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510(k) Data Aggregation
(86 days)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical masks are 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 subject Disposable Surgical Face Masks have two model: FM-34EE, Level 2 and Model: FM-44EE, Level 3.
The Disposable Surgical Face Masks (Model: FM-34EE, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-34EE mask are made of spun-bond polypropylene, the middle layer is made of melt-blown polypropylene.
The Disposable Surgical Face Masks (Model: FM-44EE, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, filtration layer and outer layer. The colorant is polypropylene (PP) master batch.
The inner layer and outer layer of FM-44EE are made of spun-bonded polypropylene, the second layer is made of PE film, the filtration layer is made of melt-blown polypropylene.
The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of aluminum.
The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
The acceptance criteria and study proving the device meets them are detailed below, based on the provided text.
The device in question is the "Disposable Surgical Face Masks (FM-34EE, FM-44EE)".
1. Table of Acceptance Criteria and Reported Device Performance
The device includes two models: FM-34EE (Level 2) and FM-44EE (Level 3). The acceptance criteria and performance are outlined for both levels where applicable.
| Performance Testing | Test Methodology | Acceptance Criteria for Level 2 Barrier | Acceptance Criteria for Level 3 Barrier | Reported Performance (Result for both Levels) |
|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101 | $\geq$ 98% | $\geq$ 98% | Passed (Level 2: average 99.9%, Level 3: average 99.9%) |
| Differential Pressure (mmH2O/cm²) | EN 14683:2019 Annex C | $<$ 6.0 mmH2O/cm² | $<$ 6.0 mmH2O/cm² | Passed (Level 2: average 3.45 mmH2O/cm², Level 3: average 3.65 mmH2O/cm²) |
| Sub-micron Particulate Filtration Efficiency | ASTM F2299-17 | $\geq$ 98% | $\geq$ 98% | Passed (Level 2: average 98.43%, Level 3: average 98.56%) |
| Resistance to Penetration by Synthetic Blood | ASTM F1862-17 | 120 mmHg | 160 mmHg | Passed (Level 2: Pass at 120mmHg, Level 3: Pass at 160mmHg) |
| Flammability | 16 CFR Part 1610-2008 | Class I | Class I | Passed (Class 1) |
| Biocompatibility: Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic | Passed (Non-cytotoxic) |
| Biocompatibility: Sensitization | ISO 10993-10 | Non-sensitizing | Non-sensitizing | Passed (Non-sensitizing) |
| Biocompatibility: Irritation | ISO 10993-10 | Negligibly irritating | Negligibly irritating | Passed (Negligibly irritating) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test set (e.g., number of masks tested for BFE, differential pressure, etc.). It only indicates that "The Disposable Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document...".
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer or a contracted testing facility to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a surgical face mask, and "ground truth" as typically used in AI/image analysis studies (e.g., expert consensus on medical images) is not relevant here. The performance evaluation relies on standardized laboratory test methods for physical and biological properties.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments. For the laboratory-based performance testing of the surgical face mask, no such adjudication method is mentioned or expected. The tests follow established scientific protocols with measurable outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. Surgical masks are evaluated based on their physical and biological barrier properties, not on human reader performance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, this pertains to an AI/algorithm-based device, which this surgical face mask is not. The performance is the inherent protective capability of the physical mask itself, evaluated through laboratory testing.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective, standardized laboratory test methods outlined by organizations like ASTM and ISO, and FDA guidance. These methods provide quantifiable measurements of bacterial filtration efficiency, particulate filtration efficiency, differential pressure, fluid resistance, flammability, and biocompatibility. There is no expert consensus, pathology, or outcomes data used as ground truth in the context of device performance assessment for this type of product.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical face mask), not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical device like a surgical face mask.
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