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510(k) Data Aggregation
(96 days)
This single-use surgical mask EFXPLY3SMSK is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure of blood and body fluids. This is a single use, disposable device, non-sterile.
The device is a flat pleated type mask the outer layer being blue and the inner layer being white, utilizing ear loops to secure the mask in place, and a nose bridge is also incorporated for a proper fit around the nose. The device number is EFX3PLYSMSK.
The device is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, and the middle layer is made of melt-blown polypropylene filter material. The model EFX3PLYSMSK device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polypropylene and spandex. The nose bridge contained within the device is placed between the layers of the surgical mask to allow the user to fit the surgical mask properly around their nose. The nose bridge is made up of galvanized with polyethylene.
Here's a breakdown of the acceptance criteria and study information for the Disposable Surgical Face Mask, based on the provided document:
Acceptance Criteria and Device Performance
Level 3 Performance
| Test Methodology | Accepted Criteria (Level 3) | Reported Device Performance (EFX3PLYSMSK) | Result |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | 160mm Hg. | 95 of 96 samples passed | Pass |
| Particulate Filtration Efficiency ASTM F2299 | ≥98% | 99.79% Filtration average efficiency across 96 samples | Pass |
| Bacterial Filtration Efficiency ASTM F2101-19 | ≥98% | 99.8% Filtration average efficiency across 96 samples | Pass |
| Differential Pressure (Delta P) AMST F2100-19 | <6.0mm H2O /cm² | 3.56 mm H2O/cm² average pressure drop across 96 samples | Pass |
| Flammability 16 CFR 1610 | Class 1 | 96 of 96 samples did not ignite | Pass |
Level 2 Performance
| Test Methodology | Accepted Criteria (Level 2) | Reported Device Performance (EFX3PLYSMSK) | Result |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | 120mm Hg. | 96 of 96 samples passed | Pass |
| Particulate Filtration Efficiency ASTM F2299 | ≥98% | 99.79% Filtration average efficiency across 96 samples | Pass |
| Bacterial Filtration Efficiency ASTM F2101-19 | ≥98% | 99.8% Filtration average efficiency across 96 samples | Pass |
| Differential Pressure (Delta P) AMST F2100-19 | <6.0mm H2O /cm² | 3.56 mm H2O/cm² average pressure drop across 96 samples | Pass |
| Flammability 16 CFR 1610 | Class 1 | 96 of 96 samples did not ignite | Pass |
Biocompatibility
| Test Item | Accepted Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Cytotoxicity | No potential cytotoxicity | Under the conditions of the study, the device extract did not show potential toxicity to L 929 cells | Pass |
| Irritation | Non-irritating | Under the condition of the study, the device is non-irritating | Pass |
| Sensitization | Non-sensitizing | Under the conditions of the study, the device is non-sensitizing | Pass |
Study Information
Due to the nature of the device (Disposable Surgical Face Mask) and the provided document, much of the requested information regarding AI/software studies is not applicable. The document describes a non-clinical performance and biocompatibility study for a physical medical device, not an AI/software-based medical device.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: For performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), 96 samples of the device (EFX3PLYSMSK) were used for each test. For biocompatibility tests, the sample size is not explicitly stated in numerical terms (e.g., number of test articles), but the results indicate testing was performed.
- Data Provenance: The document does not specify the country of origin of the data directly, nor does it explicitly state whether the study was retrospective or prospective. Given these are physical performance tests, it's generally implied to be a prospective laboratory study on newly manufactured samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of study. "Ground truth" established by experts typically pertains to diagnostic accuracy studies involving image interpretation or clinical assessments, which are not relevant to the physical performance testing of a surgical mask. The acceptance criteria themselves serve as the 'ground truth' for performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable to this type of study. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, not for objective physical performance testing against predefined criteria.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic accuracy of AI systems, often in comparison to human reader performance, which is not relevant for a surgical mask.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. As this is a physical medical device (surgical mask), there is no AI algorithm involved.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study is based on established regulatory standards and test methodologies (e.g., ASTM F1862, ASTM F2299, ASTM F2101-19, AMST F2100-19, 16 CFR 1610, ISO 10993-5, ISO 10993-10). The performance of the mask is measured against quantitative and qualitative acceptance criteria specified by these standards for surgical masks.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The samples used for testing are production samples of the device.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth establishment for it.
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