The Livocare Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. The surgical mask is a single use, disposable device, provided non-sterile.

Device Description

The Livocare Surgical Mask is a single use, three-layer, flat-folded mask with ear loops and nose piece. The Surgical Mask is manufactured with three layers, 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 elastic ear loops welded to the surgical mask. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile. This device is not made from Natural Rubber Latex.

AI/ML Overview

The provided text is a 510(k) summary for the Livocare Surgical Mask (K201380). It details the device's technical characteristics, intended use, and comparison to a predicate device (K182515). However, this document does not describe a study involving an AI/Machine Learning device. Instead, it outlines the non-clinical performance testing for a surgical mask, an entirely different type of device.

Therefore, I cannot extract information related to acceptance criteria and studies for an AI/ML device because the provided text is about a physical medical device (a surgical mask).

If you have a document describing an AI/ML device, please provide it, and I will be happy to answer your request.

Based on the provided document for the LIVOCARE SURGICAL MASK:

I will extract the requested information as it pertains to this surgical mask, even though it's not an AI/ML device, to demonstrate the structure of the answer you're looking for, given the limitations of the input.

Acceptance Criteria and Study for Livocare Surgical Mask (K201380)

This document describes the premarket notification for a physical medical device, a surgical mask, not an AI/Machine Learning device. Therefore, the "study" described refers to non-clinical performance testing rather than an AI model's performance. Many of the requested categories are not applicable to the evaluation of a surgical mask (e.g., number of experts for ground truth, adjudication method, MRMC study, training set).

1. Table of acceptance criteria and the reported device performance:

Performance Test	Acceptance Criteria (Level 2)	Reported Device Performance (Livocare Surgical Mask)	Results
Fluid Resistance (ASTM F1862)	29 out of 32 pass at 120 mmHg	32 out of 32 passed at 120 mmHg	Pass
Particulate Filtration Efficiency (ASTM F2299)	≥98%	> 98%	Pass
Bacterial Filtration Efficiency (ASTM F2101)	≥98%	> 99%	Pass
Differential Pressure (Delta P) (MIL-M-36954C)	< 6.0 mmH₂O/cm²	< 5.0 mmH₂O/cm²	Pass
Flammability (16 CFR 1610)	Class 1	Class 1	Pass
Cytotoxicity	Non-cytotoxic	Non-cytotoxic (under study conditions)	Pass
Irritation	Non-irritating	Non-irritating (under study conditions)	Pass
Sensitization	Non-sensitizing	Non-sensitizing (under study conditions)	Pass

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

Fluid Resistance (ASTM F1862): The test involved 32 samples (implied from "32 out of 32 passed").
Other performance tests: Specific sample sizes for other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) are not explicitly stated, but the ASTM/MIL standards typically define the number of samples required.
Biocompatibility (Cytotoxicity, Irritation, Sensitization): Not specified, but standard biological evaluation batches would be used.
Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective/prospective outside of the standard testing protocol. It is implied these are prospective tests conducted on manufactured samples.

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

Not Applicable: For a surgical mask, "ground truth" is established by laboratory measurements according to recognized standards (e.g., ASTM, ISO). It does not involve human expert interpretation in the way an AI medical imaging device would. The tests are purely performance-based lab evaluations.

4. Adjudication method for the test set:

Not Applicable: As these are objective laboratory measurements, no human adjudication for interpreting results is mentioned or would typically be required beyond standard laboratory quality control.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Not Applicable: This is a physical device (surgical mask), not a diagnostic device involving human reader interpretation. No MRMC study was performed or is relevant for this device.

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

Not Applicable: This is a physical device; there is no algorithm or human-in-the-loop component. The "standalone performance" refers to the intrinsic performance of the mask itself under specified test conditions.

7. The type of ground truth used:

Objective Laboratory Measurements/Standardized Test Results: The "ground truth" is defined by the physical and chemical properties of the mask as measured by standardized testing protocols (e.g., fluid penetration, filtration efficiency, flammability, biocompatibility assays).

8. The sample size for the training set:

Not Applicable: This is a physical device, not an AI/ML model. There is no concept of a "training set" in the context of its premarket evaluation.

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

Not Applicable: As per #8, there is no training set.

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.

October 7, 2020

Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, Tianjin 300190 China

Re: K201380

Trade/Device Name: Livocare Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 8, 2020 Received: July 10, 2020

Dear Liu Yi:

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 Elizabeth Claverie 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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Indications for Use

510(k) Number (if known) K201380

Device Name

Livocare Surgical Mask

Indications for Use (Describe)

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

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

_ | 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

(In accordance with 21 CFR 807.92)

1.0 Submitter's information

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping Street, Ya An Road, Nankai District, TianjinP. R. China
Phone number:	86-22-87611660
Fax number:	86-22-87612379
Contact:	Liu Yi
Date of preparation:	October 5, 2020

2.0 Device information

Livocare Surgical Mask Trade name: Common name: Surgical mask Regulation name: Surgical Apparel

3.0 Classification

Product code: FXX Regulation number: 21 CFR §878.4040 Classification: Class II Panel: General Hospital

4.0 Predicate device information

WUHAN DYMEX HEALTHCARE CO., LTD Manufacturer: SURGICAL FACE MASK Device: 510(k) number: K182515

5.0 Intended use

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practices to reduce potential exposure to blood and body fluids. The surgical mask is a single use, disposable device, provided non-sterile.

6.0 Device description

This device is not made from Natural Rubber Latex.

Item	Subject Device	Predicate Device (K182515)	Comparison
Manufacturer	Andon Health Co., Ltd	WUHAN DYMEXHEALTHCARECO., LTD	-
510K number	K201380	K182515	-
Product name	Livocare surgical	Surgical face mask	-
Classification	Class II, FXX, 21 CFR878.4040	Class II, FXX, 21 CFR878.4040	Same
Indications for Use	The Livocare Surgical Mask isintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. The surgical mask isintended for use in infectioncontrol practices to reducepotential exposure to bloodand body fluids. The surgicalmask is a single use,disposable device, providednon-sterile.	The Surgical Face Masks areintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s), provided non-sterile.	Same

7.0 Comparison of technological characteristics with predicate device

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Model		Ear loops, flat pleated, 3 layers	Ear loops, flat pleated, 3 layers	Same
Materials	Outerlayer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Middlelayer	Melt blown polypropylene filter	Melt blown polypropylene filter	Same
	Innerlayer	Spun-bond polypropylene	Spun-bond polypropylene	Same
	Nosepiece	Malleable polyethylene wire	Malleable polyethylene wire	Same
	Earloops	Spandex and Nylon	Spandex	Similar
Color		Outer layer: BlueMiddle and inner layers: White	Yellow	Different
Dimension (Width)		$9.5 \pm 1.0$ cm	$9.5 \pm 0.2$ cm	Same
Dimension (Length)		$17.0 \pm 1.0$ cm	$17.5 \pm 0.2$ cm	Similar
OTC use		Yes	Yes	Same
Sterility		Non-sterile	Non-sterile	Same
Use		Single Use, Disposable	Single Use, Disposable	Same
ASTM F2100 Level		Level 2	Level 2	Same

8.0 Non-clinical testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications as the predicate device. The test results demonstrate that the proposed device conforms to the recognized standards ASTM F2100-19, ASTM F1862, ASTM F2101, and ISO 10993 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.

Performance testing:
Item	Acceptance criteria(Level 2)	Proposed device	Predicate device(K182515)	Results
Fluid ResistanceASTM F1862	29 out of 32 pass at120 mmHg	32 out of 32 passed at120 mmHg	32 out of 32 passedat 120 mmHg	Pass
Particulate FiltrationEfficiency ASTM F2299	≥98%	> 98%	99.7%	Pass
Bacterial FiltrationEfficiency ASTM F2101	≥98%	> 99%	99.9%	Pass
Differential Pressure (Delta P)MIL-M-36954C	< 6.0mmH₂O/cm²	< 5.0mmH₂O/cm²	4.0mmH₂O/cm²	Pass
Flammability16 CFR 1610	Class 1	Class 1	Class 1	Pass

Performance testing:

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ltem	Proposed device	Result
Cytotoxicity	Under the conditions of the study, the subjectdevice extract was determined to be non-cytotoxic.	Pass
Irritation	Under the conditions of the study, the subjectdevice non-polar and polar extracts weredetermined to be non-irritating.	Pass
Sensitization	Under the conditions of the study, the subjectdevice non-polar and polar extracts weredetermined to be non-sensitizing.	Pass

Biocompatibility testing:

9.0 Clinical Test

No clinical study is included in this submission.

10.0 Comparison to the predicate device and conclusion

The subject and predicate devices have the same intended use, design and mask materials. The difference between the two devices is their color, which should not raise different questions of safety and effectiveness.

The conclusion 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 K182515 Surgical Face Mask from Wuhan Dymex Healthcare.

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.