The Purism 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.

Device Description

The Purism Disposable Surgical Masks are manufactured with 3 layers, the inner facing layer and outer facing layer are composed of non-woven fabric, the middle layer is made up of melt-blown fabric. The surgical masks are single use, flat-folded with ear loops. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The Surgical Masks are sold non-sterile and are intended to be disposable mask.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a medical device: "Purism Disposable Surgical Mask". This document does not describe an AI/ML-driven medical device, nor does it detail a study involving AI assistance for human readers or a standalone AI algorithm. It's a standard regulatory submission for a physical medical product (a surgical mask) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

Therefore, many of the requested items related to AI/ML device studies (such as MRMC studies, human reader improvement with AI, ground truth establishment for training sets, etc.) are not applicable to this document.

However, I can extract information related to the acceptance criteria and the study (non-clinical testing) that proves the device meets these criteria, as detailed in the document.

Here's the breakdown based on the provided text, addressing the applicable points:

Device Name: Purism Disposable Surgical Mask
Regulatory Class: Class II
Product Code: FXX
Regulation Name: Surgical apparel (21 CFR 878.4040)
Predicate Device: K182514 Disposable Surgical Face Mask (Xiantao Zhibo Non-woven Products Co., Ltd)

1. Table of Acceptance Criteria and Reported Device Performance

The document presents non-clinical performance testing and biocompatibility testing.

Non-Clinical Performance Testing:

Performance Testing Standard	Purpose	Acceptance Criteria	Reported Device Performance
Fluid Resistance	To evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood.	At least 29 out of 32 specimens per lot show passing results at 160 mmHg	94 out of 96 pass at 160mmHg
Particulate Filtration Efficiency (PFE) ASTM F2299	To determine the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres.	≥ 98% Average PFE for all samples tested	96/96 Samples Pass at Average of 99.90%
Bacterial Filtration Efficiency (BFE) ASTM F2101	To measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.	≥ 98% Average BFE for all samples tested	96/96 Samples Pass at Average of 99.88%
Differential Pressure (Delta P) EN 14683	To determine the pressure required to breathe through the final manufactured face mask.	Samples must be < 6.0 mm H2O/cm²	96/96 Samples Pass at Average of 4.1mmH2O/cm²
Flammability 16 CFR 1610	The purpose of this standard is to reduce danger of injury and loss of life by providing, on a national basis, standard methods of testing and rating the flammability of textiles and textile products for clothing use, thereby prohibiting the use of any dangerously flammable clothing textiles.	All samples must be Class I	96/96 Samples Pass for Class 1

Biocompatibility Testing:

Performance Testing (Biocompatibility)	Purpose	Acceptance Criteria	Reported Device Performance
Cytotoxicity ISO 10993-5	Under the research conditions, determine whether the target device extract is cytotoxic.	The sample is non-cytotoxic.	Under the conditions of the study, the device is noncytotoxic.
Irritation ISO 10993-10	Under the research conditions, determine whether the non-polar and polar extracts of the target device are sensitive.	The sample is non-irritating.	Under the conditions of the study, the device is nonirritating.
Sensitization ISO 10993-10	Under the research conditions, determine whether the non-polar and polar extracts of the target device are irritating.	The sample is non-sensitizing.	Under the conditions of the study, the device is non-sensitizing.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set (Non-Clinical):
- For Fluid Resistance: 96 specimens were tested (indicated by "94 out of 96 pass" and acceptance criterion "29 out of 32 specimens per lot"; 96 suggests 3 lots of 32, or a total of 96 samples tested to ensure sufficient statistical power).
- For Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability: 96 samples were tested for each.
Data Provenance: The testing was conducted by or on behalf of Chuzhou Daddy's Choice Science and Technology Co., Ltd., based in Chuzhou City, Anhui, China. The data is from non-clinical laboratory testing specifically for this 510(k) submission. It is by nature "prospective" for the purpose of this submission, as it was generated to demonstrate compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML device requiring expert interpretation of images or other data for ground truth. The "ground truth" for these tests is the quantitative measurement results from standardized laboratory procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device requiring human adjudication of data. Compliance is determined by objective laboratory measurements against predefined acceptance criteria.

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 not an AI/ML device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device. No standalone algorithm performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For non-clinical performance and biocompatibility testing, the "ground truth" is defined by the standardized test methods and their objective quantitative results. For example:

Fluid Resistance: Visual observation of synthetic blood penetration after impact.
Filtration Efficiencies: Quantitative measurement of particle/bacteria concentration reduction.
Differential Pressure: Measurement of pressure differential across the mask material.
Flammability: Classification based on burn characteristics.
Biocompatibility: In-vitro (cytotoxicity) or in-vivo (irritation, sensitization) biological responses observed in laboratory models, interpreted against established biological safety evaluation criteria (e.g., ISO 10993 series).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

In summary, the provided document describes a traditional medical device (surgical mask) and its non-clinical testing for 510(k) clearance, which relies on standardized physical and chemical performance tests rather than AI/ML methodologies.

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: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 28, 2021

Chuzhou Daddy's Choice Science and Technology Co., Ltd. % Nickita Alexiades Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck. New York 11021

Re: K210856

Trade/Device Name: Purism Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 6, 2021 Received: July 12, 2021

Dear Nickita Alexiades:

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,

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) K210856

Device Name Purism Disposable 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

The assigned 510(k) number is K210856

1. Submitter's Identification:

Manufacturer:	Chuzhou Daddy's Choice Science and Technology Co., Ltd.
Address:	Middle of Nanjing Road,Langya District,Chuzhou City,Anhui,China
Contact Person:	Chaozhong Song
Tel:	+8618310114997
Email:	scz1976@163.com
Date Summary Prepared:	March 18, 2021
Official Correspondent:	Mr. Nickita AlexiadesMdi Consultants, Inc.
Address:	55 Northern Blvd. Suite 200, Great Neck, NY, United States
Tel:	201-220-2152
Email:	nickita@mdiconsultants.com

2. Name of the Device:

Device Trade Name: Purism Disposable Surgical Mask Classification Name: Surgical Face Mask Regulatory Class: II Product Code: FXX Regulation Name: Surgical Apparel Regulation Number: 878.4040

3. Information for the 510(k) Cleared Device (Predicate Device):

K182514 Disposable Surgical Face Mask Xiantao Zhibo Non-woven Products Co., Ltd

4. Device Description:

5. Indications for Use:

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Table 1: Technological Characteristics Comparison
Device	Proposed device	Predicate device	Result
510(k)	K210856	K182514	-
Manufacturer	Chuzhou Daddy's Choice Science and Technology Co., Ltd	Xiantao Zhibo Non-woven Products Co., Ltd	-
Product Name	Purism Disposable Surgical Mask	Surgical Face Mask	Similar
Classification	Class II Device FXX (21 CFR878.4040)	Class II Device FXX (21 CFR878.4040)	Similar
Indications for Use	The Purism 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.	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(s), provided non-sterile.	Similar
Material	Outer facing Layer	Spun-bond polypropylene	Spun-bond polypropylene	Similar
	Middle layer	Melt blown polypropylene filter	Melt blown polypropylene filter	Similar
	Inner facing layer	Spun-bond polypropylene	Spun-bond polypropylene	Similar

6. Technological Characteristics Comparison:

Nosepiece	Polyethyleneand iron wire	Malleable aluminumwire	Similar
---------------	-------------------------------	----------------------------	---------

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	Nylon / Polyurethanecomposites	Polyester	Similar
Model	Earloops 3-layersFlat Pleated	Ear loops3-layersFlat Pleated	Similar
Color	Blue	White	Different
Dimension(width)	$17.5cm±0.5cm$	$17.5cm±1cm$	Similar
Dimension(length)	$9.5cm±0.5cm$	$9.5cm±1cm$	Similar
OTC use	Yes	Yes	Similar
Sterility	Non-sterile	Non-sterile	Similar
Use	Single Use,Disposable	Single Use,Disposable	Similar
ASTM F2100 Level	Level 3	Level 2	Similar
Non-Clinical Testing	ASTMF1862ASTMF2299ASTMF2100ASTMF2101EN1468316 CFR 1610	ASTM F1862ASTM F2299ASTM F2100ASTM F210116 CFR 1610	Similar
BiocompatibilityTesting	CytotoxicityIrritationSensitization	CytotoxicityIrritationSensitization	Similar

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7. Summary of Non-Clinical Tests:

The following testing was conducted to demonstrate that the subject device met the acceptance criteria or the performance specification of the test methodology or standard provided in the tables below:

Performance TestingStandard	Purpose	Acceptance Criteria	Results
Fluid ResistancePerformanceASTM F1862	To evaluate the resistanceof medical face masks topenetration by the impactof a small volume (~2mL) of a high-velocitystream of synthetic blood.	At least 29 out of 32specimens per lotshow passing resultsat 160 mmHg	94 out of 96 pass at160mmHg
Particulate FiltrationEfficiencyASTM F2299	To determine the InitialEfficiency of MaterialsUsed in Medical FaceMasks to Penetration byParticulates Using Latex.Spheres	≥ 98% Average PFEfor all samples tested	96/96 Samples Pass at Averageof 99.90%
Bacterial FiltrationEfficiencyASTM F2101	To measure the bacterialfiltration efficiency (BFE)of medical face maskmaterials, employing aratio of the upstreambacterial challenge todownstream residualconcentration to determinefiltration efficiency ofmedical face maskmaterials.	≥ 98% Average BFEfor all samples tested	96/96 Samples Pass at Averageof 99.88%
Differential Pressure(DeltaP)EN 14683	To determine the pressurerequired to breathethrough the finalmanufactured face mask.	Samples must be <6.0 mm H2O/cm²	96/96 Samples Pass at Averageof 4.1mmH2O/cm2
Flammability16 CFR 1610	The purpose of thisstandard is to reducedanger of injury and lossof life by providing, on anational basis, standardmethods of testing andrating the flammability oftextiles and textileproducts for clothing use,thereby prohibiting the useof any dangerously	All samples must beClass I	96/96 Samples Pass for Class 1

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flammable clothingtextiles.
---------------------------------	--	--	--

Performancetesting(Biocompatibility)	Purpose	Acceptance Criteria	Results
CytotoxicityISO 10993-5: Biologicalevaluation of medical devices- Part 5: Tests for in vitrocytotoxicity	Under the researchconditions,determinewhether the targetdevice extract iscytotoxic.	The sample is non-cytotoxic.	Under the conditions ofthe study, the device isnoncytotoxic.
IrritationISO 10993-10: Biologicalevaluation of medical devices-Part 10: Tests for irritationand skin sensitization	Under the researchconditions,determine whetherthe non-polar andpolar extracts of thetarget device aresensitive.	The sample is non-irritating.	Under the conditions ofthe study, the device isnonirritating.
SensitizationISO 10993-10: Biologicalevaluation of medicaldevices-Part 10: Tests forirritation and skinsensitization	Under the researchconditions,determine whetherthe non-polar andpolar extracts of thetarget device areirritating.	The sample is non-sensitizing.	Under the conditions ofthe study, the device isnon-sensitizing

Table 3 Biocompatibility testing

8. Discussion of Clinical Tests Performed:

No clinical study is included in this submission.

2. Conclusions:

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Xiantao Zhibo Medical Product Disposable Face Mask cleared under K182514.

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.