Search Results
Found 1 results
510(k) Data Aggregation
(446 days)
The Surgical Face Masks are is 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 Masks are single use, three-layer, flat -folded masks with ear loops and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spunbond 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 PVC wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text describes the acceptance criteria and the study results for the "Surgical Face Mask: F-Y1-A".
1. Table of acceptance criteria and the reported device performance:
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot1: 99.64%, Lot2: 99.70%, Lot3: 99.63% (Pass) |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot1: 99.6%, Lot2: 99.8%, Lot3: 99.4% (Pass) |
| Differential Pressure (Delta P) (MIL-M-36954C) | < 5.0mmH2O/cm² | Lot1: 3.4mmH2O/cm², Lot2: 3.2mmH2O/cm², Lot3: 3.4mmH2O/cm² (Pass) |
| Flammability (16 CFR 1610) | Class 1 | Class 1 (Pass) |
| Irritation (ISO 10993-10) | Under the conditions of the study, the device is non-irritating | Under the conditions of the study, the device is non-irritating (Pass) |
| Sensitization (ISO 10993-10) | Under the conditions of the study, the device is non-sensitizing | Under the conditions of the study, the device is non-sensitizing (Pass) |
| Cytotoxicity (ISO 10993-5) | Under the conditions of the study, the device is non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic (Pass) |
2. Sample size used for the test set and the data provenance:
- Sample Size: For Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability, 3 non-consecutive lots of the device were tested. For Irritation, Sensitization, and Cytotoxicity, the testing refers to "the conditions of the study" without specifying a particular numerical sample size, though these are typically conducted on biological samples.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It is a submission to the FDA from a Chinese manufacturer (Jiande Chaomei Daily Chemicals Co., Ltd. in China), so it is likely that the testing was conducted in China or by a laboratory recognized by the manufacturer. The studies are non-clinical (laboratory-based) and would be considered prospective for the purpose of demonstrating compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies are non-clinical (laboratory performance tests for a surgical face mask) and do not involve expert interpretation or ground truth establishment in the way a diagnostic imaging study would. The acceptance criteria are based on established standards (e.g., ASTM, MIL-M, ISO, CFR).
4. Adjudication method for the test set:
This information is not applicable as the studies are non-clinical performance tests for a surgical face mask, not studies requiring expert adjudication methods. The results are quantitative measurements or assessments 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:
This information is not applicable. The device is a surgical face mask, not an AI-assisted diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical product (surgical face mask), not an algorithm or software requiring standalone performance testing.
7. The type of ground truth used:
The "ground truth" for this device is based on established industry standards and regulatory requirements (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610, ISO 10993-10, ISO 10993-5). The device's performance is measured against the specified thresholds and criteria outlined in these standards.
8. The sample size for the training set:
This information is not applicable. The device is a physical product (surgical face mask) undergoing performance testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated in point 8.
Ask a specific question about this device
Page 1 of 1