The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Device Description

Like the original iMESH Tacker, the modified iMESH Tacker is a sterile, single use device for the fixation of prosthetic material, such as a hernia mesh, onto soft tissue. The applicator features an articulating tip. The absorbable tack is made of synthetic polyester derived from a lactic acid and glycolic acid copolymer (PLA/PGA). The modified device's implantable Tack is violet colored. The Applicator is pre-loaded with up to 30 Tacks.

The iMESH Tacker is comprised of 3 parts:

An in-line handle,
A shaft with an articulating tip
The bio-absorbable Tacks

AI/ML Overview

This document is a 510(k) Special Summary for the THD Lap Ltd's modified iMESH Tacker (IMT). It describes a medical device, not a software algorithm, therefore the requested information regarding AI performance and studies is not applicable.

However, I can extract information about the acceptance criteria and the studies performed to demonstrate the device's safety and effectiveness in comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Strength Testing	Demonstrate adequate mechanical strength for its intended use.	Device passed all tests and successfully met all acceptance criteria.
Functional Testing	Demonstrate proper function and operation as intended.	Device passed all tests and successfully met all acceptance criteria.
In-vivo Degradation Tests	Demonstrate predictable and safe degradation in biological systems.	Device passed all tests and successfully met all acceptance criteria.
Mechanical testing	Demonstrate mechanical properties meet specifications.	Device passed all tests and successfully met all acceptance criteria.
Use simulation test	Demonstrate safe and effective performance during simulated use.	Device passed all tests and successfully met all acceptance criteria.
Endotoxin testing	Meet pyrogenicity limits.	Device passed all tests and successfully met all acceptance criteria.
Shelf life using real-time aging	Maintain sterility and functional integrity over its shelf life.	Device passed all tests and successfully met all acceptance criteria.

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

This document pertains to a physical medical device (tacker) and its manufacturing and material properties, not a data-driven AI device. Therefore, the concept of "test set" and "data provenance" (in the context of clinical data for AI) is not directly applicable. The "tests" mentioned are engineering and biological evaluations of the device itself. The document does not specify the sample sizes for these non-clinical tests (e.g., number of tacks tested for strength, number of animals for in-vivo degradation).

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 as the document describes non-clinical performance data for a physical device, not the validation of an AI algorithm based on expert-labeled data.

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

This is not applicable, as there is no mention of expert adjudication for a "test set" in the context of an AI algorithm. The performance evaluation is based on engineering and biological test results.

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. The device is a surgical tacker, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

This is not applicable. The device is a physical surgical instrument, not an algorithm.

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

For the non-clinical tests mentioned, the "ground truth" would be established by defined engineering standards, material specifications, and biological safety parameters. For example, for strength testing, the ground truth would be a measurement against a predetermined force threshold. For endotoxin testing, it would be a measurement against a regulatory limit.

8. The sample size for the training set

This is not applicable, as this is not an AI device.

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

This is not applicable, as this is not an AI device.

Summary

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

March 24, 2016

THD LAP Ms. Einat Duvdevany General Manager 1 Nirim St. Tel Aviv. Israel

Re: K153202

Trade/Device Name: iMESH Tacker Regulation Number: 21 CFR 878.4750 Regulation Name: Implant staple Regulatory Class: Class II Product Code: GDW Dated: February 23, 2016 Received: February 25, 2016

Dear Ms. Duvdevany:

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.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K153202

Device Name iMESH Tacker

Indications for Use (Describe)

The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Special 510(K) Summary

THD Lap Ltd's modified iMESH Tacker (IMT)

Date Prepared: 20 October, 2015

510(k) owner name:

Company name:	THD Lap Ltd
Address:	1st Nirim St.Tel AvivIsrael
Phone:	+972-52-6717051
Fax:	+972-3-5037673
E-mail:	Einat.Duvdevany@thdlap.com

Contact person:

Name:	Tali Hazan
Address:	Ramot-Naftali, 13830Israel
Phone:	+972-50-5292304
Fax:	+972-72-2448981
E-mail:	tali.hazan@talmed.co.il

Device Name:

Common or usual name: Implantable Staple Proprietary/Trade name: iMESH Tacker

Classification name iMESH Tacker has been classified as Class II device under the following classification name:

Name	ProductCode	21 CFR Ref.	Panel
Staples, implantable	GDW	878.4750	General & Plastic Surgery

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Predicate Device:

The modified iMESH Tacker is substantially equivalent to the originally legally marketed iMESH Tacker which was cleared under 510(k) number K110728.

Device description:

The iMESH Tacker is comprised of 3 parts:

An in-line handle,
A shaft with an articulating tip
The bio-absorbable Tacks

The modified iMESH Tacker is identical to the original iMESH Tacker with the exception of a change in the color of the tacks to violet, several minor internal changes and slight changes to packaging and certain components. We believe that none of these changes affect the substantial equivalency determination of the device with its predicate device.

Intended use:

The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

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Image /page/5/Picture/1 description: The image shows the logo for THD. The logo consists of the letters "THD" in a bold, dark blue font. Above the letters is a curved, yellow shape that resembles a swoosh. There is also a small yellow line extending from the bottom right of the letter "D".

Technological characteristics and Substantial Equivalence:

The modified IMT is substantially equivalent with the original IMT cleared under K110728 as identified above under 'predicate device' section.

Both new and predicate device have the same indications for use, same shape, design and characteristics. All changes that differs the new device from the original device (predicate) were fully addressed and evaluated.

Feature	iMESH Tacker- Predicate Device (K110728) -	Modified iMESH Tacker- New Device -
Indication for use	The iMESH Tacker is indicatedfor fixation of prosthetic materialto soft tissue in various minimallyinvasive and open general surgicalprocedures, such as hernia repair.	The iMESH Tacker is indicatedfor fixation of prosthetic materialto soft tissue in various minimallyinvasive and open general surgicalprocedures, such as hernia repair.
Single use	Yes	Yes
Supplied sterile	Yes	Yes
Materials	Same or Similar	Same or Similar
Environment of use	Hospitals, sub-acute careinstitutions and surgery centers	Hospitals, sub-acute careinstitutions and surgery centers
Patient population	Individuals undergoing procedureswhere prosthetic mesh is beingused.	Individuals undergoing procedureswhere prosthetic mesh is beingused.
	Delivery DeviceDesign	Handle with triggers
Tip design	Articulating tip	Articulating tip
Tacks pre-loaded intip	Yes	Yes
Tip material	Stainless steel	Stainless steel
Number of tacks pre-loaded	30	30
Tack shape	Helical	Helical
Biocompaibility	Yes	Yes
Technology	Manual	Manual
Mode of operation	Tack insertion using the Tacker	Tack insertion using the Tacker
Tack material	PLA/PGA	PLA/PGA
Tack color	Non-colored (Transparent/Natural)	Violet
Performances	Same (equivalent)	Same (equivalent)

The substantial equivalence table is following presented:

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Non-clinical performance data:

The following non-clinical tests were performed:

Strength Testing ●
. Functional Testing
In-vivo Degradation Tests .
Mechanical testing .
Use simulation test .
Endotoxin testing .
Shelf life using real-time aging .

The device passed all tests and successfully met all acceptance criteria.

Conclusions:

The evaluation of the THD Lap Ltd's Modified iMESH Tacker Device non-clinical tests, demonstrate that the device is as safe and as effective as the predicate device and that all performance tests' acceptance criteria were met. Therefore, we believe it is substantially equivalent to the iMESH Tacker legally marketed devices previously cleared.

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.