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510(k) Data Aggregation
(60 days)
The Medical Face Mask is 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 a single use, disposable device(s), provided non-sterile.
The proposed device(s) 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 Nylon and polyester. 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 polyethylene coated galvanized wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
This document pertains to the 510(k) premarket notification for a Medical Face Mask, and as such, it describes performance testing for a physical medical device, not software or an AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI/algorithm performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable.
However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate it meets those criteria.
Acceptance Criteria and Device Performance for Ammex-Weida (Hubei) Health and Safety Products Co., Ltd's Medical Face Mask
The device under review is a Medical Face Mask, a physical device, not an AI/algorithm-based one. The acceptance criteria are based on established performance standards for medical face masks.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Medical Face Mask (Proposed Device, K211062)
Classification: Class II, ASTM F2100 Level 3 (meets Level 3 requirements)
| Performance Characteristic | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 Pass at 160 mmHg | 32 out of 32 Pass at 160 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 98.98% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.9% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH₂O/cm² | 5.54 mmH₂O/cm² | PASS |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | PASS |
Biocompatibility Testing (ISO 10993)
| Biocompatibility Test | Acceptance Criteria | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|
| 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 Used for the Test Set and Data Provenance
- Sample Sizes: The document specifies sample sizes for some tests:
- Fluid Resistance (ASTM F1862): 32 samples were tested ("32 out of 32 Pass").
- For other tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, and Biocompatibility, specific sample sizes are not explicitly stated in this summary, but these are standardized tests that follow defined sample size protocols for regulatory compliance.
- Data Provenance: The tests were non-clinical and conducted to verify design specifications and similarity to the predicate device. The tests were performed according to specified standards (e.g., ASTM, EN, ISO, CFR). The country of origin for the manufacturing company is China (Hubei, China), and the submission correspondent is based in Shanghai, China. The document does not specify whether the data collection for these performance tests was retrospective or prospective, though performance testing for device clearance is typically prospective by nature.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a physical device, not an AI/algorithm requiring expert-established ground truth for diagnostic accuracy. Performance is measured against physical and biological properties.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a physical device, there is no "ground truth" established by human experts that requires adjudication in the context of diagnostic accuracy. The testing involves standardized laboratory methods with objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This type of study is relevant for diagnostic imaging or AI algorithms where human interpretation is involved. This device is a medical face mask, and its effectiveness is determined by objective physical and biological barrier tests, not human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
- Objective Measurement against Standards: The "ground truth" for this device's performance is established by objective laboratory measurements against predefined international and national standards (ASTM, EN, ISO, CFR). For example:
- Fluid Resistance: Measured by the device's ability to resist penetration by synthetic blood at a certain pressure.
- Filtration Efficiency: Measured by the percentage of particles or bacteria filtered out.
- Differential Pressure: Measured by the breathability of the material.
- Flammability: Measured by how easily the material ignites and burns.
- Biocompatibility: Measured by the material's non-toxicity, non-irritating, and non-sensitizing properties in biological tests.
8. Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of machine learning. The manufacturing process and material selection are based on established engineering and materials science principles and validated through the non-clinical tests described.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/algorithm, there is no corresponding "ground truth establishment."
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