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510(k) Data Aggregation
(102 days)
SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.
The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.
The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.
The proposed devices are available in four models with same mask (3-ply) and different configurations, such as ear loop, tie on, eye shield and foam. Detail configurations of them are presented in Table V-1 Surgical Masks Description.
All of the proposed devices are non-sterile, and only for single use.
This medical device is a surgical mask and the "study" referred to is a series of bench tests to demonstrate compliance with various standards, not a clinical study involving human participants or AI. Therefore, most of the requested information (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, AI improvement effect size, standalone performance, ground truth types) is not applicable in this context.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by various standards for mask performance. The reported device performance is that the proposed device complies with these standards.
| Performance Metric | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Performance | ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face Masks | Complies |
| Fluid Resistance | ASTM F 1862-07 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) | Complies |
| Bacterial Filtration Efficiency (BFE) | EN 14683: 2005 Surgical masks, Requirements and test methods. | Complies |
| Particulate Filtration Efficiency (PFE) | ASTM F 2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | Complies |
| Flammability | 16 CFR 1610, Standard for the Flammability of Clothing Textiles; Corrections | Complies |
| Differential Pressure (Delta-P) | Mil M36954C Military Specification- Mask, Surgical, Disposable | Complies |
| Biocompatibility | - ISO 10993-5:2009 "Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity." |
- ISO 10993-10:2002 Standard, "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity"
- ISO 10993-10:2002 Standard and Amendment 1, 2006. "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT I" | Complies |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the conventional sense for a clinical study. Instead, these are bench tests conducted to verify the device met design specifications. The data provenance is not explicitly stated as retrospective or prospective, but as bench tests, they are inherently prospective in their execution for the purpose of the 510(k) submission. The country of origin for the testing itself is not stated, but the manufacturer is based in Shanghai, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these types of engineering and performance tests is defined by the objective measurement criteria within the specified standards, not by expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is used for these objective performance 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
Not applicable. This is a surgical mask, not an AI-powered diagnostic device. No human-in-the-loop performance or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device (surgical mask), not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for these tests is defined by the objective physical and chemical properties and performance characteristics as measured against the specifications outlined in the referenced ASTM, EN, 16 CFR, Mil M, and ISO standards.
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment.
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