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510(k) Data Aggregation
(105 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, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch. The Surgical Face Masks 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron bar coated with Polyolefin. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices. The proposed device will be provided in two models of level 3. The two models are totally the same, only distinguished by level 2 & level 3 for business purpose.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the "Surgical Face Mask":
Device Name: Surgical Face Mask (Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD)
Regulatory Class: Class II
Product Code: FXX
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 2 & 3) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance | Evaluate resistance to penetration by synthetic blood (Minimum pressure in mmHg) | Level 2: 29 out of 32 pass at 120 mmHgLevel 3: 29 out of 32 pass at 160 mmHg | PASS: 32 out of 32 pass at 160 mmHg (for both Level 2 & 3 models) |
| Particulate Filtration Efficiency (PFE) | Evaluate sub-micron particulate filtration efficiency at 0.1 micron (%) | ≥ 98% | PASS: 98.7%; 98.72%; 99.28% |
| Bacterial Filtration Efficiency (BFE) | Evaluate bacterial filtration efficiency (%) | ≥ 98% | PASS: 99.88%; 99.89%; 99.83% |
| Differential Pressure (Delta-P) | Evaluate breathability/resistance to airflow | < 6.0 mmH2O/cm² | PASS: 3.94 mmH2O/cm²; 4.01 mmH2O/cm²; 3.55 mmH2O/cm² |
| Flammability | Evaluate flame spread | Class 1 | PASS: Class 1 |
| Cytotoxicity | Demonstrate biocompatibility safety (in vitro cytotoxicity) | Non-cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. |
| Irritation | Demonstrate biocompatibility safety (irritation) | Non-irritating | PASS: Under the conditions of the study, the device is non-irritating. |
| Sensitization | Demonstrate biocompatibility safety (skin sensitization) | Non-sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Non-clinical tests were conducted using 3 nonconsecutive lots with 32 samples for each model of surgical mask (Total samples = 3 lots * 32 samples/lot = 96 samples per model). The summary mentions two models (Level 2 & Level 3). So, potentially 192 samples in total for the testing described.
- Data Provenance: The document does not explicitly state the country of origin of the test data (i.e., where the tests were performed). The manufacturer is in Hubei Province, China. The studies are retrospective in the sense that they are conducted on finished product samples to verify design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable: For this type of medical device (surgical face mask), the ground truth for performance is established through objective laboratory testing against recognized international and national standards (e.g., ASTM, ISO, EN, CFR), not through expert consensus or interpretation. The tests are quantitative and have predefined pass/fail criteria.
4. Adjudication Method for the Test Set
- Not Applicable: Since the tests are objective laboratory measurements, there is no human adjudication process involved in determining the test results. The results are based on direct measurement and comparison to predefined numerical criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is being evaluated. Surgical masks do not involve human interpretation in their use or performance evaluation in this context.
6. Standalone Performance Study
- Yes, a standalone study was done. The entire "Summary of Non-Clinical Test" section (G) describes the standalone performance of the device against various ASTM, ISO, EN, and CFR standards. This evaluation is of the device itself (algorithm only, in AI terms) without human interaction being part of the performance measurement.
7. Type of Ground Truth Used
- The ground truth used for these tests is based on established standard specifications and methodologies defined by organizations such as ASTM, ISO, EN, and CFR. These standards define the acceptable performance thresholds and testing procedures for surgical face masks. It's essentially a normative ground truth derived from regulatory and industry consensus on what constitutes a safe and effective surgical face mask.
8. Sample Size for the Training Set
- Not Applicable: This device is a physical product (surgical face mask) and does not involve an AI algorithm or machine learning model that requires a "training set" in the computational sense. The product's design and manufacturing processes are validated, but there isn't a data-driven training phase like in AI.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As stated above, there is no "training set" for this device. The manufacturing processes and material specifications are developed based on engineering principles and compliance with the relevant standards.
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