fluid resistance, filtration efficiency, differential pressure, flammability) is determined by the results of tests conducted according to ASTM standards (F1862, F2299, F2101, 16CFR 1610) and EN 14683.
- Biocompatibility (cytotoxicity, irritation, sensitization) is determined by the results of tests conducted according to ISO 10993-5 and ISO 10993-10 standards.
8. The Sample Size for the Training Set
Not applicable. The disposable medical face mask is a physical device, not an AI or machine learning model 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 a physical medical device like a face mask.
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