The PointCore Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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 nonsterile.

Device Description

The PointCore Surgical Mask is a surgical mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The ASTM Level of the subject device is ASTM Level 2. The finished size of the mask is 175mm x 95 mm. The masks are comprised of three layers: an outer polyethylene/polyester layer, a meltblown nonwoven filter layer, and an inner polypropylene layer. The mask also includes an adjustable nose strip and flat or round elastic ear loop. The nosepiece is manufactured from a reinforced plastic piece with a metal insert.

AI/ML Overview

The provided text is a 510(k) Summary for the PointCore Surgical Mask and contains information regarding performance testing against established standards, which serve as acceptance criteria. However, it does not describe a study involving an AI/Machine Learning device or human readers. The document is for a medical device (surgical mask), not an AI diagnostic/screening tool. Therefore, many of the requested categories are not applicable to this submission.

Here's an analysis of the provided text against your requested criteria:

The document describes the performance testing of a PointCore Surgical Mask, a physical medical device, not an AI or machine learning algorithm. Therefore, many of your requested items regarding AI/ML studies, human readers, and ground truth establishment for AI models are not applicable.

However, I can extract the information relevant to the acceptance criteria and performance testing of the surgical mask:

1. A table of acceptance criteria and the reported device performance

The document references ASTM and other standards for performance testing. Here's a summary:

Performance Characteristic	Acceptance Criteria (Standard Reference)	Reported Device Performance (PointCore Surgical Mask)
Fluid Resistance	ASTM F1862	Passed acceptance criteria of ASTM F1862
Particle Filtration Efficiency	ASTM F2299	No specific numerical value reported, but implies meeting standard for ASTM Level 2 mask.
Bacterial Filtration Efficiency	ASTM F2101	No specific numerical value reported, but implies meeting standard for ASTM Level 2 mask.
Differential Pressure	MIL-M36945C	No specific numerical value reported, but implies meeting standard for ASTM Level 2 mask.
Flammability	16 CFR 1610	No specific numerical value reported, but implies meeting standard.
Biocompatibility	ISO 10993	No specific numerical value reported, but implies meeting standard.

Note: For filtration efficiency, differential pressure, and flammability, the document states that the mask is "ASTM Level 2." While the exact numerical criteria for Level 2 are not explicitly listed in this document, meeting ASTM Level 2 for these characteristics implies meeting specific numerical thresholds defined by the ASTM standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document only lists the standards used for testing (e.g., ASTM F1862) but does not detail the specific sample sizes used for each test or the provenance of the test materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The device is a surgical mask, and its performance is evaluated against standardized physical and biological tests, not against expert medical interpretations or diagnoses.

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

This is not applicable. As explained above, the device is a surgical mask and its performance is determined by objective laboratory tests based on established standards, not by human adjudication of diagnostic outputs.

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

This is not applicable. No AI component is described for this device, and no MRMC study or human reader assistance is relevant to the performance of a surgical mask.

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

This is not applicable. There is no algorithm or AI component in this device.

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

The "ground truth" for a surgical mask's performance is established by objective measurements against internationally recognized standards (e.g., ASTM, MIL-M, CFR, ISO). For example:

Fluid Resistance: Measured by resistance to penetration by synthetic blood.
Filtration Efficiency: Measured by the ability to filter out specific sizes of particles or bacteria.
Differential Pressure: Measured by breathability.
Flammability: Measured by flame spread rate.
Biocompatibility: Measured by absence of cytotoxic, irritating, or sensitizing effects as per ISO 10993.

8. The sample size for the training set

This is not applicable. There is no AI/ML model for this device that would require a training set.

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

This is not applicable. There is no AI/ML model for this 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). 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.

September 9, 2022

PointCore, Inc. % Mr. Dave McGurl Senior Director, Regulatory Affairs Mcra. LLC 803 7th Street, NW, 3rd Floor Washington, District of Columbia 20001

Re: K220944

Trade/Device Name: PointCore Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 31, 2022 Received: September 8, 2022

Dear Mr. McGurl:

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,

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220944

Device Name PointCore 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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K220944 Page 1 of 4

510(k) Summary

Device Trade Name:	PointCore Surgical Mask
Manufacturer:	PointCore, Inc.124 SW AdamsPeoria, IL 61602Phone: 309.404.4800
Contact:	Mr. Dave McGurlSenior Director, Regulatory AffairsMCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Office: 202.552.5798dmcgurl@mcra.com
Prepared by:	MCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Office: 202.552.5800
Date Prepared:	August 31, 2022
Regulation Number:	21 CFR §878.4040
Regulation Name:	Surgical Apparel
Regulatory Class:	II
Product Code(s):	FXX
Primary Predicate:	SAN-M PACKAGE CO., LTD. Surgical Face Masks (Ear loopsand Tie-on) (K160269)
Additional Predicate:	N/A
Indications For Use:

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Device Description:

Predicate Device:

PointCore submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the PointCore Surgical Mask is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to preamendment devices:

Primary Predicate: SAN-M PACKAGE CO., LTD. Surgical Face Masks (Ear loops and Tie-on) (K160269)

Performance Testing Summary:

The following testing was completed for the subject device:

Synthetic Blood Penetration Resistance
Particle Filtration Efficiency ●
Bacterial Filtration Efficiency
Differential Pressure Test
Flammability of Clothing Test ●

Substantial Equivalence:

Below is a summary table of the technological characteristics comparison between the subject and predicate devices.

Information	PointCore Surgical MaskSubject Device	Surgical Face Masks (Earloops and Tie-on)SAN-M PACKAGE CO.,LTD.K160269	Comparison
Classification	II	II	Identical
Regulation	878.4040	878.4040	Identical
Product Code	FXX	FXX	Identical
Indications	The PointCore Surgical Maskis intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulate	The surgical face masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulate	Identical
	Information	PointCore Surgical MaskSubject Device	Surgical Face Masks (Ear loops and Tie-on)SAN-M PACKAGE CO., LTD.K160269	Comparison
		material. These surgical 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 nonsterile.	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.
	Inner Layer	Polyethylene/Polyester White	Polypropylene
	Outer Layer	Polypropylene	Polypropylene
Materials	Middle Layer/ Filter Layer	Meltblown Nonwoven White	Polypropylene spunbondPolypropylene meltblown
	Ear Loops	Nylon/Spandex - Latex free	Ear loops: Polyester, polyurethaneSide tapes: Polyester spunbond (ear loops mask only)Tie tapes: Polypropylene spunbond or polyester spunbond	Similar
	Nose Piece	Reinforced plastic with metal insert	Polyethylene coated steel wire

	ASTM Level	Level 2	Level 1	Different
	Dimensions	$17.5 \pm 0.5$ cm x $9.5 \pm 0.5$ cm	• $17.5 \pm 0.5$ cm x $9 \pm 0.3$ cm• $18 \pm 0.5$ cm x $9 \pm 0.3$ cm	Similar
	Color	White	White or Blue	Similar
	Mask Style	Flat pleated, 3-ply	Flat pleated, 3-ply	Identical
	Design Features	Ear loop	Ear loop	Identical
	Sterility	Non-Sterile	Non-Sterile	Identical
	Use	Single Use	Single Use	Identical
Information	PointCore Surgical MaskSubject Device	Surgical Face Masks (Earloops and Tie-on)SAN-M PACKAGE CO.,LTD.K160269	Comparison
Fluid Resistance	Passed acceptance criteria ofASTM F1862	Passed acceptance criteriaof ASTM F1862	Identical
Particulate FiltrationEfficiency	ASTM F2299	ASTM F2299	Identical
Bacterial FiltrationEfficiency	ASTM F2101	ASTM F2101	Identical
Differential Pressure	MIL-M36945C	MIL-M36945C	Identical
Flammability	16 CFR 1610	16 CFR 1610	Identical
Biocompatibility	ISO 10993	ISO 10993	Identical

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Conclusion:

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. The PointCore Surgical Mask is as safe, as effective, and performs as well as, or better, than the predicate devices.

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.