The Disposable Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are 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 Disposable Medical Surgical Masks are green color, three-layer, flat-folded masks with nose piece and ear loops. The green colorant is polypropylene (PP) master batch.

The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are not made with natural rubber latex or fiberglass, but nylon and spandex.

The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of Iron core coated with Polyethylene.

The Disposable Medical Surgical Masks are sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a Disposable Medical Surgical Mask. It details the device's technical specifications, intended use, and comparison to a predicate device, as well as the results of non-clinical performance and biological safety tests.

However, the request asks for specific information related to acceptance criteria and a study proving a medical device meets these criteria, particularly focusing on aspects like AI assistance, human reader performance improvement, ground truth establishment, sample sizes for training and test sets, and expert involvement. The document describes a surgical mask, which is a physical product, not a medical device that would involve AI, image analysis, or human reader performance in the context of the questions asked.

Therefore, many of the questions asked (e.g., about AI, human readers, ground truth for training/test sets, MRMC studies) are not applicable to the information provided in this document, which pertains to the physical and biological performance of a surgical mask.

I will interpret the request as asking about the acceptance criteria and proof of performance as presented in this document for a surgical mask, acknowledging that many of the AI/image analysis specific questions are not relevant here.

Here's an analysis based on the provided document:

Acceptance Criteria and Study Proving Device Meets Criteria (for a Disposable Medical Surgical Mask)

The study described in this document is a non-clinical performance and biological safety evaluation conducted to demonstrate substantial equivalence of the Disposable Medical Surgical Mask to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Fluid Resistance (ASTM F1862)	To demonstrate the functionality of the subject device.	29 out of 32 pass at 160 mmHg for Level 3	31 out of 32 pass at 160 mmHg, 3 lots; PASS
Particulate Filtration Efficiency (ASTM F2299)	To demonstrate the functionality of the subject device.	≥ 98%	98.8%; 98.8%; 98.8%; PASS
Bacterial Filtration Efficiency (ASTM F2101)	To demonstrate the functionality of the subject device.	≥ 98%	99.8%; 99.8%; 99.8%; PASS
Differential Pressure (Delta P) (EN 14683 Annex C)	To demonstrate the functionality of the subject device.	< 6.0mmH2O/cm²	2.73mm H2O cm²; 2.73mm H2O cm²; 2.73mm H2O cm²; PASS
Flammability (16 CFR 1610)	To demonstrate the functionality of the subject device.	Class 1	Class 1; PASS
Cytotoxicity (ISO 10993-5)	To demonstrate the safety of the subject device.	Non-cytotoxic	Under the conditions of the study, the device is non-cytotoxic.
Irritation (ISO 10993-10)	To demonstrate the safety of the subject device.	Non-irritating	Under the conditions of the study, the device is non-irritating.
Sensitization (ISO 10993-10)	To demonstrate the safety of the subject device.	Non-sensitizing	Under the conditions of the study, the device is non-sensitizing.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document indicates that for the Fluid Resistance test, "32" samples were tested (implied per lot, across 3 lots). For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure, results are presented for "3 lots" (e.g., 98.8%; 98.8%; 98.8%), suggesting samples were drawn from these lots for testing. Specific sample numbers per test within each lot are not explicitly detailed beyond the fluid resistance test.
Data Provenance: The tests were conducted by Suzhou JaneE Medical Technology Co., Ltd. (China) or subcontracted labs. The document does not specify the country of origin of the data in terms of patient data, as this is a non-clinical product. The data provenance is from laboratory testing performed on the manufactured product. It is a prospective test in the sense that the manufacturer conducted these tests specifically for this 510(k) submission on samples of their manufactured device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a surgical mask, and the "ground truth" is established by direct physical and biological testing of the product's material properties and performance against established international standards (ASTM, ISO, EN, CFR) rather than expert interpretation of medical images or patient outcomes. The acceptance criteria are objective laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable. This refers to methods for consolidating expert opinions (e.g., in reading medical images). For physical and biological tests of a surgical mask, the results are typically quantitative measurements or pass/fail determinations based on predefined criteria, not subject to subjective adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical data (e.g., radiologists reading scans). This document describes the testing of a physical product (surgical mask). Therefore, no MRMC study was performed or is relevant to this device.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No. This question applies to AI/software as a medical device (SaMD). The device is a surgical mask, which does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" here is based on objective, quantitative laboratory measurements against established national and international standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, ISO 10993 parts, 16 CFR 1610) that define the performance characteristics of surgical masks. These standards themselves are developed through expert consensus and empirical data regarding the physiological and protective functions of such devices.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a physical medical device like a surgical mask. This term refers to data used to train machine learning models.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a surgical mask, this question is irrelevant.

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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

November 9, 2021

Suzhou JaneE Medical Technology Co., Ltd. Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K212526

Trade/Device Name: Disposable Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 11, 2021 Received: August 11, 2021

Dear Ivy 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 mediation-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,

For 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) K212526

Device Name Disposable Medical Surgical 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

A. Applicant

Suzhou JaneE Medical Technology Co., Ltd. Address: No.339 HuaFeng Road, New District,Suzhou,Jiangsu Province, China, 215129 Contact:Mr.Zhu Li Title: Registration Specialist Tel: +86 13951116714 Email: czhuli@sz-dk.cn

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com

Device: Trade Name: Disposable Medical Surgical Mask Common Name: SURGICAL FACE MASK Model: Rectangle-earloop

Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel

B. Predicate device

K203426 Surgical Face Mask(Non-sterile) Nantong Taiweishi Medical Technology Co., Ltd.

C. Indications for use

The Disposable Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are 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.

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D. Device Description

The Disposable Medical Surgical Masks are green color, three-layer, flat-folded masks with nose piece and ear loops. The green colorant is polypropylene (PP) master batch.

The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are not made with natural rubber latex or fiberglass, but nylon and spandex.

The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of Iron core coated with Polyethylene.

The Disposable Medical Surgical Masks are sold non-sterile and are intended to be single use, disposable devices.

E. Comparison with predicate device

Device		Proposed Device	Predicate Device	Comparison
	Manufacturer	Suzhou JaneE Medical TechnologyCo., Ltd.	Nantong Taiweishi Medical TechnologyCo., Ltd.	-
	510K number	K212526	K203426	-
	Model name	Disposable Medical Surgical MaskModel: Rectangle-earloop	Surgical Face Mask(Non-sterile)	Same
	Classification	Class II Device, FXX (21CFR878.4040)	Class II Device, FXX (21 CFR878.4040)	Same
	Intended use	The Disposable Medical SurgicalMasks are intended to be worn toprotect both the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material.They are intendedfor use in infection control practices toreduce the potential exposure to bloodand body fluids. This is a single use,disposable device(s), provided non-sterile.	The Surgical Face Mask( non-sterile ) is intended to be worn toprotect both the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These face masksare intended for use in infection controlpractices to reduce the potential exposureto blood and body fluids. This a singleuse, disposable device(s), provided non-sterile.	Same
	Design Features	Ear loop, Flat pleats,3 layers	Ear loop, Tie-on, Flat pleated,3 layers	Similar
	Outerlayer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Middlelayer	Melt blown polypropylene filter	Melt blown polypropylene filter	Same
Material	Innerlayer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Nose clip	Iron and Polyethylene	Polyethylene	Different
	Ear loops	Nylon and Spandex	Nylon and Spandex	Same

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Color	Green	Blue	Different
Dimension(Length)	175mm+/-8mm	175mm+/-5%	Similar
Dimension(Width)	95mm+/-5mm	95mm+/-5%	Similar
OTC use	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
ASTM F2100level	Level 3	Level 2	Similar

The proposed device has different material of nose piece and different color to the predicate device, while the proposed device has been tested and the test results shown that the material differences do not affect the safety of the proposed device.

The proposed device is similar in design, intended use, technological characteristics, and is composed of the same or similar components as the predicate device. The product proposed under this premarket notification submission has the same or similar performance characteristics and conform to the same or similar standards. Differences between the Disposable Medical Surgical Mask and predicate devices did not raise any new concerns regarding safety and effectiveness.

F. Summary of Non-Clinical Test

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification / 510(k)] Submission issued on March 5, 2004:

A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks A
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by A Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
EN 14683, Medical Face Masks-Requirements and Test Methods; A
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
A ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
16 CFR 1610, Standard for the Flammability of clothing textiles; A

Test Methodology	Purpose	Acceptance Criteria	Results
Fluid ResistancePerformanceASTM F1862	The purpose of theperformance testing is to	29 out of 32 pass at 160 mmHg for level 3	31 out of 32 pass at 160 mmHg, 3 lots;PASS
Particulate FiltrationEfficiency ASTM F2299		≥ 98%	98.8%; 98.8%; 98.8%;PASS

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Bacterial FiltrationEfficiency ASTM F2101	demonstrate the functionalityof the subject device.	≥ 98%	99.8%; 99.8%; 99.8%PASS
DifferentialPressure (DeltaP) EN 14683 Annex C		< 6.0mmH2O/cm²	2.73mm H2O cm² ;2.73mm H2O cm² ;2.73mm H2O cm²;PASS
Flammability 16 CFR1610		Class 1	Class 1;PASS
Cytotoxicity	The purpose of the testing isto demonstrate the safety ofthe subject device.	Non-cytotoxic	Under the conditions of thestudy,the device is non-cytotoxic.
Irritation		Non-irritating	Under the conditions of thestudy,the device is non-irritating.
Sensitization		Non-sensitizing	Under the conditions of thestudy, the device is non-sensitizing

G. Summary of Clinical Test Conclusion

No clinical study is included in this submission.

н. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K203426.

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.