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510(k) Data Aggregation
(88 days)
The Disposable surgical masks are intended to be worn to protect 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 Disposable surgical masks are single use, three-layer, flat - folded masks with ear loops and nose piece. The Disposable surgical masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric (polypropylene), and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of spandex wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document describes the FDA 510(k) clearance for a "Disposable surgical mask" (K220532), demonstrating its substantial equivalence to a predicate device. The clearance is based on non-clinical performance testing.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 3 non-consecutive lots tested: All passed (implied) | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot1: 98.43%, Lot2: 98.18%, Lot3: 98.54% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot1: 99.9%, Lot2: 99.9%, Lot3: 99.9% | Pass |
| Differential Pressure (MIL-M-36954C) | < 5.0mmH2O/cm² | Lot1: 3.5mmH2O/cm², Lot2: 3.1mmH2O/cm², Lot3: 3.3mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Pass |
| Irritation | Non-irritating | Under the conditions of the study, the device is non-irritating | Pass |
| Sensitization | Non-sensitizing | Under the conditions of the study, the device is non-sensitizing | Pass |
| Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic | Pass |
2. Sample sized used for the test set and the data provenance
- Sample Size: For Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure, "3 non-consecutive lots tested" were used. The number of individual masks tested within each lot is not specified, except for Fluid Resistance where "29 out of 32" suggests 32 samples were tested per lot for that specific test.
- Data Provenance: The tests were conducted by the manufacturer, Xiamen Blue Star Enterprise Co., Ltd., China. The document does not specify if the data is retrospective or prospective, but it's generated for the purpose of this 510(k) submission, suggesting it's newly generated for regulatory approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this document. The device in question is a physical product (surgical mask), and its performance is evaluated through standardized laboratory tests (e.g., filtration efficiency, fluid resistance) rather than through expert interpretation of medical images or other data where a "ground truth" would be established by human experts. The "ground truth" here is the objective measurement of the physical properties of the mask.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reading images) where discrepancies need to be resolved. This document details laboratory performance testing of a physical product.
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
This section is not applicable. This document describes the clearance of a physical medical device (surgical mask), not an AI-assisted diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective, standardized laboratory test methods. Examples include:
- ASTM F1862 for fluid resistance.
- ASTM F2299 for particulate filtration efficiency.
- ASTM F2101 for bacterial filtration efficiency.
- MIL-M-36954C (or EN 14683) for differential pressure.
- 16 CFR 1610 for flammability.
- ISO 10993-5 and -10 for biocompatibility (irritation, sensitization, cytotoxicity).
8. The sample size for the training set
This section is not applicable. A "training set" refers to data used to train machine learning models. This document describes a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
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