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510(k) Data Aggregation
(25 days)
The Disposable Surgical Face Masks are 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 is a single use, disposable device(s), provided non-sterile.
The subject device is a Blue color and Flat Pleated type mask, utilizing the Ear Loops for wearing, and has Nose Piece design for fitting the facemask around the nose. The subject device is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filters. The subject device is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the subject device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of metal core plastic (aluminum metal core inside of polypropylene). The subject device is sold non-sterile and is intended to be single use, disposable device.
The provided document describes the performance of a MIPLNI YK-244 Disposable Surgical Mask based on non-clinical performance testing. It does not contain information about a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding AI device studies cannot be extracted from this document.
However, I can provide the acceptance criteria and reported device performance for the surgical mask.
1. Table of Acceptance Criteria and Reported Device Performance (for the surgical mask):
| Test Item | Standards | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Dimensions | - | Mask Layer: Length: 17.5cm±0.5cm, Width: 9.5cm±0.5cm | Pass |
| Nose Piece: 3mm x 105 mm x 0.5mm | Pass | ||
| Ear loop: 2.8mm in diameter, 195mm in length | Pass | ||
| ASTM F2100 Level | ASTM F2100-19 | Level 3 | Pass |
| Fluid Resistance Performance | ASTM F1862 | 32 out of 32 pass at 160 mmHg | Pass LOT #YKWK20201108: 32/32 at 160 mmHgLOT #YKWK20201111: 32/32 at 160 mmHgLOT #YKWK20201120: 32/32 at 160 mmHg |
| Particulate Filtration Efficiency (PFE) | ASTM F2299 | ≥ 98% | Pass LOT #YKWK20201108: 32/32 99.9% ±0.1%LOT #YKWK20201111: 32/32 99.9% ±0.1%LOT #YKWK20201120: 32/32 99.9% ±0.1% |
| Bacterial Filtration Efficiency (BFE) | ASTM F2101 | ≥ 98% | Pass LOT #YKWK20201108: 32/32 99.9%LOT #YKWK20201111: 32/32 99.9%LOT #YKWK20201120: 32/32 99.9% |
| Differential Pressure (Delta P) | EN 14683:2019+AC:2019 Annex C | < 5.0 mmH2O/cm² | Pass LOT #YKWK20201108: < 3.6 mm H2O /cm² (20-22°C and 55-62% RH, Flow Rate: 8 L/min)LOT #YKWK20201111: < 4.0 mm H2O / cm² (20-22°C and 55-62% RH, Flow Rate: 8 L/min)LOT #YKWK20201120: < 4.0 mm H2O /cm² (20-22°C and 55-62% RH, Flow Rate: 8 L/min) |
| Flammability | 16 CFR 1610 | Class 1 | Pass LOT #YKWK20201108: IBELOT #YKWK20201111: IBELOT #YKWK20201120: IBE |
| In Vitro Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass |
| Skin Irritation | ISO 10993-10 | Non-irritating | Pass |
| Skin Sensitization | ISO 10993-10 | Non-sensitizing | Pass |
Since this document pertains to a surgical mask and not an AI device, the following points are not applicable and are not found in the provided text:
- 2. Sample sized used for the test set and the data provenance (for an AI device)
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for an AI device)
- 4. Adjudication method (for an AI device)
- 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
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- 7. The type of ground truth used (for an AI device)
- 8. The sample size for the training set (for an AI device)
- 9. How the ground truth for the training set was established (for an AI device)
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