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510(k) Data Aggregation
(58 days)
The Disposable Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical 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 Proposed device(s) are blue color, and pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond 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 loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene ,metal wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (DF3-001) to verify its performance and safety.
1. Table of acceptance criteria and the reported device performance:
| Item | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance 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 160 mmHg for level 3 | Lot1, Lot2, Lot3: 32 out of 32 pass at 160 mmHg (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | 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: 99.35% Lot2: 99.46% Lot3: 98.69% (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | 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: 99.88% Lot2: 99.87% Lot3: 99.88% (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | 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: 4.13 mmH2O/cm² Lot2: 4.18 mmH2O/cm² Lot3: 4.24 mmH2O/cm² (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS |
| Flammability 16 CFR 1610 | Assess the resistance of a mask to ignition | Class I | Lot1, Lot2, Lot3: Class I (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS |
| Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Irritation | Assess the potential risk of Irritation of mask material | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization | Assess the potential risk of Sensitization of mask material | Non-Sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
For all performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability), the sample size used was 32 units per lot, across 3 non-consecutive lots.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the document is a 510(k) submission to the US FDA from a Chinese applicant (Wellmed Dental Medical Supply Co., Ltd. in Shenzhen, China), suggesting the tests were likely conducted by or for the manufacturer in China or by a certified lab for regulatory submission purposes. These are non-clinical (laboratory) tests performed specifically for regulatory approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a non-clinical, laboratory-based performance and biocompatibility study for a medical device (face mask). There is no "ground truth" in the clinical sense established by human experts like radiologists. The "ground truth" is determined by established scientific standards and test methods (e.g., ASTM, EN, ISO standards), with results measured by laboratory equipment and qualified personnel following those protocols. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically understood in AI/clinical studies does not apply here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a non-clinical, laboratory-based performance and biocompatibility study. Adjudication methods are typically relevant for human-interpreted data, such as medical images or clinical diagnoses.
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 a non-clinical study for a medical face mask. It does not involve human readers, AI, or clinical effectiveness studies in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical product (a face mask), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is defined by the objective, reproducible measurements against established performance standards and specifications outlined in the referenced international standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). The acceptance criteria for each test (e.g., "$\geq$ 98%," "< 6.0mmH2O/cm²") numerically define the acceptable performance.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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