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.

Device Description

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.

AI/ML Overview

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.

Summary

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SEP 1 6 2011

AI I for K111559 Surgical Masks

Exhibit #1 510(k) Summary

Exhibit # 1 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

1. Date of Submission: May 20, 2011
1. Sponsor

Shanghai Neo-Medical Import & Export Co.,Ltd Room 1503, No.2368, ZhongShanxi Road, Shanghai, 200030, China Establishment Registration Number: 3005327291 Contact Person: Pei Zhang Position: General Manager Tel: +86-21-54652962 Fax: +86-21-64673414 Email: Peter999@neo-medical.net

3. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

1. Proposed Device Identification Proposed Device Name: Surgical Masks Proposed Model: NM-MA-008, NM-MA-010, NM-MA-011 and NM-MA-018 Classification: II Product Code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: General & Plastic Surgery .
  Intended Use Statement:

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1. Predicate Device Identification 510(k) Number: K061864 Product Name: Non Sterile Surgical Mask Manufacturer: Dukal Corporation
1. Device Description

ProductModel:	Model Description
	Mask	Ear loop	Tie on	Shield
NM-MA-010	X	X
NM-MA-011	X		X
NM-MA-008	X		X	X
NM-MA-018	X	X		X

Table III-1 Surgical Masks Description

All of the proposed devices are non-sterile, and only for single use.

1. Non-Clinical Test Conclusion
  Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies: with the following standards:
ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face a. Masks.
ف Fluid Resistance per 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)

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Bacterial Filtration Efficiency (BFE) Test per EN 14683: 2005 Surgical masks, Requirements and ن test methods.
Particulate Filtration Efficiency (Latex Particle Challenge) Test per ASTM F 2299-03 Standard Test di Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
Flammability , per 16 CFR 1610, Standard for the Flammability of Clothing Textiles; Corrections e.
Differential Pressure (Delta-P) Test per Mil M36954C Military Specification- Mask, Surgical, f. Disposable
Biocompatibility :Cytotoxicity, Sensitization, Irritation g.
- Including: 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"
1. Substantially Equivalent Conclusion

The proposed devices are determined to be Substantially Equivalent (SE) to the predicate device, Non Sterile Surgical Mask (K061864) in respect of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 1 6 2011

Shanghai Neo Medical Import & Export Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 237-023 Shanghai China 200237

Re: K111559

Trade/Device Name: Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: August 9, 2011 Received: August 26, 2011

Dear Ms. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Hong

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hn fo

Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit #3 IFU Statement

510(k) Number: K111559 Device Name: Surgical Masks Models: NM-MA-008, NM-MA-010, NM-MA-011, NM-MA-018

Indications for Use:

□PRESCRIPTION USE (Part 21 CFR 801 Subpart D) ZOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Elliott F. Currie W.K.

(ISON 2008) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111559

Regulation Number and Section

§ 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.