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510(k) Data Aggregation
(232 days)
The medical surgery mask mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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 medical surgery mask is pleated three-layer mask with ear loops and nose piece. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric. The medical surgery mask is only the outer layers' color is blue (colorant: Pigment Blue 15:3/Model:147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the medical surgery mask.The inner layer is white. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the medical surgery mask is in the middle layer of medical surgery mask to allow the user to fit the medical surgery mask around their noses, which is made of malleable aluminum wire.
The dimensions of each medical surgery mask are length 175±5 mm and width 95±5 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm. The mask model 2626-7 meets level 3 performance requirements in ASTM F2100.The medical surgery masks are sold non-sterile and are intended to be single use,disposable devices.
The provided text describes the acceptance criteria and the study that proves a medical surgery mask meets these criteria, specifically for a 510(k) premarket notification (K220067) for the Medical Surgery Mask, Model: 2626-7.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Item (Performance Level 3) | Acceptance Criteria (Level 3) | Reported Device Performance (Model 2626-7) | Verdict |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) ASTM F2101-19 | BFE ≥ 98% | Lot A: 99.72%, Lot B: 99.82%, Lot C: 99.94% | Pass |
| Differential pressure (Delta-P) EN 14683:2019, Annex C | Delta-P < 6.0 mmH2O/cm² | Lot A: 1.86 mmH2O/cm², Lot B: 1.87 mmH2O/cm², Lot C: 1.86 mmH2O/cm² | Pass |
| Sub-micron particulate filtration efficiency at 0.1 micron ASTM F2299 | PFE ≥ 98% | Lot A: 99.34%, Lot B: 99.56%, Lot C: 99.33% | Pass |
| Resistance to penetration by synthetic blood ASTM F1862 | Fluid resistant claimed at 160 mmHg | 32 out of 32 per lot pass at 160 mmHg | Pass |
| Flame spread 16 CFR Part 1610 | Class 1 | Class 1 | Pass |
| Biocompatibility: Cytotoxicity (ISO 10993-5:2009) | Noncytotoxic | Under the conditions of the study, the device is noncytotoxic. | Pass |
| Biocompatibility: Irritation (ISO 10993-10:2010) | Nonirritating | Under the conditions of the study, the device is nonirritating. | Pass |
| Biocompatibility: Sensitization (ISO 10993-10:2010) | Nonsensitizing | Under the conditions of the study, the device is nonsensitizing. | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state a consolidated "sample size" for the entire test set. Instead, it refers to multiple lots (Lot A, B, C) for filtration and differential pressure tests, and "32 out of 32 per lot" for synthetic blood penetration. This implies that for each test, specific sample sizes were used per the respective standard's requirements.
- Data Provenance: The tests are "Non-Clinical Tests Performed" by the applicant, Dongguan Missadola Technology Co., Ltd. The document does not specify the country of origin of the raw data, but the manufacturer is based in China. The data provenance is retrospective in the sense that these tests were performed and compiled for the 510(k) submission, not as part of a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the "ground truth" for this medical device (a surgical mask) is established through adherence to recognized international and national performance standards (ASTM, EN, ISO, CFR), not through expert consensus on medical images or clinical outcomes. The tests measured physical and biological properties of the mask.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where there might be disagreement among experts. For performance testing of a physical product against objective standards, the results are typically quantitative and directly compared against the established criteria, not subject to human adjudication for "ground truth."
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 type of study (MRMC, AI assistance) is not applicable to a surgical mask. It's relevant for AI-powered diagnostic tools where human interpretation is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance tests (BFE, Delta-P, PFE, synthetic blood penetration, flammability, biocompatibility) are "standalone" in the sense that they measure the intrinsic performance of the mask itself, without human interaction with the device for its primary intended function (i.e., it's not a diagnostic tool where a human interprets algorithmic output). These are direct measurements of the product's physical and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is established by objective performance standards and laboratory test methods (e.g., ASTM F2101 for BFE, EN 14683 for differential pressure, ISO 10993 for biocompatibility). These standards define the acceptable range for each critical performance parameter for a Level 3 surgical mask.
8. The sample size for the training set:
- Not applicable. This device is a physical product (surgical mask), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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