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510(k) Data Aggregation
(172 days)
The 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 Surgical Face Mask is designed and manufactured by Zhuhai Gaoge Medical Technology Co., Ltd. It is non-sterile and for single use. The Surgical Face Mask has one model, GK103, that is the ear-loop style. It is made of three-layer nonwovens, ear loops and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The ear loops are made of polyester. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of iron wire wrapped with plastic. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled. The product is level 2 according to ASTM F2100-19.
This is a 510(k) summary for a Surgical Face Mask (Model GK103). The document demonstrates substantial equivalence to a predicate device (K153496, Disposable Surgical Face Mask).
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Item & Test Methods | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flammability (ASTM F2100-19, 16 CFR 1610-2008) | Class 1 (ASTM F2100) | Pass (Class 1, Non-Flammable) |
| Bacterial Filtration Efficiency (BFE) (ASTM F2100-2019 9.1, ASTM F2101-2019) | Level 2: ≥ 98% (ASTM F2100) | Pass (average at 99.9%) |
| Differential Pressure (Delta P) (ASTM F2100-19 9.2) | Level 2: < 6.0 mm H2O/cm² (ASTM F2100) | Pass (average at 3.7 mm H2O/cm²) |
| Sub-Micron Particle Filtration Efficiency (ASTM F2100-2019 9.3, ASTM F2299/F2299M-2017) | Level 2: ≥ 98% (ASTM F2100) | Pass (average at 98.76%) |
| Resistance to Penetration by Synthetic Blood (ASTM F2100-2019 9.4, ASTM F1862/F1862-2017) | Level 2: pass at 120 mmHg (ASTM F2100) | Pass (32 out of 32 pass at 120 mmHg) |
Regarding Biocompatibility (ISO 10993-1:2018):
- Cytotoxicity: Not cytotoxicity effect.
- Sensitization: Not a sensitizer.
- Irritation: Not an irritant.
2. Sample size used for the test set and the data provenance
The document states for the performance tests (BFE, Differential Pressure, Sub-Micron Particle Filtration Efficiency, Resistance to Penetration by Synthetic Blood, Flammability) that the tests were conducted "For 3 non-consecutive lots, 32 out of 32 pass". This implies a sample size of 32 units per lot for a total of 96 units across three lots for these specific tests.
The data provenance is not explicitly stated in terms of country of origin of the data or being retrospective/prospective. However, given that the manufacturer is Zhuhai Gaoge Medical Technology Co., Ltd. in China, it is reasonable to assume the testing was conducted in China or conducted by a laboratory in accordance with international standards. These are prospective tests performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes the performance testing of a physical medical device (a surgical face mask) against established industry standards (e.g., ASTM F2100, ISO 10993). Ground truth in this context is established by the measurement instruments and methodologies defined by these standards, not by expert consensus or interpretation of medical images/data. Therefore, there are no "experts" establishing a ground truth in the way one would for diagnostic AI. The results are objective measurements from laboratory tests.
4. Adjudication method for the test set
Not applicable. As described above, the "ground truth" is determined by objective physical and chemical testing methods according to recognized standards, not by human adjudication of ambiguous cases.
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 submission for a physical medical device (surgical face mask), not an AI/Software as a Medical Device (SaMD) that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a physical medical device (surgical face mask), not an AI/Software as a Medical Device (SaMD).
7. The type of ground truth used
The ground truth used for establishing the device's performance is based on objective measurements from laboratory testing according to recognized industry standards (e.g., ASTM F2100 for performance criteria, ISO 10993 for biocompatibility).
8. The sample size for the training set
Not applicable. This device is a physical surgical face mask, not an AI/Software as a Medical Device (SaMD) that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical surgical face mask, not an AI/Software as a Medical Device (SaMD).
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