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510(k) Data Aggregation
(195 days)
Surgical 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 face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Surgical 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 face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The surgical face masks are single use multi-laver masks with outer laver and inner laver of polypropylene spunbond that sandwich a meltblown polypropylene filter material. The surgical face mask includes malleable aluminum nosepiece that can be bent to contour the nose. The surgical face masks are held in place with ear loops made of polyester/Lycra.
The information provided describes the acceptance criteria and performance of a Surgical Face Mask (K202708), comparing it to a predicate device (K201729).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Predicate/Standard) | Reported Device Performance (K202708) | Outcome |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Fluid Resistant at 80 mmHg | Lot 20201013: Passed 80 mmHgLot 20201022: Passed 80 mmHgLot 20201105: Passed 80 mmHg | Meets |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | ≥ 95% | Lot 20201013: PASSED 99.866%Lot 20201022: PASSED 99.9784%Lot 20201105: PASSED 99.9879% | Meets (Exceeds) |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥ 95% | Lot 20201013: PASSED 99.9%Lot 20201022: PASSED 99.9%Lot 20201105: PASSED 99.9% | Meets (Exceeds) |
| Differential Pressure (EN 14683 Annex C) | < 5.0 mmH2O/cm² | Lot 20201013: Average 3.9 mmH2O/cm²Lot 20201022: Average 3.9 mmH2O/cm²Lot 20201105: Average 4.2 mmH2O/cm² | Meets |
| Flammability (16 CFR 1610) | Class 1 | Lot 20201013: IBE (Class 1)Lot 20201022: IBE (Class 1)Lot 20201105: IBE (Class 1) | Meets |
| Biocompatibility (Cytotoxicity) (ISO 10993-5) | No cytotoxicity | Non-cytotoxic | Meets |
| Biocompatibility (Sensitization) (ISO 10993-10) | No sensitization | Non-sensitizing | Meets |
| Biocompatibility (Irritation) (ISO 10993-10) | No irritation | Non-irritating | Meets |
2. Sample size used for the test set and the data provenance
The document references "32/32" or similar notations for the lots tested for PFE, BFE, and Fluid Resistance. This likely indicates that all 32 samples from each lot tested met the criteria for these specific tests. However, the precise definition of "sample" in this context (e.g., individual masks, or a batch from which tests are performed) and the overall sample size for each test (e.g. how many masks in total were subjected to fluid resistance) and lot are not explicitly stated in granular detail beyond the "32/32" type notation.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, although the manufacturer is INTCO Medical (HK) Co., Ltd.
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 device is a surgical face mask and the testing performed is for physical and biological properties in accordance with established ASTM, EN, and ISO standards, not for diagnostic accuracy requiring expert consensus.
4. Adjudication method for the test set
This information is not applicable as the evaluation is based on objective, standardized laboratory tests, not subjective interpretations requiring 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
This information is not applicable. The device is a surgical face mask, not an AI-powered diagnostic tool, and therefore no MRMC study was conducted.
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 AI-powered algorithm.
7. The type of ground truth used
The ground truth for the performance criteria is based on established industry standards and regulatory requirements (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683 Annex C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define the acceptable range or threshold for each performance characteristic.
8. The sample size for the training set
This information is not applicable. The device is a passive medical device (surgical face mask), not a machine learning model, so there is no training set in the AI sense.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
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