(102 days)
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.