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510(k) Data Aggregation
(57 days)
The Medical Face Mask is intended to be worn to protect both the patient and healthcare persomel 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 Medical Face Mask (Model: M001) is available in white, blue and black colors, 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 user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. 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 Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the 510(k) premarket notification for a Medical Face Mask (Model: M001). This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K211631) through non-clinical performance testing and biocompatibility assessments, rather than AI/ML algorithm performance.
Therefore, many of the requested criteria related to AI/ML device performance (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size for training sets, etc.) are not applicable to this submission, as it pertains to a physical medical device (face mask) and not an AI-powered diagnostic or assistive technology.
Here's the information that can be extracted and a clear indication of what is not applicable:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose (Test) | 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. | Level 2: 29 out of 32 pass at 120 mmHg Level 3: 29 out of 32 pass at 160 mmHg | Level 2: 32 out of 32 per lot pass at 120 mmHg for 3 non-consecutive lots tested Level 3: 32 out of 32 per lot pass at 160 mmHg for 3 non-consecutive lots tested | 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% | Level 2: Average Result - 99.2% (3 non-consecutive lots tested, sample size 32/lot) Level 3: Average Result - 99.4% (3 non-consecutive lots tested, sample size 32/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% | Level 2: Average Result - 99.2% (3 non-consecutive lots tested, sample size 32/lot) Level 3: Average Result - 99.4% (3 non-consecutive lots tested, sample size 32/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 | Level 2: 4.4 mmH2O/cm² (3 non-consecutive lots tested, sample size 32/lot) Level 3: 5.1 mmH2O/cm² (3 non-consecutive lots tested, sample size 32/lot) | PASS |
| Flammability 16 CFR 1610 | Assess the resistance of a mask to ignition. | Class 1 | Level 2: Class 1 (3 non-consecutive lots tested, sample size 32/lot) Level 3: Class 1 (3 non-consecutive lots tested, sample size 32/lot) | PASS |
| Biocompatibility - Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material. | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Biocompatibility - Irritation | Assess the potential risk of Irritation of mask material. | Non-Irritating | Under the conditions of the study, the device is non-irritating. | PASS |
| Biocompatibility - Sensitization | Assess the potential risk of Sensitization of mask material. | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample size used for the test set and the data provenance
- Sample Size for performance testing: For each performance test (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability), 3 non-consecutive lots were tested, with a sample size of 32 units per lot.
- Data Provenance: The tests were conducted to verify the device's compliance with standards and requirements, implying the data originates from prospective testing specifically performed for this submission. The manufacturer is Xingyu Medical Tech Co., Ltd. located in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device (mask), not an AI/ML algorithm where expert ground truth is typically assessed for image interpretation or diagnosis. The "ground truth" for the mask is based on objective measurements against established technical standards (e.g., ASTM, EN, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is for a physical device, not an AI/ML diagnostic or assistive technology. Test results are objective measurements based on standards.
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
- No. This is a physical medical device (face mask). MRMC studies are relevant for AI/ML diagnostic or assistive technologies that interact with human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device. Standalone algorithm performance studies are relevant for AI/ML diagnostic or assistive technologies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on established industry standards and regulatory requirements for medical face masks (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). Performance is determined by meeting objective quantitative and qualitative criteria defined in these standards.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or AI/ML ground truth establishment is involved.
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