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510(k) Data Aggregation
(59 days)
The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is 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 Medical Surgical Masks are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch. The inner layer and outer layer of the mask are made of non-woven fabric (polypropylene), the middle layer is made of melt-blown fabric (polypropylene). The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with polyamide and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped galvanized soft wire. The Medical Surgical Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
This document is a 510(k) premarket notification for a Medical Surgical Mask (Planar type). It focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA. The performance data presented is for the device itself, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML clinical studies are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a Medical Surgical Mask, and its performance is evaluated against parameters specified in medical device standards such as ASTM F2100. The acceptance criteria and reported performance are for the physical properties and barrier effectiveness of the mask.
| Test Methodology | Purpose | Acceptance Criteria (for Level 3 Barrier) | Reported Device Performance (for 3 non-consecutive lots, sample size 32/lot) |
|---|---|---|---|
| Bacterial Filtration Efficiency (ASTM F2101) | Measure bacterial filtration efficiency | ≥98% | Passed: Lot 1: ≥98%, Lot 2: ≥98%, Lot 3: ≥98% |
| Differential Pressure (mmH2O/cm²) (EN 14683:2019 Annex C) | Determine breathability of the mask | <6.0 mmH2O/cm² | Passed: Lot 1: <6.0, Lot 2: <6.0, Lot 3: <6.0 |
| Sub-micron Particulate Filtration Efficiency (ASTM F2299-17) | Measure initial particle filtration efficiency | ≥98% | Passed: Lot 1: ≥98%, Lot 2: ≥98%, Lot 3: ≥98% |
| Resistance to Penetration by Synthetic Blood (ASTM F1862-17) | Evaluate the resistance to penetration by impact of small volume of synthetic blood | 29 out of 32 pass at 160 mmHg | Passed: Lot 1: 32 out of 32 pass at 160 mmHg, Lot 2: 32 out of 32 pass at 160 mmHg, Lot 3: 32 out of 32 pass at 160 mmHg |
| Flammability (16 CFR Part 1610-2008) | Response of materials to heat and flame | Class I | Passed: Lot 1: Class 1, Lot 2: Class 1, Lot 3: Class 1 |
| Cytotoxicity (ISO 10993-05) | Assess the potential risk of cytotoxicity of mask material | Non-cytotoxic | Pass: Under the condition of this study, the device has no potential toxicity. |
| Irritation (ISO 10993-10) | Assess the potential risk of irritation of mask material | Negligibly irritating | Pass: Under the condition of this study, the device is negligibly irritating. |
| Sensitization (ISO 10993-10) | 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
The sample size for performance testing was 32 units per lot, across 3 non-consecutive lots. This makes a total of 96 units tested for each performance characteristic.
Data provenance is from non-clinical tests conducted by Hunan Chopard Medical Devices Co., Ltd., based in Hunan Province, China. The tests are retrospective to the manufacturing process, as they are performed on finished product lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The tests are laboratory-based measurements of physical and biological properties.
4. Adjudication method for the test set
Not applicable. There is no expert adjudication for these non-clinical, objective tests. The results are quantitative measurements against predefined criteria.
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/ML device, and no human reader studies or MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for the device's performance is established by validated laboratory testing methods against published international and national standards (e.g., ASTM F2101, EN 14683, ASTM F1862, ISO 10993). These standards define objective, measurable criteria for the performance of medical surgical masks.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML component, there is no training set or ground truth in that context.
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