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510(k) Data Aggregation
(208 days)
The IFM Surgical Mask Model SM3 is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The IFM Surgical Mask Model SM3 is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, melt-blown, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene melt-spunbond, white). Each mask contains ear loops to secure the mask over the user's mouth and nose and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
This device is not made with natural rubber latex.
The document is a 510(k) Premarket Notification for the IFM Surgical Mask Model SM3. It asserts the substantial equivalence of the subject device to a predicate device, the 3M™ High Fluid-Resistant Procedure Mask (K191355, Model Number 1840).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are generally aligned with ASTM F2100 Level 3 performance standards, which are demonstrated through specific test methods.
| Test Parameter / Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance (IFM Surgical Mask Model SM3) | Predicate Device Performance (3M™ High Fluid-Resistant Procedure Mask, Model 1840) | Comparison |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% as per ASTM F2101 | ≥98% as per ASTM F2101 | Equal to predicate (meets or exceeds) |
| Particulate Filtration Efficiency (PFE) | ≥98% @ 0.1 micron as per ASTM F2299 | ≥98% @ 0.1 micron as per ASTM F2299 | Equal to predicate (meets or exceeds) |
| Fluid Resistance | 160 mm Hg as per ASTM F1862 | 160 mm Hg as per ASTM F1862 | Equal to predicate (meets or exceeds) |
| Differential Pressure (Delta-P) | < 5 mmH₂O/cm² as per EN 14683:2019, Annex C and ASTM F2100-19 | < 5 mmH₂O/cm² as per MIL-M36954C | Equal to predicate (meets or exceeds the standard for breathability) |
| Flammability | Class 1 (16 CFR 1610) | Class 1 (16 CFR 1610) | Equal to predicate (meets or exceeds) |
| Biocompatibility | Non-cytotoxic, non-irritant, non-sensitizer (ISO 10993-1, 10993-5, 10993-10) | Non-cytotoxic, non-irritant, non-sensitizer (ISO 10993-1, 10993-5, 10993-10) | Equal to predicate (meets criteria for biological safety) |
2. Sample size used for the test set and the data provenance:
- Particulate Filtration Efficiency (PFE): "Three lots passed"
- Fluid Resistance: "Three lots passed"
- Bacterial Filtration Efficiency (BFE): "Three lots passed"
- Differential Pressure: "Three lots passed"
- Flammability: "Three lots Passed."
- Biocompatibility: The text states "Under the conditions of the study the device was found..." for cytotoxicity, irritation, and sensitization, implying a test was conducted.
The provenance of the data (e.g., country of origin, retrospective or prospective) is not specified in the provided document. The studies were non-clinical, meaning they were laboratory-based tests rather than human studies.
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, not studies requiring expert interpretation of results, ground truth, or adjudication. The "ground truth" for these tests is the quantitative measurement against established standards (e.g., specific filtration percentages, pressure differentials).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the studies are non-clinical performance tests.
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 is not applicable. The device is a surgical mask, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a surgical mask.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical performance tests is the established industry or regulatory standard (e.g., ASTM F2100 Level 3 requirements for BFE, PFE, fluid resistance, differential pressure, flammability, and ISO 10993 series for biocompatibility). The tests measure the device's physical and biological properties against these pre-defined benchmarks.
8. The sample size for the training set:
This is not applicable as the device is a physical product (surgical mask) and not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
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