Search Results
Found 1 results
510(k) Data Aggregation
(97 days)
The disposable medical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks 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 proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of spunbond polypropylene nonwoven fabric, and the middle layer is made of meltblown polypropylene nonwoven fabric. The model of proposed device, ear-loop, is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of spandex and nylon, not made from natural rubber latex. The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is a iron wire with polypropylene covering. The proposed device is provided non-sterile and is intended to be a single use, disposable device.
The provided document describes the performance testing and acceptance criteria for a "Disposable Medical Mask" (K210018).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (per ASTM F2100-19 Level 3) | Reported Device Performance (ASTM F2100-19 Level 3) | Average Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Pass at 160 mmHg | Pass at 160 mmHg (96/96) | N/A |
| Bacterial filtration efficiency (BFE) (ASTM F2101) | ≥ 98% | Pass (96/96) | 99.9% |
| Particulate filtration efficiency (PFE) (ASTM F2299) | ≥ 98% | Pass (96/96) | 99.8% |
| Differential pressure (Delta-P) (EN 14683) | < 6.0 mmH2O/cm² | Pass (96/96) | 4.5 mmH2O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Pass (96/96) | N/A |
| Biocompatibility (ISO 10993-5 and ISO 10993-10) | Device is non-cytotoxic, non-irritating, non-sensitizing | Device is non-cytotoxic, non-irritating, non-sensitizing | N/A |
2. Sample size used for the test set and the data provenance
- Sample Size for Bench Testing: For each performance test (Fluid Resistance, BFE, PFE, Differential Pressure, Flammability), the test set consisted of 96 samples. These samples were composed of "32 Samples each from 3 non-consecutive lots."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given that it's a premarket notification for a device manufactured in China, it's highly probable the testing was conducted by or on behalf of the manufacturer in China, prospectively for this submission.
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 document describes performance testing for a medical mask, which involves objective laboratory measurements against established standards (e.g., ASTM F2100-19, EN 14683, ISO 10993). Expert consensus or human interpretation is not used to establish "ground truth" for these types of physical and biological performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters where there might be subjective assessments requiring conflict resolution. The tests described are objective, quantitative laboratory tests.
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 disposable medical mask, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant.
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 medical mask, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the performance tests is based on established quantitative standards and methodologies defined by organizations like ASTM, EN, and ISO. For example:
- Fluid Resistance: Defined by ASTM F1862.
- Bacterial Filtration Efficiency: Defined by ASTM F2101.
- Particulate Filtration Efficiency: Defined by ASTM F2299.
- Differential Pressure: Defined by EN 14683.
- Flammability: Defined by 16 CFR 1610.
- Biocompatibility: Defined by ISO 10993-5 and ISO 10993-10.
8. The sample size for the training set
This information is not applicable. There is no "training set" for a physical medical mask's performance testing. Training sets are relevant for machine learning or AI models.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
Ask a specific question about this device
Page 1 of 1