Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.

Device Description

The TIDI® Facemask are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of 100% SBPP. The nosepieces are made of aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The face mask covers the nose and mouth, and is secured to the face using ear loops.

AI/ML Overview

This document describes the TIDI® Facemask and its non-clinical performance data to demonstrate substantial equivalence to predicate devices, as part of a 510(k) submission (K100800). The information provided is for a medical face mask, and thus the acceptance criteria and performance data are related to material performance rather than clinical diagnostic accuracy or reader studies.

Here's a breakdown of the requested information based on the provided text:

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

The device performance is benchmarked against the requirements of ASTM F-2100-07, "Standard Specification for performance of Materials Used in Medical Face Masks." The document states that the TIDI® Facemask "meet the requirements" of this standard.

Performance Metric	Acceptance Criteria (ASTM F-2100-07 requirement)	Reported Device Performance (TIDI® Facemask)
Resistance to Penetration by Synthetic Blood (ASTM 1862-07)	Meets ASTM F-2100-07 requirements	Meets requirements of ASTM F-2100-07
Initial Efficiency of Materials to Penetration by Particulates Using Latex Spheres (ASTM F 2299-03)	Meets ASTM F-2100-07 requirements	Meets requirements of ASTM F-2100-07
Bacterial Filtration Efficiency (BFE) (ASTM 2101-07)	Meets ASTM F-2100-07 requirements	Meets requirements of ASTM F-2100-07
Flammability of Clothing Textiles (16 CFR Part 1610)	Meets 16 CFR Part 1610 requirements	Meets requirements of 16 CFR Part 1610

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for BFE, or number of synthetic blood penetration tests). The data provenance is non-clinical laboratory testing performed to established ASTM standards. The country of origin of the data is not specified beyond the fact that it's for a US FDA submission, suggesting the testing was likely conducted in a regulated environment in line with US standards. The data is retrospective in the sense that it was collected before the submission of the 510(k).

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

This question is not applicable in the context of this document. The "ground truth" for the performance of a medical face mask is established by validated standardized testing methods (ASTM standards) rather than expert consensus on diagnostic images or clinical outcomes. The tests themselves are designed to objectively measure material properties.

4. Adjudication method for the test set

Not applicable. As described above, the evaluation relies on objective, standardized laboratory test results, not on subjective interpretations requiring adjudication.

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 document is for a medical face mask, which is a physical device, not an AI software or diagnostic tool that would involve human readers or MRMC studies.

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

Not applicable. This is not an AI algorithm but a physical medical device.

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

The "ground truth" for the TIDI® Facemask's compliance is the results obtained from standardized laboratory tests performed according to the specified ASTM standards. These standards define objective pass/fail criteria for material performance.

8. The sample size for the training set

Not applicable. This is not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for a physical device.

Summary

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Image /page/0/Picture/0 description: The image is a logo for TIDI Products. The logo features a stylized letter "T" with a swooping design, followed by the word "TIDI" in bold, sans-serif font. Below "TIDI" is the word "PRODUCTS" in a smaller, stylized font. The tagline "Care with Confidence" is placed beneath the main logo in a simple, sans-serif font.

NEENAH W RODUCTS LLC

Certmeo in ISO 9001:2000, EN ISO 13485:2003, European CE Mak

K100800

510(k) Summary TIDI® Facemask

To: Whom it may concern

Date: May 21, 2010

JUN 1 4 2010

Submitter/ Contact - Name and Address

Dion J. Brandt Quality Manager TIDI Products, LLC 570 Enterprise Drive Neenah WI 54956 Telephone: (920) 751-4386 (920) 751-4370 Fax:

FDA Registration Number: 2182318

Device Details:

Name of the Device

Trade Name: Or Customer Specific trade name Model: Procedure Common Name: Surgical Mask Classification Name: Mask, Surgical Product Code: FXX Regulation Number: 878.4040

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Equivalent Legally Marketed Device: Predicate Devices

TIDI® Face mask Model 9010 and 9020 2) A.R. Medicom Non-Sterile Surgical Mask 510 K Number: K092580 K051291

DESCRIPTION OF THE DEVICE:

INTENDED USE:

The TIDI® Facemask intended use is: Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.

Device and Predicate Device Technical Characteristics Summary

TIDI® Facemask has the same intended use and is technologically similar to the predicate device. The TIDI® Facemask and the predicate device are pleated, multi-ply, design and consist of non-woven barrier materials selected and arranged in such a manner as to provide optimal breathability and particulate filtration. Table 5.1 compares the TIDI® Facemask technical characteristics to the predicate devices

Page 5.2

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Table 5.1 Device and Predicate Device Technical Characteristics
Summary

. . . . .

Description	TIDI® FacemaskModel: Procedure	Predicate DeviceTIDI® FacemaskModel 9010 and 9020K092580	Predicate DeviceA.R. MedicomNon-Sterile Surgical MaskK051291
Material CompositionType of fabric:
Outer Layer	PolypropyleneSpun-bond	PolypropyleneSpun-bond	PolypropyleneSpun-bond
Filter Media	Melt-blownpolypropylene	Melt-blownpolypropylene	Melt-blownpolypropylene
Inner Layer	PolypropyleneSpun-bond	PolypropyleneSpun-bond	PolypropyleneSpun-bond
Other Materials:
Nose Piece:	Aluminum	Aluminum	Aluminum
EarAttachment:	Elastic	Elastic	Elastic
Anti-Fog	Polyester Urethanefoam	Polyester Urethane foam	none
		The difference of the anti fog material is the polyester urethane foam. The polyester foam material has beenused in medical application on facemask for an anti-fog strip without any toxicity or biological compatibilityissues. It has been proven to be non-toxic, non-sensitizing, and non-irritating.
DesignFeatures:	Ear LoopFluid Resistant	Ear LoopFluid Resistant	Ear LoopFluid Resistant
Mask Style:	Flat Pleated	Flat Pleated	Flat Pleated
Sterile:	No	No	No

Page 5.3

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Non-Clinical Performance Data

TIDI® Facemask meet the requirements of ASTM F-2100-07, Standard Specification for performance of Materials Used in Medical Face Masks. The testing required for this specification are, ASTM 1862-07, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

ASTM F 2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres.

ASTM 2101-07 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus.

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles.

Conclusion:

The conclusions drawn from the intended use, technical characteristics and nonclinical testing demonstrate that the TIDI® Facemask is as safe, as effective, and performs as well as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol resembling an eagle or bird with three wing-like shapes, positioned above a wavy line, representing the department's commitment to health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dion Brandt Quality Manager TIDI Products, LLC 570 Enterprise Drive Neenah, Wisconsin 54956

Re: K100800

JUN 1 4 2010

Trade/Device Name: TIDI Facemask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: March 18, 2010 Received: March 22, 2010

Dear Mr. Brandt:

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. 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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Page 2- Mr. Brandt

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Runow

Y Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Medical Devices

Indications for Use Form

Indications for Use

510(K) Number (if Known): K100800

Device Name: TIDI® Facemask - Model -Procedure

Prescription use (Part 21 CFR 801 Subpart D) AND/OR Over- The Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K100800

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.