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510(k) Data Aggregation
(169 days)
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
The surgical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spun-bond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
This document pertains to the 510(k) premarket notification for a Disposable Surgical Mask (K203756). The study described focuses on the device's functional performance and biocompatibility rather than human-in-the-loop performance with an AI. Therefore, the questions related to AI assistance, human reader improvement, multi-reader multi-case studies, and ground truth establishment from expert consensus for AI training are not applicable to the context of this traditional medical device submission.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the device's performance evaluation is found in the "Summary of Non-clinical Testing" section, specifically in the table on page 8.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | To evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of high-velocity stream of synthetic blood. Pass/fail determinations are based on visual detection of synthetic blood penetration. | 29 Out of 32 pass at 160 mmHg | Lot 1: 32 Out of 32 pass at 160 mmHgLot 2: 32 Out of 32 pass at 160 mmHgLot 3: 32 Out of 32 pass at 160 mmHgResult: Pass |
| Particulate Filtration Efficiency (ASTM F2299) | To measure the initial particulate filtration efficiency of materials using monodispersed aerosols containing suspended latex spheres particulates of 0.1μm diameter. | ≥ 98% | Lot 1: 99.8%Lot 2: 99.9%Lot 3: 99.9%Result: Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | To determine the bacterial filtration efficiency of the mask. | ≥ 98% | Lot 1: > 99.9%Lot 2: > 99.9%Lot 3: > 99.9%Result: Pass |
| Differential Pressure (EN 14683:2019) | To measure the differential pressure between the inside and outside of the mask. | < 6.0 mmH2O/cm² | Lot 1: 3.4 mmH2O/cm²Lot 2: 3.5 mmH2O/cm²Lot 3: 3.3 mmH2O/cm²Result: Pass |
| Flammability (16 CFR 1610) | To determine the flammability characteristics of the mask. Materials shall meet requirements for Class 1 (normal flammability). | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1Result: Pass |
| Cytotoxicity (ISO 10993-5) | To determine the biological reactivity of a mammalian cell culture (mouse fibroblast L929 cells) in response to the test article. | Non-Cytotoxic | Under the conditions of the study, non-cytotoxicity effect |
| Irritation (ISO 10993-10) | To evaluate the potential skin irritation caused by the extraction of the test article extract contacting with the skin surface of rabbits. | Non-Irritating | Under the conditions of the study, non-irritation |
| Sensitization (ISO 10993-10) | To evaluate the potential of test article extracts to cause skin sensitization in the guinea pig according to GPMT method. | Non-Sensitizing | Under the conditions of the study, non-sensitization |
2. Sample Size Used for the Test Set and Data Provenance
For the performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), results are reported for 3 lots of the disposable surgical mask. Specific sample sizes within each lot for individual tests are provided where applicable (e.g., 32 out of 32 for Fluid Resistance).
The data provenance is from non-clinical testing, likely conducted by the manufacturer or a contracted lab in China, given the manufacturer's location (Yixing, Jiangsu, China). The data is by nature prospective, as it was generated specifically for this 510(k) submission to demonstrate compliance with performance and biocompatibility standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is for a traditional medical device (surgical mask), not an AI device requiring ground truth established by expert medical reviewers. The "ground truth" for the device's performance is established by standardized, objective laboratory test methods (e.g., ASTM, EN, ISO standards), which measure physical and biological properties.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is based on objective laboratory measurements according to established standards, there is no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a submission for a physical medical device (surgical mask), not an AI-assisted diagnostic or treatment system. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for a non-AI physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this medical device is based on objective, quantitative measurements performed according to recognized international and national standards. This includes:
- Physical Performance Data: Measured values for fluid resistance, particulate filtration efficiency, bacterial filtration efficiency, differential pressure, and flammability.
- Biocompatibility Data: Results from in vitro cytotoxicity tests and in vivo irritation and sensitization tests (using animal models, specifically rabbits and guinea pigs).
These standards define the acceptable range or threshold for each performance characteristic, effectively serving as the "ground truth" for the device's safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The device's performance is based on its physical design and materials, which are verified through the non-clinical tests described.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant to this submission.
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