The Stryker T4 Hytrel Zipper Toga is a component of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Device Description

The Stryker Personal Protection Systems include a self-contained ventilation helmet, a hood, a toga, rechargeable battery, and accessories.

AI/ML Overview

The provided text describes a 510(k) summary for a surgical garment, the Stryker T4 Hytrel Zipper Toga. This document outlines the device's equivalence to previously cleared devices rather than presenting a study proving performance against specific acceptance criteria in the manner typically seen for AI/ML or diagnostic devices.

Therefore, many of the requested categories related to AI/ML or diagnostic device studies (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

However, the submission does refer to performance tests demonstrating equivalence, which can be interpreted as meeting acceptance criteria by showing it is "equivalent to or better than" a predicate device.

Here's the information extracted and adapted to the context of this device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated by Predicate)*	Reported Device Performance (Stryker T4 Hytrel Zipper Toga)
Equivalent or better performance in barrier properties as the predicate device (Stryker Steri-Shield System).	Material used on front and sleeves shown to be equivalent to or better than the material used on the predicate device.
Performance demonstrated through specific tests: viral penetration, synthetic blood penetration, water resistance (impact penetration, hydrostatic pressure), flammability, and tear resistance.	The new device's material met or exceeded the performance of the predicate device's material in these specific tests.

*The acceptance criteria are inferred from the claim of equivalence to the predicate device and the battery of tests performed.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the summary. The document states that the material was "shown to be equivalent to or better than" the predicate device's material, but it does not detail the specific sample sizes used for the penetration, resistance, or flammability tests. Given the nature of material testing, the "test set" would refer to samples of the material itself, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This is not applicable. The "ground truth" for material performance is established through standardized laboratory testing methods, not expert consensus in the human health sense.

4. Adjudication Method for the Test Set

This is not applicable. Material performance tests follow established protocols and produce objective measurements, rather than requiring expert 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

This is not applicable. This device is a surgical garment and does not involve AI or human readers for diagnostic interpretation.

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

This is not applicable. This device is a surgical garment and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through standardized laboratory material testing (e.g., viral penetration, synthetic blood penetration, water resistance, flammability, tear resistance) against the performance characteristics of an already legally marketed and accepted predicate device.

8. The Sample Size for the Training Set

This is not applicable. This device is a surgical garment and does not involve AI/ML requiring a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable. This device is a surgical garment and does not involve AI/ML.

Summary

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510(k) Summary ______________________________________________________________________________________________________________________________________________________________________________

Ko40764

Trade Name:	Stryker T4 Hytrel Zipper Toga
Common Name:	Surgical gown and hood
Classification Name:	Surgical Apparel (per 21 CFR section 878.4040)
Equivalent to:	The Stryker T4 Hytrel Zipper Toga is equivalent to the zippertoga of the Stryker Steri-shield Personal Protection System(K944393, K011755). The material used on the front andsleeves of the Stryker T4 Hytrel Zipper Toga was shown to beequivalent to or better than the material used on the front andsleeves of the Stryker Steri-Shield Personal Protection System(K944393, K011755), as is detailed in Tab 4. Equivalence wasbased on the results of the following tests: Viral Penetration,Synthetic Blood Pentration, Water Resistance: ImpactPenetration, Water Resistance: Hydrostatic Pressure,Flammability, and Tear Resistance
Device Description:	The Stryker Personal Protection Systems include a self-containedventilation helmet, a hood, a toga, rechargeable battery, andaccessories.
Intended Use:	The Stryker T4 Hytrel Zipper Toga is a component of a personalprotection system that is intended to provide a barrier betweenthe operating environment and the members of the surgical teamin order to help protect against contamination and/or exposure ofinfectious body fluids and harmful microorganisms.
Technological	Technological characteristics are the same as previously clearedfor the Stryker Steri-Shield
Comparison:	Personal Protection System (K944393, K011755).
Submitted by:	Jennifer Mars, Regulatory Affairs RepresentativeStryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001Phone- 269-323-7700 ext. 3808Fax- 269-324-5412
Date Submitted:	March 17, 2004

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes and a stylized body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Stryker Instruments Corporation Ms. Jennifer Mars Regulatory Affairs Representative Instrument Division 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K040764

Trade/Device Name: The Stryker T4 Personal Protection System: Stryker T4 Hytrel Zipper Toga Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 16, 2004 Received: April 19, 2004

Dear Ms. Mars:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Mars

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

ChrLs

Chiu Lin. Ph.D. 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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Indications for Use Statement

510(k) Number	K040764
Device Name	The Stryker T4 Personal Protection System: Stryker T4 Hytrel Zipper Toga

Indications For Use The Stryker T4 Hytrel Zipper Toga is a component of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Prescription Use (Pcr 21 CFR 801 Subpart D) OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Morley

(Division Sign-Off) (Division Sign-On/) ----------------------------------------------------------------------------------------------------------------------------------------------------------Infection Control, Dental Devices

510(k) Number: K040764

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.