The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks 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, provided non-sterile and sterile.

Device Description

The proposed device, Disposable Surgical Mask is a three-layer, flat-folded mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The color of the surgical mask is blue. The disposable surgical mask is available in three different specifications: 17.59.5cm, 14.59.5cm and 14.5*8cm. The device is single use and provided non-sterile and sterile.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for a Disposable Surgical Mask, primarily focusing on proving substantial equivalence to a predicate device based on non-clinical performance standards. It explicitly states, "No clinical study is included in this submission." Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets acceptance criteria using clinical or AI-driven performance metrics.

The document outlines acceptance criteria for non-clinical tests (e.g., fluid resistance, particulate efficiency, bacterial filtration, differential pressure, flammability, biocompatibility) to demonstrate the proposed device performs as well as or better than the predicate surgical mask. However, these are physical and biological performance metrics for the mask itself, not measures of a complex device's performance in a clinical setting or where AI is involved.

Here's a breakdown of why I cannot fulfill your request based on the provided text, and what information is available related to performance:

Information NOT available in the provided document:

A table of acceptance criteria and the reported device performance related to a clinical or AI-driven study: The document presents a comparison table (page 5) of the proposed and predicate device's specifications and physical performance parameters, not clinical performance against acceptance criteria for a device involving AI or complex decision-making.
- For example, it states "Fluid Resistance: Pass at 160 mmHg" as a characteristic, which is a physical test result, not a clinical outcome or AI performance metric.
Sample size used for the test set and data provenance: Not applicable as no clinical or AI test set is mentioned.
Number of experts used to establish ground truth and qualifications: Not applicable as no ground truth for a clinical or AI study is established.
Adjudication method for the test set: Not applicable.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: "No clinical study is included in this submission." (page 7)
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable, as no AI/machine learning component is described.
How the ground truth for the training set was established: Not applicable.

Information related to "acceptance criteria" and "performance" that IS in the document, but for physical/biological mask properties:

The document lists performance measures for the physical characteristics of the surgical mask:

1. A table of acceptance criteria and the reported device performance (for physical/biological properties):

ITEM	Proposed Device Performance (Reported as "Pass at...")	Predicate Device Performance (Reported as "Passed at...")	Comparison
Fluid Resistance	Pass at 160 mmHg	Pass at 160 mmHg	Same
Particulate efficiency	Pass at >98.01%	Passed at 99.7%	Similar
Bacterial filtration	Pass at >98.12%	Passed at >99%	Similar
Differential Pressure	Pass at <4.6 mmH2O/cm2	Passed at 2.5 mmH2O/cm2	Similar
Flammability	Class 1	Class 1	Same
Biocompatibility: Cytotoxicity	No Cytotoxicity	No Cytotoxicity	Same
Biocompatibility: Sensitization	No Sensitization	No Sensitization	Same
Biocompatibility: Irritation	No Irritation	No Irritation	Same

2. Sample sizes for these physical/biological tests: Not explicitly stated in the document. The standards (e.g., ASTM, ISO) typically define the sample sizes for these types of tests.

3. Data provenance for these non-clinical tests: The tests were "conducted to verify that the proposed device met all design specifications" (page 6). This implies they were prospective tests performed on samples of the manufactured surgical masks. The country of origin for the manufacturer is China.

4. Experts involved in establishing ground truth for these non-clinical tests: Not applicable in the context of expert review of data/images. These are typically lab-based, standardized tests performed by qualified technicians following established protocols.

5. Adjudication method for these non-clinical tests: Not applicable.

6. Effect size of human readers improving with AI vs. without AI assistance: Not applicable as this is a surgical mask submission, not an AI device.

7. Standalone performance (algorithm only): Not applicable.

8. Type of ground truth for these non-clinical tests: For these physical and biological tests, the "ground truth" is defined by the objective results of the standardized test methods outlined (e.g., ASTM F1862/F1862M-17 for fluid resistance, ASTM F2101-2017 for BFE). These are laboratory measurements against accepted thresholds.

9. Sample size for the training set (for these non-clinical tests): Not applicable, as there's no machine learning training set involved.

10. How ground truth for training set was established (for these non-clinical tests): Not applicable.

In summary, the provided document is for a medical device (surgical mask) that is cleared based on its equivalence in physical and biological performance to a predicate device, as demonstrated through established non-clinical laboratory tests. It does not describe an AI-driven device or a clinical study that would involve the kind of acceptance criteria, test sets, and expert involvement you've asked about for an AI/clinical diagnostic device.

Summary

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February 12, 2021

Shanghai Jianzhong Medical Packaging Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K202341

Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 13, 2021 Received: January 14, 2021

Dear Diana 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. 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.

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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 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 (OS) 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.

For CAPT Elizabeth Claverie-Williams, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202341

Device Name Disposable Surgical Mask

Indications for Use (Describe)

Models: 17.59.5cm-3ply (sterile), 14.59.5cm-3ply (sterile), 14.58cm-3ply (sterile) 17.59.5cm-3ply (non-sterile), 14.59.5cm-3ply (non-sterile), 14.58cm-3ply (non-sterile)

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

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202341

Date of Preparation: 02/12/2021 1.
1. Sponsor Identification

Shanghai Jianzhong Medical Packaging Co., Ltd. Bldg 16, 789# Puxing Road, Minhang District, Shanghai 201114, P.R. China

Establishment Registration Number: 3005030944.

Contact Person: Nina Huang Position: Marketing Manager Tel: +86-21-54315666-5201 Fax: +86-21-54315801 Email: nina.huang@mpackchina.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Disposable Surgical Mask

Common Name: Surgical mask

Models: 17.59.5cm-3ply (sterile), 14.59.5cm-3ply (sterile), 14.5*8cm-3ply (sterile)

17.59.5cm-3ply (non-sterile), 14.59.5cm-3ply (non-sterile), 14.5*8cm-3ply (non-sterile)

Regulatory Information

Classification Name: Mask, Surgical; Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040; Review Panel: General Hospital;

Indication for use:

Models: 17.59.5cm-3ply (sterile), 14.59.5cm-3ply (sterile), 14.58cm-3ply (sterile) 17.59.5cm-3ply (non-sterile), 14.59.5cm-3ply (non-sterile), 14.58cm-3ply (non-sterile)

Device Description:

న. Identification of Predicate Device
510(k) Number: K160269 Product Name: Surgical Face Masks (Ear loops and Tie-on) Models: EL 10000, EL 10010, TO 10000, TO 10010 EL 20000, EL 20010, TO 20000, TO 20010 EL 30000, EL 30010, TO 30000, TO 30010

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6. Comparison of Technological Characteristics
ITEM	Proposed DeviceK202341	Predicate DeviceK160269	Comparison
Product Code	FXX	FXX	Same
RegulationNo.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indication forUse	The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks 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, provided non-sterile and sterile.Models: 17.59.5cm-3ply (sterile),14.59.5cm-3ply (sterile),14.58cm-3ply (sterile),17.59.5cm-3ply (non-sterile),14.59.5cm-3ply (non-sterile),14.58cm-3ply (non-sterile)	The surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks 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, provided non-sterile.Models: EL 10000, EL 10010, TO 10000, TO 10010, EL 20000, EL 20010, TO 20000, TO 20010, EL 30000, EL 30010, TO 30000, TO 30010	Similar
Configuration	ear strapnose clipmask body	ear strap/ Tie-onnose clipmask body	Similar
Dimension	17.59.5 cm14.59.5 cm14.5*8 cm	17.59 cm189 cm	Different
Level	Level III	Level III	Same
FluidResistance	Pass at 160 mmHg	Pass at 160 mmHg	Same
Particulateefficiencylevel	Pass at >98.01%	Passed at 99.7%	Similar
Bacterialfiltration level	Pass at >98.12%	Passed at >99%	Similar
Differentialpressure	Pass at <4.6 mmH2O/cm2	Passed at 2.5 mmH2O/cm2	Similar
Flammability	Class 1	Class 1	Same
Patient Contacting Material
Ear strap	Polyurethane	Polyester, polyurethane	Similar
Nose clip	Polyvinylchloride coated iron wire	Polyethylene coated steel wire	Different
Maskbody	Outer material	Polypropylene	Polypropylene	Same
	Middle material	Polypropylene melt-blown	Polypropylene spun bond andPolypropylene melt-blown	Similar
	Inner material	Polypropylene	Polypropylene	Same
	Pigment	Blue PCTG Pigment	Unknown	Different
Biocompatibility
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	Same
Sensitization	No Sensitization	No Sensitization	Same
Irritation	No Irritation	No Irritation	Same
Sterilization
Method	EO sterilized or non-sterile	Non-sterile	Different
SAL	10-6	/	Different

6. Comparison of Technological Characteristics

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7. Non-Clinical Test Conclusion

Non clinical 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:

A ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
A ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
A ASTM F2101-2017 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
A BS EN 14683 Medical face masks - Requirements and test methods, Annex C: Method for

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determination of breathability (differential pressure)

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Conclusion
  Based on the technological comparison and nonclinical tests described above, the subject devices, Disposable Surgical Masks, are as safe, as effective, and perform as well or better than the legally marketed predicate device cleared under K160269.

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.