MEO Med Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.

Device Description

The MEO Med Disposable Medical Face Mask is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of HDPE (high density polyethylene). The MEO Med Disposable Medical Face Mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, specifically a disposable medical face mask. It outlines the device's characteristics, intended use, and performance testing results to demonstrate substantial equivalence to a legally marketed predicate device.

It's important to note that the document does not describe a study involving an AI/algorithmic device where the terms like "AI assistance," "human readers," "ground truth," "training set," or "multi-reader multi-case (MRMC) study" would be relevant. The device in question is a physical product (a face mask), and the criteria listed pertain to its physical and functional performance, not the accuracy or effectiveness of an AI algorithm.

Therefore, I cannot provide information on the following points from your request, as they are not applicable to the provided document:

Sample sized used for the test set and the data provenance (no data set in the AI sense)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (no ground truth in the AI sense)
Adjudication method (not applicable)
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 to a face mask)
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (not applicable to a face mask)
The type of ground truth used (expert consensus, pathology, outcomes data, etc) (not applicable to a face mask)
The sample size for the training set (not applicable to a face mask)
How the ground truth for the training set was established (not applicable to a face mask)

However, I can extract and present the acceptance criteria for the physical face mask and its reported performance based on the provided document:

Acceptance Criteria and Reported Device Performance for MEO Med Disposable Medical Face Mask (K210870)

The study conducted for this device is a series of non-clinical performance tests designed to evaluate the physical and functional properties of the face mask, aligning with the standards for a medical face mask (ASTM F2100-19 Level 2). There was no AI component or clinical study involving human readers or large datasets in the context of an algorithm's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria (ASTM F2100-19 Level 2)	Reported Device Performance (Results)
Bacterial Filtration Efficiency (BFE) (%)	To measure the bacterial filtration efficiency (BFE) of medical face mask materials	≥98	Lot 1: 99.1%-99.9% (Passed) Lot 2: 99.0%-99.9% (Passed) Lot 3: 99.1%-99.9% (Passed)
Differential Pressure (mmH2O/cm²)	To determine the breathability of medical face mask	<6.0 mmH2O/cm²	Lot 1: 3.9-4.9 mmH2O/cm² (Passed) Lot 2: 4.0-4.9 mmH2O/cm² (Passed) Lot 3: 3.8-4.8 mmH2O/cm² (Passed)
Sub-micron Particulate Filtration Efficiency at 0.1 micron, % (PFE)	To measure the initial filtration efficiency of materials used in medical face masks	≥98	Lot 1: 99.29%-99.64% (Passed) Lot 2: 99.31%-99.66% (Passed) Lot 3: 99.28%-99.68% (Passed)
Resistance to Penetration by Synthetic Blood, Minimum pressure in mmHg for pass result	To evaluate the resistance of medical face mask to synthetic blood penetration	29 of 32 test articles passed at 120mmHg	Lot 1: 309/315 passed Lot 2: 308/315 passed Lot 3: 308/315 passed
Flame Spread	To measure the response of materials, products or assemblies to heat and flame	Class 1	Lot 1: 315/315 passed Lot 2: 315/315 passed Lot 3: 315/315 passed

Additionally, bioreactivity tests were conducted:

Cytotoxicity: Under the conditions of the study, the device is noncytotoxic. (Passed)
Irritation: Under the conditions of the study, the device is nonirritating. (Passed)
Sensitization: Under the conditions of the study, the device is nonsensitizing. (Passed)

2. Sample Size Used for the Test Set and Data Provenance
The sample sizes are indicated as the number of items tested for each specific criterion (e.g., "315/315 passed" for flame spread, or "309/315 passed" for synthetic blood penetration across three lots). The data provenance is implied to be from laboratory testing conducted on manufactured lots of the product. The manufacturer is Fujian MEO Medical Technology Limited, located in China. The study is a pre-market notification (510(k)) submission, meaning it is a prospective evaluation (tests are conducted specifically for the submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for a face mask's performance is established by standardized, objective laboratory testing methodologies (e.g., ASTM F2100-19) that measure physical properties, not by human expert interpretation of data.

4. Adjudication Method for the Test Set
Not applicable. Performance is measured objectively according to specified test 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
Not applicable. This is a physical device, not an AI algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an AI algorithm.

7. The Type of Ground Truth Used
The ground truth used for this device is based on standardized laboratory testing protocols (e.g., those outlined in ASTM F2100-19) for measuring specific physical and performance characteristics of medical face masks (e.g., filtration efficiency, breathability, fluid resistance, flammability, and biocompatibility).

8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm that requires a training set. The "training" for such a product would typically refer to the manufacturing process and quality control, not data training.

9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a physical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 30, 2021

Fujian MEO Medical Technology Limited % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K210870

Trade/Device Name: MEO Med Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX. Dated: June 16, 2021 Received: June 23, 2021

Dear Boyle Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210870

Device Name MEO Med Disposable Medical Face Mask

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K210870

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

1.0 Submitter's information

Name: Fujian MEO Medical Technology Ltd. Address: Floor 4th, No. 1 Production Building, No. 36 Guabao Road, Dongqiao Business Development Zone, Ningde City, Fujian, 352100, CHINA Phone Number: +86-13599192517 Contact: Ms. Zhuang Yan Date of Preparation: 16/03/2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device information

Trade name: MEO Med Disposable Medical Face Mask Common name: MEO Med Disposable Medical Face Mask Classification name: Mask, Surgical Model(s): ear strap, 175×95mm

3.0 Classification

Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel

4.0 Predicate device information

Manufacturer: Wuhan Dymex Healthcare Co., Ltd Device: Surgical Face Mask 510(k) number: K182515

5.0 Indication for Use Statement

MEO Med Disposable Medical Face Mask is intended to be worn to protect both the

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patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.

6.0 Device description

Table 1 - General Comparison
Item	Proposed device	Predicated device	Remark
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Product name	MEO Med DisposableMedical Face Mask	Surgical Face Mask	-
510(k) No.	K210870	K182515	-
Models	ear strap, 175×95mm	ear strap	-
Intended Use	The MEO Med DisposableMedical Face Mask isintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. It is intended for usein infection control practicesto reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non sterile.	The Surgical Face Masksare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile.	Same
OTC use	Yes	Yes	Same
Composite	Flat Pleated, 3 layers	Flat Pleated, 3 layers	Same

7.0 Technological Characteristic Comnarison Table

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Internal layer	Spun-bond polypropylene	Spun-bond polypropylene	Same
Middle layer	Melt blown polypropylene	Melt blown polypropylene	Same
External layer	Spun-bond polypropylene	Spun-bond polypropylene	Same
Nose piece	High Density Polyethylene	Malleable polyethylenewire	* Gap 1
ear strap	Polyester, spandex	spandex	* Gap 2
Color	Blue	Yellow	* Gap 3
Dimension (Length)	17.5cm±0.5cm	17.5cm±0.2cm	* Gap 4
Dimension (Width)	9.5cm±0.5cm	9.5cm±0.2cm	* Gap 5
Sterility	Non-Sterile	Non-Sterile	Same
	Single Use	Yes	Same
	Sterile	No	Same
	ASTM F2100 Level	Level 2	Same

Gap analysis:

Gap 1-3: the two devices have some difference in materials and product colors, product materials safety is proved by its biocompatibility.

Gap 4-5: the two devices share same dimensions.

8.0 Non-Clinical Test Conclusion

The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: MEO Med Disposable Medical Face Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.

Table 2 - Performance Testing

Test Methodology	Purpose	Acceptance Criteria(Level 2,ASTMF2100-19)	Result
Bacterial filtrationefficiency (BFE) (%)	To measure thebacterial filtrationefficiency (BFE) ofmedical face maskmaterials	≥98	Lot 1: 99.1%-99.9%passedLot 2: 99.0%-99.9%passedLot 3: 99.1%-99.9%passedPass
Different pressure(mmH2O/cm²)	To determine thebreathability ofmedical face mask	<6.0 mmH2O/cm²	Lot 1: 3.9-4.9mmH2O/cm²PassedLot 2: 4.0-4.9mmH2O/cm²Passed

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			Lot 3: 3.8-4.8mmH2O/cm²Passed
			Pass
Sub-micronparticulate filtrationefficiency at 0.1micron, % (PFE)	To measure theinitial filtrationefficiency ofmaterials used inmedical face masks	≥98	Lot 1:99.29%-99.64%PassedLot 2: 99.31%-99.66%passedLot 3: 99.28%-99.68%passedPass
Resistance topenetration bysynthetic blood,Minimum pressureinmmHg for pass result	To evaluatethe resistanceof medicalface mask tosyntheticbloodpenetration	29 of 32 testarticles passed at120mmHg	Lot 1: 309/315 passedLot 2: 308/315 passedLot 3: 308/315 passedPass
Flame spread	To measure theresponse ofmaterials, productsor assemblies toheat and flame.	Class 1	Lot 1: 315/315 passedLot 2: 315/315 passedLot 3: 315/315 passedPass

Table 2 - Biocompatibility Testing

Item	Proposed Device	Result
Cytotoxicity	Under the conditions of the study, the device is noncytotoxic.	Pass
Irritation	Under the conditions of the study, the device is nonirritating.	Pass
Sensitization	Under the conditions of the study, the device is nonsensitizing.	Pass

No clinical study implemented for the MEO Med Disposable Medical Face Mask.

8.0_Clinical Test Conclusion

10.0 Conclusion

The conclusions drawn from the non-clinical test demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device.

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.