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510(k) Data Aggregation
(428 days)
The disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.
The document describes the testing and acceptance criteria for a "Disposable Surgical Face Mask" (K212649). This is a medical device, not an AI/ML device, therefore, many of the requested categories such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set" are not applicable.
Here's the information extracted and organized as requested, with "N/A" for sections not relevant to a non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| No | Item | Test Method/Standard | Type | Acceptance Criteria | Reported Performance for Ear Loop Type | Reported Performance for Tie-on Type |
|---|---|---|---|---|---|---|
| 1 | Particulates Filtration Efficiency | ASTM F2299/F2299M-03(2017) | Ear loop | ≥98% | Lot 1: 98.81%Lot 2: 98.78%Lot 3: 98.8% | N/A (listed separately below) |
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 98.82%Lot 2: 98.78%Lot 3: 98.79% | |||
| 2 | Bacterial Filtration Efficiency | ASTM F2101-19 | Ear loop | ≥98% | Lot 1: 99.9%Lot 2: 99.91%Lot 3: 99.91% | N/A (listed separately below) |
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 99.91%Lot 2: 99.9%Lot 3: 99.91% | |||
| 3 | Fluid Resistance | ASTM F1862/F1826M-17 | Ear loop | 120 mmHg | Lot 1: No penetration at 120 mmHgLot 2: No penetration at 120 mmHgLot 3: No penetration at 120 mmHg | N/A (listed separately below) |
| Tie-on | 120 mmHg | N/A (listed above) | Lot 1: No penetration at 120 mmHgLot 2: No penetration at 120 mmHgLot 3: No penetration at 120 mmHg | |||
| 4 | Differential Pressure | EN 14683:2019 | Ear loop | △P<6.0 mm H2O/cm2 | Lot 1: 3.59Lot 2: 3.59Lot 3: 3.59 | N/A (listed separately below) |
| Tie-on | △P<6.0 mm H2O/cm2 | N/A (listed above) | Lot 1: 3.61Lot 2: 3.59Lot 3: 3.61 | |||
| 5 | Flammability | ASTM F2100-19 | Ear loop | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 | N/A (listed separately below) |
| Tie-on | Class 1 | N/A (listed above) | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 |
Biocompatibility Tests:
| No | Item | Test Method/Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass (No potential toxicity) |
| 2 | Irritation | ISO 10993-10 | Non-irritating | Pass (No Irritation) |
| 3 | Skin Sensitization | ISO 10993-10 | Non-sensitizing | Pass (No Sensitization) |
2. Sample Size Used for the Test Set and the Data Provenance
For all performance tests (Particulates Filtration Efficiency, Bacterial Filtration Efficiency, Fluid Resistance, Differential Pressure, Flammability):
- Sample Size: 3 non-consecutive lots were tested for each type (Ear loop and Tie-on). For each lot, a sample size of 125 was used.
- Data Provenance: Not explicitly stated as country of origin, but the submission is from Lyncmed Medical Technology (Beijing) Co., Ltd. in China, implying testing was likely conducted in or for the company's region. The tests are described as "Non-Clinical Test Conclusion," meaning they were laboratory tests, not clinical studies involving human patients. The report does not specify if the provenance is retrospective or prospective for the samples used for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- N/A. This is a physical medical device, and the acceptance criteria are based on standardized performance tests (e.g., ASTM, EN, ISO standards), not on human expert interpretation of data or images.
4. Adjudication Method for the Test Set
- N/A. As above, the acceptance criteria are based on objective physical and material performance standards.
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
- N/A. This is a physical medical device, not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This is a physical medical device. No algorithm is involved.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance is defined by the objective measurement criteria and threshold values specified in various international and national standards (e.g., ASTM F2299, ASTM F2101, ASTM F1862, EN 14683, ASTM F2100 for performance and ISO 10993 for biocompatibility). These standards set the quantitative benchmarks that the device must meet.
8. The Sample Size for the Training Set
- N/A. This is a physical medical device, not an AI/ML device. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
- N/A. This is a physical medical device. There is no "training set" and therefore no ground truth establishment for it.
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