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510(k) Data Aggregation
(69 days)
The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile/sterile.
The proposed devices are three-layer, flat pleated masks. It has two design styles, i.e. earloop and tie-on. Each mask is composed of a mask body, a nose piece, two ear loops or four tie tapes. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four tie tapes welded to the mask body. The elastic ear loops are knitted elastic loops (made of nylon and spandex), and the tie tapes are made of polypropylene nonwoven fabric. The nose piece is enclosed between the layers of face mask to allow the user to fit the face mask around their nose, which is an iron wire with polypropylene covering. The proposed devices can simultaneously meet the requirements for the performance class of level 2 and level 3 specified in ASTM F2100. Both of the two design styles are available non-sterile. They are intended to be single use, disposable devices.
The provided document is a 510(k) summary for a Surgical Mask (K222335) and does not describe an AI/ML powered medical device. Therefore, the information typically requested regarding acceptance criteria, study details, and ground truth establishment for such devices (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) will not be present.
Instead, the document details the performance testing of the surgical mask against established standards for medical face masks. The acceptance criteria are based on ASTM F2100-19 for performance and ISO 10993 for biocompatibility.
Here's a summary based on the provided text for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance:
| Test | Purpose | Acceptance Criteria per ASTM F2100-19 (AQL=4.0%) | Reported Device Performance (Sterile earloop mask, 175*95mm) | Reported Device Performance (Non-sterile earloop mask, 175*95mm) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: Pass at 120 mmHg Level 3: Pass at 160 mmHg | 96 out of 96 pass at 120 mmHg 96 out of 96 pass at 160 mmHg | 96 out of 96 pass at 120 mmHg 94 out of 96 pass at 160 mmHg¹ |
| Bacterial filtration efficiency (BFE) (ASTM F2101) | Verify the bacterial filtration efficiency of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: ≥98% Level 3: ≥98% | 99.4%~99.7% (Average: 99.6%) | >99.9% (Average: >99.9%) |
| Particulate filtration efficiency (PFE) (ASTM F2299) | Verify the particulate filtration efficiency of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: ≥98% Level 3: ≥98% | 97.64%~99.11% ² (Average: 98.38%) | 99.88%~>99.9977% (Average: >99.99%) |
| Differential pressure (Delta-P) (EN 14683) | Verify the differential pressure of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: <6.0 mmH₂O/cm² Level 3: <6.0 mmH₂O/cm² | (2.4~3.4) mmH₂O/cm² (Average: 2.7 mmH₂O/cm²) | (4.3~5.9) mmH₂O/cm² (Average: 5.5 mmH₂O/cm²) |
| Flammability (16 CFR 1610) | Verify the flammability of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: Class 1 Level 3: Class 1 | Class 1 | Class 1 |
| In vitro Cytotoxicity (ISO 10993-5) | Verify that the proposed device extract is non-cytotoxic. | The extract is non-cytotoxic under the research conditions. | Pass | Pass |
| Skin Irritation (ISO 10993-10) | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the research conditions. | Pass | Pass |
| Skin Sensitization (ISO 10993-10) | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the research conditions. | Pass | Pass |
Notes:
- ¹ Two samples (one sample per lot in two lots among the three lots) did not meet the acceptance criteria for Fluid Resistance at 160mmHg.
- ² Only one data (97.64%) did not meet the acceptance criteria for Particulate filtration efficiency.
2. Sample size used for the test set and the data provenance:
- For performance tests (Fluid Resistance, BFE, PFE, Differential Pressure, Flammability): Three lots, with 32 samples per lot were used. The provenance is not explicitly stated as country of origin, but the manufacturer is Luoyang Sunmed Devices Co., Ltd. from China. These are prospective tests on manufactured devices.
- For biocompatibility tests (Cytotoxicity, Skin Irritation, Skin Sensitization): The sample size is not explicitly mentioned with numerical values like "32 per lot" as in the performance section, but tests were conducted on the proposed device extract. The provenance is not specified.
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 for this type of device. The "ground truth" for a surgical mask's performance is established by standardized physical and biological testing methods (e.g., fluid penetration, bacterial filtration, flammability), not by expert consensus or interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as the tests are objective laboratory measurements against predefined physical and biological criteria, not subjective interpretations requiring adjudicated consensus.
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 is not applicable as the device is a surgical mask and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a surgical mask and not an algorithm.
7. The type of ground truth used:
The ground truth is based on standardized test methods and predetermined performance thresholds as defined by standards such as ASTM F2100-19 and ISO 10993 series for medical device performance and biocompatibility.
8. The sample size for the training set:
This is not applicable as the device is a surgical mask and not an AI/ML model that undergoes training.
9. How the ground truth for the training set was established:
This is not applicable as the device is a surgical mask and not an AI/ML model for which a training set and its ground truth would be established.
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