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510(k) Data Aggregation
(45 days)
The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is 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 surgical face mask is green color, and Flat Pleated type mask, utilizing Tie-On way for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical 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 a melt-blown polypropylene filter. The model of the proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spunbond polypropylene. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The surgical face masks are sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
The provided FDA 510(k) summary for the "Surgical Face Mask" (K202277) details performance testing against established acceptance criteria for medical face masks. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria for Level 2 Mask | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE, %) ASTM F2101 | ≥ 98% | ≥ 98% | Pass |
| Particulate Filtration Efficiency (PFE, at 0.1µm, %) ASTM F2299 | ≥ 98% | ≥ 98% | Pass |
| Differential Pressure (Delta P, mm H2O/cm²) ASTM F2100-19 EN 14683:2019, Annex C | < 6.0 | < 6.0 | Pass |
| Resistance to penetration by synthetic blood ASTM F1862/F1862M-17 | 29 out of 32 passes in ≥ 120 mmHg | ≥ 120 mmHg | Pass |
| Flame Spread 16 CFR 1610 | Class 1 Non-Flammable | Class 1 Non-Flammable | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each performance test. However, for "Resistance to penetration by synthetic blood," the acceptance criteria itself indicates a sample of 32 units (29 out of 32 passes). The provenance of the data is not specified (e.g., country of origin). The studies are non-clinical performance tests, not human participant studies, and are therefore not classified as retrospective or prospective in the typical medical research sense.
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 studies are non-clinical performance tests on a physical device. Ground truth, in the context of medical masks, is established by adherence to standardized testing protocols and objective measurement, not expert consensus in the interpretative sense.
4. Adjudication method for the test set:
This information is not applicable as the studies are non-clinical performance tests. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation or clinical outcome assessment by human experts.
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 information is not applicable. The device is a surgical face mask, and the evaluation involves manufacturing performance characteristics, not an AI or diagnostic application requiring human reader performance studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a surgical face mask, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the performance tests of the surgical face mask is based on objective measurements derived from standardized testing methods as defined by international and national standards such as ASTM F2100-19, ASTM F1862/F1862M-17, ASTM F2101-19, ASTM F2299-2003, EN 14683:2019 Annex C, and 16 CFR 1610. For biocompatibility, the ground truth is established by adherence to ISO 10993 series standards and the resultant "Pass" or "Non-cytotoxic," "Non-sensitizing," "Non-irritating" conclusions.
8. The sample size for the training set:
This information is not applicable. There is no "training set" in the context of physical medical device performance testing, as these are not machine learning or AI models.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set.
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