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510(k) Data Aggregation
(120 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. They 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 Surgical Face Masks are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has nose clips design for fitting the face mask around the nose. The proposed device(s) are 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 users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene (PP) and iron wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
Acceptance Criteria and Device Performance for Surgical Face Mask (K212574)
The provided document describes the acceptance criteria and the results of non-clinical tests performed on the "Surgical Face Mask" (model DM-FM) submitted by Xiantao Deming Healthcare products Co., Ltd. for 510(k) clearance (K212574).
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria: ASTM F2100 Level 2 | Reported Device Performance (K212574) | Result |
|---|---|---|---|
| Fluid Resistance | 29 out of 32 pass at 120 mmHg for Level 2 | 32 out of 32 pass at 120 mmHg, 3 lots | PASS |
| Particulate Filtration Efficiency | ≥ 98% | Min=98.38%; 98.03%; 98.90% (across 3 lots, implied from context) | PASS |
| Bacterial Filtration Efficiency | ≥ 98% | Min=99.43%; 99.74%; 99.74% (across 3 lots, implied from context) | PASS |
| Differential Pressure | < 6.0 mmH2O/cm² | Max=3.1 mm H2O/cm²; 3.0 mm H2O cm²; 3.1 mm H2O cm² (across 3 lots, implied) | PASS |
| Flammability | Class 1 | Class 1 | PASS |
| Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Irritation | Non-irritating | Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization | Non-sensitizing | Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Non-clinical tests were conducted using 3 nonconsecutive lots of the surgical face mask. The specific number of masks tested per lot for each parameter is not explicitly stated in the summary, however, for fluid resistance it states "32 out of 32", which indicates a sample size of 32 masks were tested for that specific parameter.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that it is a submission for device clearance, it is highly likely that the testing was conducted prospectively according to established standards.
3. Number of Experts and Qualifications for Ground Truth
- This document describes non-clinical performance testing of a physical medical device (surgical face mask) based on established international and national standards (e.g., ASTM F2100, ISO 10993). Therefore, no human experts were used to establish ground truth in the way they would be for an AI/ML-based diagnostic device. The "ground truth" here is determined by the objective measurements obtained through standardized laboratory test methods.
4. Adjudication Method
- As this section pertains to non-clinical laboratory testing of a physical device against objective standards, no adjudication method (like 2+1 or 3+1 consensus) was used. The test results are quantitative measurements against predefined thresholds.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This is a submission for a physical medical device (surgical face mask) and not an AI/ML diagnostic or assistive technology. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
6. Standalone Performance Study
- A standalone performance study was done regarding the device's physical properties and biocompatibility. The results for each specific test (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Cytotoxicity, Irritation, and Sensitization) represent the standalone performance of the surgical face mask itself, independent of any human user interaction beyond typical mask wear.
7. Type of Ground Truth Used
- The ground truth used for this device is based on objective, standardized laboratory measurements and test methods. These methods are specified by recognized standards such as ASTM F2100, ASTM F1862, EN 14683, ASTM F2101, ASTM F2299, 16 CFR 1610, ISO 10993-5, and ISO 10993-10. The acceptance criteria represent the predefined thresholds or performance levels mandated by these standards for a Level 2 surgical face mask.
8. Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device and does not involve an AI/ML algorithm or a training set in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As no AI/ML algorithm or training set was used, the concept of establishing ground truth for a training set is not relevant to this device submission.
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