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510(k) Data Aggregation
(88 days)
The Surgical Face Mask 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 the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The Proposed device Surgical Face Mask (Model: MGSM-01) is blue color, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed 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. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear strap is made of Elastics Film. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene, iron and zinc. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
This document describes the premarket notification (510(k)) for a Surgical Face Mask. The device in question is a physical product (a face mask), not an AI/ML powered medical device or software. Therefore, the questions related to AI/ML specific criteria such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "ground truth establishment for training and test sets," and "number of experts" are not applicable.
Here's the information extracted from the provided text regarding the acceptance criteria and the study proving the device meets these criteria:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | ≥ 29 out of 32 pass at 120 mmHg for Level 2 | 32 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | Lot1: 99.04%, Lot2: 98.87%, Lot3: 98.88% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | ≥ 98% | Lot1: 98.9%, Lot2: 98.94%, Lot3: 99.04% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask | < 6.0 mmH2O/cm² | Lot1: 3.29 mmH2O/cm², Lot2: 3.59 mmH2O/cm², Lot3: 3.48 mmH2O/cm² | PASS |
| Flammability (16 CFR 1610) | Assess the resistance of a mask to ignition | Class 1 | Class 1 | PASS |
Biocompatibility Testing:
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material | Non-Cytotoxic | PASS (Under the conditions of the study, the device is non-cytotoxic.) |
| Irritation | Assess the potential risk of Irritation of mask material | Non-Irritating | PASS (Under the conditions of the study, the device is non-irritating.) |
| Sensitization | Assess the potential risk of Sensitization of mask material | Non-Sensitizing | PASS (Under the conditions of the study, the device is non-sensitizing.) |
2. Sample size used for the test set and the data provenance
For performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability):
- Sample size: 3 non-consecutive lots were tested. For each lot, a sample size of 32 was used for each respective test.
- Data Provenance: The document does not specify the country of origin of the labs performing the tests. The studies are non-clinical (laboratory tests), not human retrospective or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical product (surgical face mask) and the testing involves laboratory performance characteristics, not clinical assessment by experts for "ground truth" related to disease diagnosis or interpretation of medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This refers to adjudication of clinical ground truth, which is not relevant for this device's testing.
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
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device. The testing conducted was for the physical properties and performance of the mask itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by standardized laboratory testing methods (e.g., ASTM, EN, CFR standards). The acceptance criteria are derived from these established standards for surgical mask performance.
8. The sample size for the training set
Not applicable. This refers to AI/ML model training data, which is not relevant for this device.
9. How the ground truth for the training set was established
Not applicable. This refers to AI/ML model training data, which is not relevant for this device.
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