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510(k) Data Aggregation
(218 days)
The Surgical 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 potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The surgical masks are three-layer, flat-pleated style mask with ear loops and nose clip design for fitting the mask around the nose and mouth. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of meltblown polypropylene. The ear loops are made of nylon and spandex and the nose clip is made of galvanized iron wire. The masks not made with natural rubber latex materials, and all materials are being used in currently marketed devices. The masks will be provided in blue and the model CR02-2 will be labeled to Level 2, the CRO2 will be labeled to Level 3. The masks are single-use, disposable devices, provided non-sterile.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Surgical Mask (Model: CR02-2, CR02).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The device performance is reported for two models, CR02-2 (Level 2) and CR02 (Level 3), conforming to ASTM F2100 standards.
| Test Item | Acceptance Criteria (Level 2) | Reported Device Performance (CR02-2) | Acceptance Criteria (Level 3) | Reported Device Performance (CR02) |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | Pass | ≥ 98% | Pass |
| Differential Pressure (Delta-P) | < 6.0 mm H2O/cm² | Pass | < 6.0 mm H2O/cm² | Pass |
| Particulate Filtration Efficiency (PFE) | ≥ 98% | Pass | ≥ 98% | Pass |
| Fluid Resistance | ≥ 120 mm Hg | Pass at 120 mm Hg | ≥ 160 mm Hg | Pass at 160 mm Hg |
| Flammability | Class 1 | Pass | Class 1 | Pass |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| Irritation | Non-irritating | Non-irritating | Non-irritating | Non-irritating |
| Sensitization | Non-sensitizing | Non-sensitizing | Non-sensitizing | Non-sensitizing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each performance test (e.g., number of masks tested for BFE, Delta-P, etc.). It only indicates that the tests were conducted and "Pass" results were obtained. The data provenance is not specified beyond the tests being performed as part of a 510(k) submission from a Chinese company (Foshan Xinbao Technology Co., Ltd. in China). There's no information on whether it was retrospective or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to this type of device and study. The testing involves standardized laboratory performance tests on the physical properties of the surgical masks, not diagnostic interpretation by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. The performance testing relies on objective measurements against established international standards (ASTM F2100, EN 14683, ISO 10993), not subjective human adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This is a medical device (surgical mask), not an AI-powered diagnostic or assistive technology that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study for an algorithm is not applicable to this device, as it is a physical medical device (surgical mask) and does not involve any algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical performance testing of the surgical masks is based on established objective laboratory test methods and corresponding international standards/criteria such as ASTM F2101-14 for BFE, EN 14683:2019 for Differential Pressure, ASTM F2299-03 for PFE, ASTM F1862/F1862M-17 for Fluid Resistance, 16 CFR Part 1610 for Flammability, and ISO 10993 series for Biocompatibility.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring model training.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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